Portaria 54/2016 Inmetro English

Ordinance No.
54/Presi, dated 02/01/2016

Federal Public Service
MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE

BRAZILIAN INSTITUTE OF METROLOGY, STANDARDIZATION AND INDUSTRIAL QUALITY -
INMETRO
Ordinance No. 54, dated February 1st, 2016.
THE PRESIDENT OF BRAZILIAN INSTITUTE OF METROLOGY,

STANDARDIZATION AND INDUSTRIAL QUALITY – INMETRO, using his attributions,
granted in paragraph 3rd of article 4th of Law No. 5.966, dated December 11, 1973, in subsections I
and IV of article 3rd of Law No. 9.933, of December 20, 1999, and in subsection V of article 18 of
Regimental Structure of the Autarchy, approved by Decree No. 6.275, dated November 28, 2007;
Considering subparagraph f of item 4.2 of the Reference Term of the Brazilian Compliance
Assessment System, approved by Resolution Conmetro No. 04, dated December 2nd, 2002, which
attributes to the Inmetro the competence to set forth the guidelines and criteria for the compliance
assessment activity;
Considering Interministerial Directive MS/MDIC No. 692, dated April 8th, 2009, which
defines the operationalization of technical cooperation actions for Safety and Quality Assurance of
Medical Devices submitted to the sanitary control regime, as set forth in the Technical Cooperation
Term between the Ministry of Health (MS) and the Ministry of Development, Industry and Foreign
Trade (MDIC);
Considering Interministerial Directive MS/MDIC No. 16, dated December 17th, 2010, which
approves the internal rules of the Managing Committee of the Term of Cooperation celebrated
between the Ministry of Health (MS), with intermediation of the Sciences, Technology and Strategic
Inputs Department (SCTIE), the Ministry of Development, Industry and Foreign Trade (MDIC), with
the intermediation of the National Institute of Metrology, Quality and Technology (Inmetro), the
National Sanitary Surveillance Agency (Anvisa) and Fundação Oswaldo Cruz (Fiocruz), signed on
April 8th, 2009;
Considering Interministerial Directive MS/MDIC No. 206, dated June 21st, 2013, which
institutes the Technical Articulation Committee with the National Sanitary Surveillance System
within the sphere of Plano Brasil Maior (CTVSPBM);
Considering the publication of the new issue of the series of Technical Standards IEC 60601
and ISO/IEC 80601, including risk management, in a release internalized by the ABNT (ABNT NBR
IEC 60601 and ABNT NBR ISO/IEC 80601);
Considering the publication of Resolution RDC Anvisa No. 27, dated June 21st, 2011, which
provides on the procedures for compulsory certification of equipment under Sanitary Surveillance
regime;
Considering the publication of Normative Instruction Anvisa No. 4, dated September 10th,
2015, which approves the updated list of Technical Standards that must be adopted for compliance
certification, within the sphere of the Brazilian Compliance Assessment System (SBAC), of
equipment under Sanitary Surveillance regime;
Considering Inmetro Ordinance No. 118, dated March 6, 2015, which approves the improvement
of General Requirements for Product Certification (RGCP), published on Official Gazette of the
Federal Executive of March 09, 2015, section 01, page 76 to 77;
Ordinance No. 54/Presi, dated 02/01/2016
Considering the need to improve the Requirements of Compliance Assessment for Electrical
Equipment under Regime of Health Surveillance, defined in Inmetro Ordinance No. 350, dated
September 06, 2010, published in Official Gazette of the Federal Executive of September 09, 2010,
section 01, page 67, decides to issue the following provisions:
Article 1st – Approve the improvement of Compliance Assessment Requirements for

Equipment under Regime of Health Surveillance, available on website www.inmetro.gov.br or in
the address below:
National Institute of Metrology, Quality and Technology – Inmetro

Technical Regulations and Compliance Assessment Programs Division – Dipac
Rua da Estrela n.º 67 - 3º andar – Rio Comprido
CEP 20.251-900 – Rio de Janeiro – RJ
Article 2nd – To inform that the Public Consultation was developed by Inmetro Ordinance
No. 407, dated August 26, 2014, edited in Official Gazette of the Federal Executive, dated August
28, 2014, section 01, page 94, and had the technical help of industry and company in general for
preparing the Requirements approved herein.
Article 2nd – To inform that will be maintained, within the Scope of Brazilian System of
Compliance Assessment – SBAC, the voluntary certification for Equipment under regime of Health
Surveillance which shall be performed by Product Certification Organism – OCP, established in
Brazil and accredited by Inmetro, according to the Requirements approved herein.
Paragraph § 1st – These requirements apply to equipment, including its parts and accessories
for medical, dental, laboratory and physiotherapy purpose, directly or indirectly used for diagnosis,
treatment, rehabilitation and monitoring in humans, and equipment with beauty and aesthetics
enhancement purposes.
Paragraph § 2nd – The equipment not classified in Anvisa RDC No. 27/2011 and its
amendment is excluded from this Requirements.
Article 4th – To make it known to manufacturers and importers that Anvisa may demand the
compulsory certification of Equipment under Sanitary Surveillance Regime through IN or RDC.
Article 5th – To define manufacturers and importers with certificates issued according to
Inmetro Ordinance No. 350/2010, which shall be in compliance with the requirements approved
herein, on the date of renewal or maintenance thereof, respecting the limit terms set forth by
Normative Instruction Anvisa No. 4/2015 and its amendments.
Article 6th – To define that, as of the publication date of this Ordinance, the changes of
projects made in products after certification shall be notified to Inmentro and to Anvisa in
compliance with the requirements approved herein.
Article 7th – To defined that the new certification processes started after the publication date
of this Ordinance in the Official Gazette of the Federal Executive shall be in compliance with the
requirements approved herein.
Article 8th – To inform that the electromedical equipment in compliance with the
requirements approved herein will not be necessarily deemed safe if, when inspected and tested, is
found other features that may affect the safety encompassed by this Compliance Assessment
Program or result in hazards arising from electromagnetic phenomena that may jeopardize its
operation or of other equipment.
Article 9th – To establish that, as of 6 months, counted as of the publication date of this
Ordinance No. 54/Presi, dated 02/01/2016
Ordinance, the Equipment under Regime of Health Surveillance shall be certified in compliance
with the Requirements approved herein respecting the terms and conditions set forth in Anvisa
Normative Ruling No. 4, dated September 10, 2015 and its amendments.
Article 10th – To revoke the Inmetro Ordinance No. 350/2010 on December 31, 2022.
Article 11th – This Ordinance shall enter into force on its publication date in the Official
Gazette of the Federal Executive.
LUÍS FERNANDO PANELLI CESAR

ATTACHMENT OF INMETRO ORDINANCE No. 54/ 2016
REQUIREMENTS OF COMPLIANCE ASSESSMENT FOR

EQUIPMENT UNDER REGIME OF HEALTH SURVEILLANCE
1. PURPOSE
To establish the criteria and compliance assessment procedures for Equipment under Regimen of
Health Surveillance, focusing on security, through the certification mechanism, aiming the
prevention of accidents.
1.1 GROUPING FOR CERTIFICATION PURPOSES

The certification of Equipment under Regime of Health Surveillance must be executed by family, as
defined according the criterion established by Attachment D herein.
2. ACRONYMS
For purposes of this RAC, the following acronyms are adopted, complemented by acronyms
included in additional documents mentioned in chapter 3 herein:
AGR Risk Management File
Anvisa Brazilian Health Surveillance Agency
CBPFC Certificate of Good Manufacturing Practices and Control
CNPJ National Directory of Legal Entities Reg. No.
EM Electromedical
Remark: It includes the non-electrical equipment category under Regime of Health
Surveillance
GR Risk Management
IN Normative Instruction Anvisa
MDP Protection Means or Measures
MPO Operator Protection Means or Measures
MPP Patient Protection Means or Measures
PDS Software Development Plan
RDC Collegiate Board Resolution
RHProj Project History Record
RHP Product History Record
RMP Product Master Record
SDPD Software of Unknown Origin
SGR Risk Management Summary
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3. SUPPLEMENTARY DOCUMENTS
For the purposes of this RAC, the following supplementary documents are adopted:
Inmetro Ordinance No. It improves the General Requirements for Product Certification
03/06/2015
118 (RGCP).
and its amendments Inmetro Vocabulary of Compliance Assessment with terms and
Inmetro Ordinance No.
05/25/2015 definitions usually used by the Compliance Assessment Board
248 and its
of Inmetro.
amendments
Inmetro Ordinance No. Metrological Technical Regulation of digital electronic
03/20/2008
96 sphygmomanometers
and its amendments
Inmetro Ordinance No. Metrological Technical Regulation of digital clinical
04/06/2006
89 thermometers
and its amendments It sets breaches to the federal health legislation, defines the
Law No. 6.437 08/20/1977
respective sanctions and other measures.
It approves the list of technical standards that should be
adopted for compliance certification under the Brazilian
IN Anvisa No. 4 and
09/10/2015 System of Compliance Assessment (SBAC) for Equipment
its amendments
under Regime of Health Surveillance, pursuant to Anvisa RDC
Resolution No. 27 of June 21, 2011.
Provides on the Good Manufacturing Practices and Medical
RDC Anvisa No. 16 03/28/2013 Products for Diagnosis of In Vitro Use.
It provides for the compulsory of execution and notice of field

RDC Anvisa No. 23 04/04/2012 actions by holders of product registration for health in Brazil.
It provides on the procedures for mandatory certification of
RDC Anvisa No. 27 06/21/2011
Equipment under Regime of Health Surveillance.
It provides on technical surveillance standards applicable to
RDC Anvisa No. 67 12/21/2009
holders of product registration for health in Brazil.
General requirements for the competence of testing and
ABNT NBR ISO 17025:2005
calibration laboratories.
Compliance assessment - Requirements for certification bodies
of products, processes and services.
Electromedical equipment, Parts 1 and 2, general requirements
ABNT NBR IEC 60601 and specific requirements; internalized standards of the series
IEC 60601 3rd edition including its amendments and
corrigendum.
Electromedical equipment, particular requirements;
ABNT NBR ISO 80601 internalized standards of ISO 80601 series including its
amendments and corrigendum.
Health products – Quality management systems - Requirements
for regulatory purposes.
Health products - risk management application to health
products.
3.1 The general standard, collateral standard and particular standard shall be in versions
corresponding for use.
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4 DEFINITIONS
For purposes of this RAC, the following definitions and those included in supplementary documents
mentioned in item 3 are adopted:
4.1 Service
Service: maintenance or repair of a finished product in order to return it to its specifications [Anvisa,
RDC No. 16 of 2013, item 1.2.1]
4.1.1 Service – Extended definition [Inmetro].

It is the process where a professional with knowledge of specific technical content, provides
information and clarifications or performs actions to comply with identified needs including
maintenance or repair of a finished product in order to return it to its specifications:
4.1.1.1 It allows the collection of information relevant to the subject matter for project
improvement, quality improvement, effectiveness and efficiency of products, processes or services.
4.1.1.2 It contributes to the competitiveness of companies in the market, as well as strengthening
their quality management systems.
4.1.1.3 It depends directly on the skills and abilities developed by its employees, through
qualification and training, as well as the supplied material resources for its implementation.
4.1.1.4 It requires high priority in quality management systems, demonstrated at the continued
employment efforts with customers to solve problems.
4.1.1.5 It is suggested a structure characterized by:
a) use of performers who demonstrate knowledge and skill;
b)constant evaluation of training of performers in the application of knowledge to meet the needs of
customers;
c) use of “best practices” recognized and relevant normalizing and regulatory documents as a
response to specific issues; and
d)Use of several communication means with the customer.
4.2 Original characteristics

It encompasses the technical specification, use indication and purpose, physical features, including
the accessories and critical components list, chemical features (if applicable), the content of
attached documents and equipment marks, which constitute the project features of an equipment
during the product certification grant, and shall also correspond to the registered or enrolled
equipment features, or to be registered and enrolled, in Anvisa.
4.3 Critical components

Components that directly affect the safety of patient and/or user.
4.4 Usability Engineering

Application of knowledge on human behavior, abilities, limitations and other characteristics for the
project of electromedical equipment or system to be able to reach the adequate usability. [IEC
62366:2007, definition 3.8]
4.5 Routine (or production) test

Non-destructive test, conducted by the manufacturer, that provides an evidence of compliance of a
manufactured batch, at a given time, held at 100% of units of a product manufactured at the end or
in the course of a production line, to demonstrate that the assembly the product was performed
according to the project requirements and conditions specified by this RAC.
4.6 Type (or qualification) Test

Non-destructive test, conducted by the manufacturer, that provides an evidence of compliance of an
item, in a given time, held in one or more units of a product, to demonstrate that this product
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complies with the requirements specified in the project and is as evaluation requirements defined
based on national standards (ABNT), regional and international, and the conditions specified by this
RAC.
4.7 Large equipment for diagnosis or therapy:

Health application equipment used for diagnosis or therapy, of permanent installation in specially
built/adjusted environment for its operation, with network individualized and specific power,
requiring maintenance actions to be performed on its place of installation. Its installation is
conducted by a specialized team, usually requiring a formal commissioning for approval.
REMARKS: It constitute large size equipment, but not limited to, equipment of interventional
x-rays, nuclear medicine, computed tomography and magnetic resonance.
4.8 Manufacturer
Manufacturer is the company responsible for the project, manufacture, assembly, transformation or
processing of a finished product or system, packaging and labeling of a product, before being placed
on the market or into operation, regardless of whether these operations are conducted by that person
or on its behalf, by a third party.
4.9 Contract Manufacturer

Outsourced company, duly instituted as a legal entity, which carries out the industrialization of a
medical product under the responsibility of a Legal Manufacturer, upon a legally established
agreement.
NOTE: “Contract Manufacturer” (CM).
4.10 Legal Manufacturer

Legal entity responsible for the project, manufacture, packaging or labeling of a medical product,
setting up a system or adjust the product before it is placed on the market or into operation,
regardless of whether these operations are carried out by that person or on its behalf, by a third
party.
4.11 Family
The characterization of family is as provided in Attachment D of this
RAC.
4.12 Risk Management

Systematic application of policies, procedures and management practices to the risk analysis,
assessment, control and monitoring tasks. [ABNT NBR ISO 14971: 2009, item 2.22]
4.13 Normative Instruction Anvisa - IN

Is a normative act of the Anvisa Collegiate Board, which sets forth in exceptional character technical
requirements to be fulfilled by an object.
4.14 Master List of Quality Documents

This list is the index or equivalent procedures where all documents of the quality system are listed
(procedures, work instructions, etc.) and containing the indications of the releases of the documents
in effect.
4.15 Protection Methods

For an electromedical equipment or system connected by a structured cabling system, the
manufacturer shall state the protection means used for reducing the risk resulting from electric shock
(MDP), which is divided in two classes: Means of reduction of electric shock risk to patient (MPP);
and means of reduction of electric shock risk to the equipment operator (MPO).
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4.16 Serial or batch number

Distinctive combination of letters or numbers, or both, of which may be given the full history of
purchasing, manufacturing, packaging, labeling and distribution of finished products. [RDC 16
28/03/2013, item 1.2.15]
4.17 Essential productive process

It is the method, system or set of activities necessary for the generation of a product, with a given
critical purpose, applied from the beginning to the final product delivery.
4.18 Project Historic Record (RHProj)

Compilation of records containing the complete history of a finished product project.
4.19 Product Master Record (RMP)

Compilation of records containing the complete product designs, its formulation and specifications,
procedures and manufacturing and procurement specifications, procedures and quality system
requirements and procedures of the finished product on the packaging, labeling, technical
assistance, maintenance and installation.
4.20 Applicant
Legal, public or private entity, whether national or international, legally established in the country,
enrolled with CNPJ, that develops, at least, one of the following activities: production, assembly,
creation, construction, transformation, import, free distribution or not, or commercialization of
Equipment under Regime of Health Surveillance, covered by this RAC. It is responsible for the
certification request of the product by the OCP, has the responsibility to ensure the realization of the
planned routine tests set forth herein, holds the concession to use the Compliance Identification
Mark, being responsible for requesting registration and enrollment at Anvisa.
4.21 Risk Management Summary

The Risk Management Summary (SGR) is the fundamental document in prioritizing risk
management, due to the analysis and assessment, to define the acceptability, treatment and control
that must be given to each of the hazards or hazardous situations identified for an EM product or
system. Provides traceability to the application of the items of ABNT NBR ISO 14971 (clause 3.5 of
ABNT NBR ISO 14971) and supports the prioritizing of corrective actions, in addition to containing
the records of any project change. The SGR must also correlate, minimally, all requirements of the
standards applicable to the product that were established by a Normative Instruction, and its risk
management process (analysis, assessment, control and monitoring) pursuant to ABNT NBR ISO
14971, including the hazardous situations that were not provided for in the standards applicable to
the product, but were identified as relevant during risk analysis.
4.22 Pilot or Production Unit

The pilot or production unit corresponds to a product unit or group of units produced respecting the
criteria of the production process established in product design. The pilot unit uses materials that
will be used in the production of the product and the process and unique tooling necessary for their
manufacture, being built after a full risk management analysis by the manufacturer, through
evaluation and testing prior to certification.
5 COMPLIANCE ASSESSMENT MECHANISM

The Compliance Assessment Mechanism used herein is the Certification, applicable to Equipment
under Regime of Health Surveillance encompassed in this RAC.
6 COMPLIANCE ASSESSMENT STEPS

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The compliance assessment procedure consists of several steps and each step respects a sequence of
procedures. This chapter establishes the procedure for compliance assessment, which must follow
the requirements of RGCP complemented by this RAC.
6.1 Definition of Certification Model Used

This RAC establishes the Certification Model 5 – Type test, assessment and approval of the
manufacturer's Quality Management System, monitoring through audits at the manufacturer and
importers holding registration and enrollment, certification applicants, and testing on samples taken
from the manufacturer, conditioned by the evaluation and approval of the manufacturer's Risk
Management.
6.2 Initial Assessment

The Initial Certification Assessment must follow the provisions of RGCP.
6.2.1 Certification Request

The Certification Request starts with the budget request for certification and the criteria for
Certification Request must follow the RGCP provisions, observing the rules and deadlines
established by ANVISA Normative Ruling No. 4/2015 and its amendments, complemented by this
RAC.
6.2.1.1 It fully applies to the requirement 6.2.1.1 of RGCP.
6.2.1.2 It applies to the requirement 6.2.1.2 of RGCP:
6.2.1.2.1 The items “a”, “d”, “g”, “l”, “m”, “p” and Notes 1, 2, 3 and 4 are fully applied;
6.2.1.2.2 The item “b” is applied with the following text.

“List of model(s) that composes the certification object family, according to family formation rules
set out in Attachment D of this RAC, when the certification is for family, referencing its technical
description and including the list of all traded brand;”
6.2.1.2.3 The item “c” is completely excluded.
6.2.1.2.4 The item “e” is fully applied complemented by

“The list of technical rules, with justification, are part of the “Descriptive Memorial" defined by the
manufacturer as applicable to the product; identification, with justification, that the product is or is not
part of a family; identifying, in justification, the product is either part of an electromedical system;
and the description of the products that are part of the system, if applicable.”
6.2.1.2.5 The item “f” is fully applied complemented by the following text:
“The product's user manual, draft or final version according to ABNT NBR IEC 62366/2010, item 6
and section 5.1. The User Manual must specify the application of the health product in usability
engineering file. This specification should include whenever applicable:
a) Meaningful Performance Features:
i) medical indication for;
ii) the intended population of patients showing minimal age, weight, health and condition of
the patient;
iii)part of the body or tissue type on which it is applied or with which it interacts;
iv) User profile designed with an essay on an understanding level consistent with the intended
user profile; and
v) conditions of use intended indicating minimal environment for use, including hygiene
requirements; frequency of use; location and mobility.
b) A summary of the product application specification or "use declaration intended”;
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c) Operation principle; and
d) Significant constructive physical characteristics.”
6.2.1.2.6 The item “h” is fully applied, the only certification model is Model 5.
6.2.1.2.7 The items “i” e “j” are fully applied, replacing the term “Applicant Supplier” for
“Applicant”, according to definition 4.20 of this RAC;
6.2.1.2.8 The item “k” are fully applied, replacing the term “Manufacturer” for “Manufacturer,
Contractor Manufacturer and/or Legal Manufacturer, when applicable”, respectively according to
definitions 4.8. 4.9 and 4.10 herein;
6.2.1.2.9 The item “n” replaced by the following text;

“Documents relating to the management system of the manufacturer's quality, applicable to the
object to be certified as provided for in Attachment B, so that they will be audited by the OCP, as
provided herein”. As evidence of compliance with the requirements of Attachment B of this RAC
of the standard ABNT NBR ISO 13485:2004, it may be provided the final audit report to the
requirements of Attachment B, for the companies certified with valid certificates issued by OAC
accredited by Inmetro or member of IAF MLA in accordance with the ABNT NBR ISO
13485:2004.
6.2.1.2.10 The compliance with “o” is facultative;
6.2.1.2.11 The item “q” is excluded.
6.2.1.2.12 The item “r” is fully applied complemented by the following text:
“Other documents may be requested by the OCP, for the implementation of item 6.2.4 (Definition
of test plan).”
6.2.1.2.13 In addition to the documents referred to in RGCP, the manufacturer shall provide a
descriptive summary of risk management in accordance with ABNT NBR ISO 14971, General
Requirements for Risk Management, item 3 including:
a) High Administration Responsibilities, item 3.2.
b) Staff Training, item 3.3.
c) Risk Management Plan, item 3.4.
d) Risk Management Summary, item 3.5.
6.2.2 Request Analysis and Documentation Compliance

The criteria for the Request and Documentation Analysis should follow the requirements of
RGCP.
6.2.2.1 It applies to the requirement 6.2.2.1 of RGCP, in full.
6.2.2.2 It applies to the requirement 6.2.2.2of RGCP, in full.
6.2.2.3 It applies to the requirement 6.2.2.3of RGCP, in full.
6.2.2.4 Risk Management File Analysis

In this phase the applicant should submit the Risk Management File of the Manufacturer to
OCP. AGR will be analyzed OCP:
6.2.2.4.1 For preparation of the manufacturer's audit; and
6.2.2.4.2 For the preparation of the Test Plan, which sets out the tests necessary for the Product
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Compliance Assessment. The AGR must be followed minimally, among other documents, where
applicable, of:
a) technical specifications of product;
b) electrical schematics of the product;
c) identifying the functions of the equipment or system EM which are essential performances;
d) list of critical components;
e) selection criterion of high integrity components;
f) list of certified components and its respective certificates;
g) flammability classification for insulating materials;
h) insulation diagram including the MDP – MPP and MPO;
i) comparison indexes of threshing of solid insulating materials (CTI);
j) pollution degree;
k) wiring specifications;
l) insulation class of transformers, engines, electrical switches, lamp sockets, etc.;
m) equipment overvoltage category;
n) flaws and occurrences list;
o) Usability Engineering file;
p) Policy for establishing acceptable risk and residual risks acceptability;
q) Projects calculation of tensioning safety factor, for equipment bearing suspended masses
r) Documentation of Development Lifecycle for Programmable Electromedical Systems (SEMP),
with identification of hazards, risk control, Requirements Specification, architecture,
implementation project, verification, validation, modification and SEMP connection to other
equipment; and
s) risk management summary.
6.2.3 Initial Audit of Quality Management System and Evaluation of the Production Process
6.2.3.1 The requirement 6.2.3of RGCP is completely excluded
6.2.3.2 Initial Audits of Risk Management Systems (SGR) and Quality Management (SGQ)
and Production Process Evaluation
The Initial Audits of Risk Management System (SGR) and the Quality Management (SQG) and
Production Process Evaluation must be performed regardless of the Manufacturer or Applicant
bearing certified SGR and SGQ, based on the edition in force of ABNT NBR ISO 14971, ABNT
NBR IEC 60601-1 and ABNT NBR ISO 13485 rules, respectively, where applicable. The OCP
must evaluate the documents and records of the SGR and SGQ, and perform audit in the facilities of
the manufacturing unit, in order to verify the compliance of the production process, including
project, essential production process, product manufacturing, installation and training of personnel.
The audit shall seek objective evidence that the production process is systematic and monitored
effectively by providing evidence of compliance with quality management requirements and
product risk management established in RAC
6.2.3.2.1 The records of compliance to meet the requirements should be obtained consistently.
The visit date for the audit should be scheduled in agreement with the certification applicant.
6.2.3.2.2 The initial audit should be conducted in the essential production process to cover all
phases of product project and manufacture, installation and training of personnel certification
object. It includes audit importers, holders of records and registration, certification applicants.
6.2.3.2.3 The assessment of the SGR and SGQ must be made by the OCP based on the scope of
the certification process and in accordance with the requirements of the current edition standards
ABNT NBR ISO 14971 and ABNT NBR IEC 60601-1 and ABNT NBR ISO 13485.
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6.2.3.2.4 The Brazilian OCP must conduct the initial audit of the GR and SGQ in the
manufacturing unit during the initial evaluation stage, or request that the audit is carried out by
OAC accredited by member of IAF MLA, with which OCP has MoU, through an Audit Plan
developed by the Brazilian OCP. This audit must necessarily take into account all the requirements
of Attachments A and B herein, in order to check the compliance of production and GR process.
The results of these audits should be treated and evaluated by the Brazilian OCP.
6.2.3.2.5 The certificates issued by a foreign OCP must be accompanied by a sworn translation in
Portuguese language, when they are issued in a different language other than English or Spanish.
The other documents related to the management system, which are in a different language other
than English or Spanish, must be translated into Brazilian Portuguese language.
6.2.3.2.6 During the audit, applicant manufacturer of certification shall make available to the
OCP all documents related to certification of SGR and SGQ and present the records of the
production process which clearly contain the identification of the object of certification. The OCP
must analyze the documentation to ensure that the requirements described in Attachments A and B
of this RAC have been complied with. For the audit of importers, holders of records and
registration, certification applicants, the OCP must analyze the documentation to ensure that the
requirements described in Attachment B of this RAC have been complied with.
6.2.3.2.7 During the audit, the manufacturer shall provide, where available, copies of the reports
to evaluate items ABNT NBR ISO 14971 and ABNT NBR IEC 60601-1 of Attachment A and
of ABNT NBR ISO 13485:2004, of Attachment B, rom any other evaluation system,
audits/inspections of SGR and SGQ, and the corrective actions that have been implemented when
identified and applicable.
6.2.3.2.8 If there is a need to include new products and/or accessories within the already certified
product family, after the initial audit, the OCP should check whether or not a special audit, if the
initial audit has not covered all manufacturing steps, is needed for new products.
6.2.3.2.9 OPC, after audit, shall issue report, registering the result thereof, having this RAC as
reference.
6.2.3.2.10 The audit report must be signed by, at least, the audit team, provided that a copy shall
be available to the certification applicant.
6.2.3.2.11 Any changes in the productive process must be informed to OCP and may imply, if
affecting the compliance of product, a new audit
6.2.3.2.12 In case of certification based on “pilot unit”, it is incumbent upon OCP, during the audit,
to ensure that the product manufacture in scale corresponds to the tested “pilot unit”.
6.2.3.3.13 Assessment of Manufacturer’ SGQ

The manufacturer’ SGQ must be assessed:
a) According to ABNT NBR ISO 13485:2004, verifying the requirements set forth in
Attachment B herein; or
b) Through analysis of last audit report, of requirements set forth in Attachment B, provided
that such Audit report encompasses the product production line subject matter to certification
for certified companies, with valid certificates issued by OAC accredited by Inmetro in
compliance with ABNT NBR ISO; or
c) Through compliance analysis of last audit report of requirements included in Attachment B, as
set forth in RDC/ANVISA No. 16/2003 “Certification of Good Manufacturing Practices and
Control” for certified companies, with valid certificate issued by Anvisa. During the analysis, it
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shall be respected the assessment criteria of activities of table 10 of Attachment B – Assessment
Criteria of Compliance of Activities according to RDC Anvisa 16/2013.
6.2.3.3.14 The audit of AGR shall:

a) Confirm the compliance with the requirements described in Attachment A;
and
b) Assess the procedures that the legal manufacture has in force for RMP and RHProj.
6.2.4 Definition of Test Plan

It applies to the requirement 6.2.4 of RGCP, in full.
6.2.4.1 Definition of Tests to be performed

It applies to the requirement 6.2.4.1 of RGCP with the following text:
The Test Plan should be set initially by the manufacturer and OCP, observing the rules of ANVISA
Normative Ruling in force subsequently undergoing critical laboratory analysis for implementation
of the budget, meeting the following requirements:
6.2.4.1.1 In this phase the OCP should analyze the consistency of the documentation submitted by
the applicant in item 6.2.3 for the preparation of the product Tests Plan defined by the risk
management map.
6.2.4.1.2 The Test Plan should be consolidated between OCP and the laboratory, before the start of
the tests, according to the following requirements:
a) The laboratory must interact with the PCP, in case of doubts about conducting the tests in the
definition stage of the tests to be performed.
b) There must be interaction between OCP and the laboratory to enable and facilitate the execution
of the tests or if required a modification of the Initial Test Plan.
6.2.4.1.3 The laboratory shall confirm and list in the test report all the received documentation
necessary to the performance of tests, listed in item 6.2.1, as well as indicate its versions, whenever
applicable.
6.2.4.1.4 During the execution of the tests, the laboratory may question and request OCP to review
the test plan and submitted documentation.
6.2.4.1.5 The type test shall be fully performed in the pilot unit or in sample of production line of
equipment under certification process.
6.2.4.1.6 The test report issue shall not exceed two (2) years as of the acceptance date of
contraction of OCP for product certification.
6.2.4.1.7 For large equipment, according to definition of item 4.7, the issue of the test report
cannot exceed four (4) years from the date of the acceptance of contraction of OCP for certification
of product.
6.2.4.1.8 May be accepted, in the initial assessment, that meet test reports, at least the requirements
of clause 6 of this RAC, since:
a) All changes made in the project are properly documented and the relevant tests carried out and
also documented;
b) If there have been no significant changes in the project, in accordance with paragraph A1 of
Attachment A of this RAC, since the issuance of the reports, the applicant must submit document
stating that after the date of issue of the test report the product has not been changed; and
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c) The assessment of the testing performed of initial project equipment and product risk
management for which the report was issued, the date the equipment project and statement of item
6.2.4.1.8.b must integrate the certification process documentation of equipment.
6.2.4.1.9 The planning of type tests on collected samples of the product should be carried out by
OCP after evaluation of the documents listed in item 6.2.3 and the analysis of test reports carried
out previously, submitted by the applicant, which must comply with technical standards applicable
listed in item 3 of this RAC and in IN Anvisa in force and requirements of RGCP complemented by
this RAC.
The type tests should be repeated by evaluating the OCP of impact of changes in the mechanical or
electrical-electronic project, or changes to critical components, items 4.8 and 4.9 of the standard
ABNT NBR IEC 60601-1 of the product materials list originally certified made by the
manufacturer, where such assessment concludes that the revisions or changes impacting on
previously assessed accordingly. It should also be repeated the type tests by determination of
Anvisa or at the time of recertification of the product and project, with technical justification for
such an achievement.
6.2.4.2 Sampling Definition

It applies to the requirement 6.2.4.2 of RGCP with the following changes:
“In order to perform the initial tests of evaluation of the product, the sample should be collected by
the OCP or by agreement between the parties, sent to the OCP by the manufacturer. The sample
must consist of one (1) unit of production line of products already inspected, released and packed
for marketing or one (1) pilot unit. The OCP or manufacturer, respectively, should develop
sampling report, detailing the following information: date of dispatch of the sample, the place of
manufacture, storage conditions, sample identification (model/brand, batch number and date of
manufacture).”;
6.2.4.2.1 In order to achieve the product recertification tests, the sample should be collected by the
OCP or by agreement between the parties, sent to the laboratory under the supervision of OCP by
the manufacturer. The sample must consist of one (1) unit of production line of products already
inspected, released and packaged for sale. The OCP must prepare the sample report, detailing the
following information: date and place of manufacture, storage conditions, sample identification
(model, brand, batch number, software version, when applicable, and date of manufacture);
6.2.4.2.2 The manufacturer, as agreed with the CFP, must control all characteristics of the sample
before sending it to the laboratory;
6.2.4.2.3 In order to recertification, or when non-compliance is identified during the audit of

maintenance, the OCP should control all characteristics of the sample to be sent to the laboratory;
6.2.4.2.5 If OCP deems necessary the assessment of more than one (1) sample, the amount of
samples, acceptance/rejection criteria and exceptional cases must be negotiated with the
manufacturer for a number greater to or equal than three (3) samples;
6.2.4.2.6 Note 1 is applicable in initial assessment of product;
6.2.4.2.7 Note 2 is fully applicable; and
6.2.4.2.8 Note 3 is fully excluded.
6.2.4.2.9 If the OCP or manufacturer deem necessary, under an agreement negotiated between the
parties, the assessment of more than (1) a sample, the number of samples, acceptance/rejection
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criteria and exceptional cases should include a number greater than or equal or multiple of (3)
samples and all samples taken from the same production batch. In this case apply in full the
following requirements RGCP:
a) the Table 4; and
b) i t em 6.2.4.2.1.
6.2.4.2.10 The requirement 6.2.4.2.2 of RGCP is completely excluded.
6.2.4.2.11 The requirements 6.2.4.2.3 and 6.2.4.2.4 of RGCP are applicable replacing the term
“Prototype” by “Pilot Production Unit” as defined in requirement 4.22 of this RAC.
6.2.4.2.12 The OCP must verify compliance and the evaluation by the manufacturer or laboratory
tests of all applicable regulatory requirements;
6.2.4.2.13 The manufacturer shall demonstrate to the OCP, through photos, diagrams and other
means to ensure, unequivocally, that the sample meets the characteristics defined by the OCP.
6.2.4.2.14 The collection of samples, for family, should be carried out in accordance with
Attachment D of this RAC, selecting the model most critical configuration.
6.2.4.2.15 The approval of pilot unit in initial tests does not exempt OCP from validating the
products after start of production line operation.
6.2.4.2.16 The tests should be performed with collected sample(s).
6.2.4.2.17 Upon failure of the sample in the tests, the non-compliance shall be notified to the
applicant. If the applicant does not technically challenging the non-compliance, this step will be
suspended and the applicant must submit a plan of treatment and exclusion of non-compliance
observed for the resumption of trials defined as required by the OCP, from the analysis of the
corrective action manufacturer. The date for the resumption of initial tests will be agreed between
the applicant, OCP and laboratory.
6.2.4.2.18 Upon failure of tests, and depending on the assessment of OCP, the sample should be
deemed failed, and a new sample should be forwarded by the manufacturer to the laboratory. OCP
should control all features of new samples.
6.2.4.3 Laboratory Definition

For purposes of this RACT, the criteria of Laboratory Definition should follow the requirements of
RGCP, as stated or modified herein:
6.2.4.3.1 It applies to the requirement 6.2.4.3.1 of RGCP, in full.
6.2.4.3.2 It applies to the requirement 6.2.4.3.2 of RGCP with the following changes:
a) Item “a” and Notes 1, 2, 3 and 4 shall be fully applied;
b) Item “b” shall be fully excluded, being replaced by the following text:
“When the laboratory(ies) accredited by Inmetro/Cgcre or signatory of mutual recognition
agreements ILAC or IAAC, fully in the specific scope does not comply with, at most, four (4)
months the deadline for the start of the tests described in RAC from the contract signing, in
exceptional and precarious, the OCP can be used laboratories in accordance with the requirement of
6.2.4.3.1 of RGCP. For large size equipment as defined 4.7, this period extends to a maximum of
six (6) months.
c) Item “c” is completely excluded; and
d) The laboratory of third-party accredited has the prerogative of performing external local texts
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regarding the physical location of laboratory, provided that clearly described in accreditation scope
its condition of accredited for performance of tests in external facilities to the laboratory.
6.2.4.3.3 The requirement 6.2.4.3.3 of RGCP is fully applied.
“In any case of laboratory use of 1st party accredited in the scope of specific test, in whole or in
part, the OCP should witness, record the execution of all tests, including monitoring of selection
and sample preparation step and making results”.
“In any case of use of laboratory of 1st or 3rd party accredited for another scope test, the OCP
should, after acknowledge and document the training and infrastructure (including equipment) lab,
witness, record the execution of all tests, including monitoring the selection step and preparation of
the samples and results outlet”.
6.2.4.3.6 The requirement 6.2.4.3.6 of RGCP is fully applied, adding the following text:
“In order to comply with formal verification requirement of experience, professional OCP must
have record of participation at least three (3) audits in the past three consecutive years, in standard
ABNT NBR ISO/IEC 17025:2005 and evidence of knowledge, training and experience in the trial
to be evaluated and the product being tested. Formal training of audit in the standard ABNT NBR
ISO/IEC 17025:2005 should be administered by an independent organization OCP.”
6.2.4.3.7 The requirement 6.2.4.3.7. of RGCP is fully applied.
6.2.4.3.8 If a single laboratory is not able to perform all the tests prescribed more than one
laboratory can be used, complying with the requirements for RGCP lab selection complemented by
this RAC.
6.2.5 Treatment noncompliance in the Initial Assessment step

It is completely applied the requirement 6.2.5 and item “Treatment of Noncompliance in the initial
Assessment Stage” of RGCP.
6.2.6 Issue of Compliance Certificate

The issuance of the Certificate of Compliance must follow the conditions described in RGCP and
must be performed by family of equipment under sanitary surveillance regime, as provided in
Attachment D of this RAC.
6.2.6.1 Critical Analysis and Certificate Decision

It is completely applied the requirement 6.2.6.1. and items “Critical Analysis and Certificate
Decision” of RGCP complemented by the following requirements:
6.2.6.1.1 In the case of digital sphygmomanometers certification and digital clinical thermometers,
which must meet metrological regulation, the certificate of compliance shall only be granted to the
applicant after obtaining the Model Approval Order issued by Inmetro.
6.2.6.1.2 Product testing reports for service of metrological requirements may be used in the
certification process of this RAC if duplicate any specific requirement of compliance assessment.
6.2.6.1.3 The Compliance Certificate will be valid for five (5) years, as of its issue.
6.2.6.2 Certificate Issue

It is completely applied the requirement 6.2.6.2 “Certificate Issue” of RGCP.
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6.2.6.2.1 It is completely applied the requirement 6.2.6.2.1 and 6.2.6.2.2 of RGCP.
6.2.6.3 Compliance Issue

It is completely applied the requirement 6.2.6.3 “Compliance Issue” of RGCP.
6.2.6.3.1It applies to the requirement 6.2.6.3.1 of RGCP according to items below:

a) it is completely applied the items “a”, “d”, “e”, “g”, “l” and “n” and Notes 1 and 2; (specific to
sphygmomanometers and digital thermometers)
a) item “b” is fully applied replacing the term “applicant supplier” for “applicant”, as definition
4.20 herein;
b) The item “c” is fully applied, replacing the term “manufacturer” for “manufacturer, contract
manufacturer and/or legal manufacturer, where applicable”, respectively according to definitions
4.8., 4.9. and 4.10 of this RAC;
c) it is completely applied the item “f” indicating “Model 5”;
d) it is completely applied the item “h” supplemented with information on the original features of
the product;
e) It is completely excluded the item “i” and “j”;
f) it is completely applied the item “k” complemented by the identification of technical standards
applied for the certification;
g) it is completely applied the item “m” complementing the date information of issue date(s) of test
report(s);
h) inform the date of acceptance of the proposal, when the date of the test report is issued for more
than two years or four years for large equipment, as defined in item 4.7 on the date of Certificate
Issue;
i) inform the list of tested accessories and parts in conjunction with the product;
j) inform the version of the user manual and product design evaluated for granting certification;
and
k) inform the rated version of software for equipment with embedded software or accompanying.
6.3 Maintenance Assessment

Maintenance Assessment should be carried out by OCP as the conditions set by RGCP in Annexes
A and B of the RAC. Excluded from this RAC Notes 1, 2 and 3 of requirement 6.3 of RGCP.
6.3.1 Maintenance Audit of Quality Management System, Risk Management and

Manufacturer Production Process.
The audit of maintenance should be performed by the OCP, as the conditions of RGCP and in
Attachments A and B of the RAC with the following changes:
6.3.1.1 It applies to the requirement 6.3.1.1 of RGCP replaced by:
6.3.1.1.1 The OCP must schedule periodical maintenance audit in the production process of the
manufacturer or service provider covering at least the following steps:
a) verification of the original documents referred to in item 6.2.1, in particular with regard to
their availability, organization and retrieval;
b) analysis of records, especially those related to compliance with the requirements for
conducting audits listed in Attachments A and B of this RAC; e
c) OCP shall assess the auditing firms with production process considered essential to the
manufacture of the product object of this certification, if these companies adopt a quality
management system certified in accordance with the standard ABNT NBR ISO 13485:2004 or
RDC Anvisa No. 16/2013 “Certificate of Good Manufacturing Practices and Control”:
i) the last audit report on the subject product of this certification covers the requirements of
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Attachment B and that they are in compliance with;
ii) that in both cases the certificate is valid; and
iii) that the general items of Attachment A of that verification RAC
have been met.
6.3.1.2 It applies to the requirement 6.3.1.2 of RGCP replacing the term “Inmetro/Dconf”
for “Anvisa”;
6.3.1.3 The OCP must witness the performance of routine testing on the production line where
applicable.
6.3.1.3.1 The audit shall be made in agreement between the OCP and the manufacturer. The OCP
must program the factory audit for the period in which the production line is producing.
6.3.1.3.2 The OCP must witness operation of the production line and the realization of functional
tests and routine, when applicable, as scheduled, recording the serial number and model of the
product assessed in onsite trials.
6.3.1.4 If the OCP is not possible to witness the assembly line operation even during maintenance
audit, OCP must schedule a special audit to be held in the week that the assembly line production is
restarted.
6.3.1.5 Since there is evidence that the warrant or statement of Anvisa, the OCP can hold special
maintenance audits and type tests to check the maintenance of compliance of certified products.
6.3.1.6 The frequency of maintenance audits cannot be greater than fifteen (15) months from the
date of Certificate Issue;
6.3.2 Maintenance Tests Plan

It applies to the requirement 6.3.2 of RGCP supplemented and modified below. The establishment
of Maintenance Testing Plan may occur by determining the OCP, based on the audit in accordance
with Attachment A, due to design changes or rules requiring new tests, or by determination of
Anvisa. Under these conditions the Maintenance Testing Plan must follow the requirements of
RGCP complemented by that RAC.
Note 1: Maintenance Testing Plan is not applied to factory routine tests, previously agreed between
OCP and manufacturer, in accordance with the AGR and Attachments A and B of the RAC where
applicable.
6.3.2.1 Definition of tests to be performed

Maintenance tests should be performed according to the requirements of item 6.2.4.1 of RGCP,
observing ANVISA Normative Ruling in force complemented by this RAC.
6.3.2.2 Maintenance Sampling Definition

The criteria for Definition of Maintenance Assessment Sampling should follow, along with the
requirements set out in RGCP the following requirements:
6.3.2.2.1 The collection of samples, per family, in accordance with Attachment D of this RAC,
should include the model most critical configuration.
6.3.2.2.2 The minimum of one (1) sample must be collected from the production line, by random
selection performed by the OCP products already inspected, and packaged for commercialization
released.
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6.3.2.3 Lab definition
The Lab Defining criteria, if identified changes in the product during the certification maintenance
audit should follow, along with the requirements of RGCP, the same requirements of item 6.2.4.3 of
this RAC.
6.3.3 Treatment of noncompliance in the Maintenance step

The criteria for the treatment of non-compliance in the maintenance stage must follow the
requirements of RGCP, complemented by instructions of this RAC.
6.3.3.1 In the event of failure during the course trials of item 6.3.2.1, Compliance Issue will be
suspended until evidence of the applicant, in a new audit, when it will be carried out new sampling
and new tests, elimination of non-compliance. The new audit will take place within a period not
exceeding fifteen (15) days.
6.3.3.2 If the sample failure occurs during the tests, the non-compliance shall be notified to the
applicant and the Compliance Issue will be suspended. If the applicant does not technically
challenging the non-compliance within 15 days, the applicant must submit a plan of treatment and
remedy of non-compliance observed for the resumption of tests defined as required by the OCP,
from the analysis of the corrective action manufacturer. New sample shall be taken in accordance
with the requirement 6.3.2.2 of this RAC and new tests performed.
6.3.3.3 The failed products in the possession of the applicant, shall be canceled by the
manufacturer with accompanying OCP, unless it is possible the reprocessing.
6.3.3.3.1 The decision must be properly grounded to ensure that they are not placed on the non-
conforming market products or with compromised safety.
6.3.3.4 If noncompliance verified during the maintenance tests are remedied, the OCP must assess
the need for performing new tests according to item 6.2.5 of this RAC.
6.3.3.5 OCP shall inform Anvisa, through e-mail [email protected] regarding

the noncompliance identified in the certification maintenance process, which require a field action
or recall, whenever there are enough evidences or proves that a health product does not comply with
the main requirements of safety and efficacy applicable. The following product and issue data
identified must be included in email:
a) description of the problem;
b) trade name and model of the product;
c) lots/series at risk;
d) registration number at Anvisa;
e) name of the holder applicant of the certificate;
f) The risk related to the use of the product; and
g) corrective actions related to the product/problem.
6.3.3.6 Products not subject to repair and not conforming must be collected and destroyed with the
accompaniment of the OCP. In the event the product is repaired, the same after repair, must
undergo all the necessary tests to finished product release to assess whether the non-compliance was
properly cleared.
6.3.4 Maintenance Confirmation

The criteria for confirmation of the maintenance must follow the requirements of RGCP,
complemented by instructions of this RAC.
6.3.4.1 OCP should inform about the cancellation or suspension of the certificate to ANVISA
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through email [email protected] including the following information:
a) Certificate number and number of OCP
b) applicant's name
c) Brand and model of the product.
d) Anvisa registration number
e) An account of the reason for the cancellation or suspension, with the report number if applicable.
6.4 Recertification Assessment

At the end of the period of five (5) years from the Issue Certificate of Compliance, the criteria for
the assessment of recertification must follow the requirements of RGCP, complemented by
instructions applied in items 6.2.3 “Analysis of Risk Management File” 6.2.5 “Testing Plan Initial”
6.2.4.2 “Setting Sampling” and 6.2.4.3 “lab setting” of this RAC.
6.4.1 The complete type tests should be repeated with respect to the following situations:
a) Test reports can be accepted up to two (2) years from the date of acceptance of the
recertification when there occur the conditions set forth in items (b), (c) or (d). For large equipment
as defined in item 4.7, the term for the date of issue of the test report extends to four (4) years. The
deadlines apply on the date of signing of the OCP accepted for recertification of the product;
b) Change in the review of any technical standard of the current Instruction used in the initial test
affecting the results of the tests carried out previously;
c) changes in the structure of the equipment that implies changes in the product with the previously
assessed compliance; and
d) As requested by Anvisa.
6.4.2 OCP must inform ANVISA through [email protected] email about the
non-conformities identified in the recertification, requiring a playing field or recall where there is
sufficient evidence or proof that a product for health does not meet the essential requirements of
applicable safety and efficacy. Using the item requirements 6.3.3.5.
7 CLAIMS TREATMENT
The criteria for dealing with complaints must follow the requirements of RGCP complemented by
this RAC.
7.1 It applies to the requirement 7, “Claims Treatment”, of RGCP, in full complemented by this
RAC:
7.2 OCP should perform audits with a maximum interval of 15 months, the applicant made to
assess the requirement 7 of RGCP; and
7.3 The applicant must ensure forwarding complaints to the manufacturer and the answers to the
same customer manufacturer;
7.4 The applicant must have a dealing with complaints that includes the requirement 7 RGCP,
expressed as Complaint Treatment Policy signed by its largest business.
8 ACTIVITIES PERFORMED BY OCP ACCREDITED BY MEMBER OF IAF MILA

The criterion “Activities Performed by OCP accredited by member of the IAF MLA” must follow
the requirements of RGCP.
8.1 It applies to the requirement 8 “Activities Performed by OCP accredited by member of the IAF
MLA” of RGCP, in full.
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9 CERTIFICATION TRANSFERENCE
The criterion “Certification Transference” must follow the requirements of RGCP.
9.1 It applies to the requirement 9, “Certification Transference”, of RGCP, in full
complemented by the understanding between OCP LIABILITY Limit OCP emitted by the activity of
the receptor.
10 TERMINATION OF CERTIFICATION
The criteria for Certification Termination must follow the requirements of RGCP, complemented by
instructions of this RAC.
10.1 It applies to the requirement 10.1 of RGCP, in full.
10.2 It applies to the requirement 10.2 of RGCP, in full complemented by:
10.2.1 The collection of samples and the realization of the process of closing assays can be
performed in accordance with Attachment A of this RAC at the discretion of OCP.
10.2.2 For equipment EM and large EM systems, it is not necessary to collect samples and closing
tests. The OCP should assess the latest records accompanying test performed by the manufacturer
responsible for the supply chain.
10.6 It applies to the requirement 10.5 of RGCP, in full complemented by:
10.6.1 The OCP shall notify the termination of the certification Anvisa via email
[email protected] with the following information:
a) certificate number and OCP number;
b) applicant's name;
c) brand and model of the product; and
d) Anvisa registration number.
e) attaching the reason for the termination.
10.7 It applies to the requirement 10.7 of RGCP, in in full complemented by:
10.7.1 The results of the audit, testing and closing records should be documented to integrate the
product certification process documentation and must be kept by the OCP in electronic media or
other until at least five years of certification of the closing date.
11 COMPLIANCE IDENTIFICATION TAG

The criterion “Compliance Identification Tag” must follow the requirements of RGCP,
complemented by instructions of this RAC:
11.2 It applies to the requirement 11.2 of RGCP replacing it by the following text:
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“The Compliance Identification Tag can be printed on Compliance Issue, and must be marked or
affixed to the product and/or printed or attached to the packaging, in accordance with the
instructions set out in Attachment C, Compliance Identification Tag, of this RAC”.
11.3 It applies to the requirement 11.3 of RGCP replacing it by the following text:
“For imported products, the Compliance Identification Tag shall be marked or affixed to the
product and/or printed or attached to the packaging, in accordance with the instructions set out in
Attachment C, Compliance Identification Seal, of this RAC, before the entry of the same in the
country”.
11.4 Specification
The specification of Compliance Identification Tag is defined in Attachment C herein.
11.5 Traceability
The applicant must implement a control for the traceability of products bearing the Compliance
Identification Tag, should this control be available to Inmetro and Anvisa for a period of time
equivalent to the expected useful life of the product, but in no case for less five (5) years from the
date of commercial distribution by the manufacturer. The OCP should check the implementation of
this control as well as the effectiveness of product traceability certificates.
12 AUTHORIZATION FOR USE OF COMPLIANCE IDENTIFICATION TAG

The criterion “Authorization for Use of Compliance Identification Tag” must follow the
requirements of RGCP.
12.1 It applies to the requirement 12, “Authorization for Use of Compliance Identification Tag”, of
RGCP, in full.
13 – RESPONSIBILITIES AND OBLIGATIONS

The criterion “Responsibilities and Obligations” must follow the requirements of RGCP, replacing
the term “in particular RAC object” by “this RAC”; replacing the term “specific RAC object” by
“this RAC”; and complementing the requirement as the following text:
13.1 Obligations of Holding Applicant of Certificate. The applicant must:
13.1.1 Only produce, import and market the object of certification products, which comply with this
RAC and as evidenced by Compliance Issue.
13.1.2 It is fully applied the requirements of 13.1.2, 13.1.3, 13.1.4, 13.1.5, 13.1.6, 13.1.7, 13.1.8,
13.1.9, 13.1.10, 13.1.17, 13.1.18, 13.1.19 and 13.1.20 of RGCP.
13.1.3 It is fully excluded the requirement 13.1.11 and 13.1.15 of RGCP.
13.1.4 It applies to the requirement 13.1.12 do RGCP with the following text:
“Announcing the field of action or recall of certified products with non-compliance, do it according
to the rules of Anvisa RDC No. 23 of 2012 or its substitute.”
13.1.5 The requirement 13.1.13 of RGCP is replaced with the following wording:
“13.1.13.1 Report to Anvisa, according to the timetable in accordance with ANVISA RDC No. 67
Resolution of December 21, 2009, or its substitute, when identifying the certificate object
distributed on the market have non-conformities, which put at risk the health or safety the
consumer, after the knowledge of the following events that occur in the country associated with the
19
medical device certificate and Anvisa registration on its behalf:
a) death, serious threat to public health and counterfeit.
b) serious adverse event, with no associated deaths; and no serious adverse events whose recurrence
has the potential to cause serious adverse event in a patient, user or other person.
13.1.13.2 Report to Anvisa, according to the timetable in accordance with ANVISA RDC No. 67
Resolution of December 21, 2009, or its substitute, after technical defect observed in the country
associated with the medical device certificate and Anvisa registration on its behalf, that may lead to
serious adverse event in a patient, user or other person, provided that at least one of the following
conditions is verified:
a) the possibility of technical defect of recurrence is not remote;
b) an instance of the same type has caused or contributed to death or serious harm to
health in the past two years;
c) the product registration holder needs to take action to prevent a health hazard;
d) there is possibility of error induced use by design, labeling or poor instructions.
13.1.13.3 Report to Anvisa, according to the timetable in accordance with ANVISA RDC No. 23
Resolution of April 4, 2012, or its substitute, for notification of the completion of field action
involving products for the health of its responsibility, in accordance with the following conditions:
I - in case of need to use the mass circulation of media vehicle for the dissemination of the alert
message;
II – In case of hazard to public health;
III When identified occurrence risks of serious adverse event and the situation does not frame by
subsections I or II of Article 9th of RDC No. 23/2012.”
13.1.6 The requirements 13.1.14 and 13.1.16 are fully applied replacing the term “Inmetro” for
“Inmetro and Anvisa”.
13.1.7 in case of need to use the mass circulation of the media vehicle for the dissemination of the
alert message:
13.1.7.1 Ensure the achievement of routine tests on products, as Attachment A, 100% of the
manufactured units.
13.1.7.2 Perform tests according to item 6.2.4. as established by Anvisa or Inmetro to evidence
the compliance maintenance of certified products.
13.1.7.3 Ensure that the RMP and RHProj are kept updated at any time certification under
penalty of suspension or withdrawal of certification in the case of breach of this requirement.
13.1.7.4 Ensure, in the case of digital sphygmomanometers and digital clinical thermometers,
maintaining the same conditions of the type approval of Ordinance where such product is subject to
certification/maintenance/recertification. There is change in the product to meet the requirements
approved herein, this must be submitted to a new technical assessment model of the Directorate of
Legal Metrology – Dimel, via e-mail [email protected], regardless of the impact analysis,
which needed to be made in the pilot unit for approval requirements in this RAC.
13.1.7.5 Meet the other legal requirements for the manufacture, import and marketing of the
product, under penalty of suspension or cancellation of certificate.
13.2 Obligations of OCP. OCP must:
13.2.2 It is fully applied the requirements 13.2.1, 13.2.2, 13.2.3, 13.2.4, 13.2.5, 13.2.6, 13.2.8,
20
13.2.9, 13.2.12, 13.2.13, 13.2.14, 13.2.16 and 13.2.17 of RGCP.
13.2.3 It applies to the requirement 13.2.7 of RGCP being replaced by the following text "Collect,
when applicable for determination of Anvisa, before suspicions or duly substantiated complaints,
samples for defined essays in this RAC, bearing the costs related to collection and testing,
observing the provisions of item 14 of this RAC.”
13.2.4 It is completely applied the requirement 13.2.10 do RGCP replacing the term “Inmetro” by
“Inmetro and Anvisa”.
13.2.5 It is completely applied the requirement 13.2.11 of RGCP, replacing the term
“Inmetro/Cgcre” for “Anvisa”; and the term “ABNT NBR ISO 9001 or ISO 9001” by “ABNT NBR
ISO 13485:2004 or Anvisa RDC No. 16/2003 Good Manufacturing Practices”
13.2.6 It is completely applied the requirement 13.2.15 of RGCP replacing the term
“Inmetro/Dconf” by “Inmetro/Dconf and to Anvisa”;
13.2.7 In complement to RGCP, OCP must:
13.2.7.1 For digital sphygmomanometers and digital clinical thermometers when such a product
remains unchanged under the conditions mentioned in the type approval of Ordinance during
certification / maintenance / recertification, request the applicant to submit the product to new
technical assessment model to Metrology Directorate Legal - Dimel, via e-mail
[email protected], regardless of the impact analysis, which needed to be made in the pilot unit
for approval to the requirements of this RAC.
13.2.7.2 Accept any penalties imposed by the regulators of the product.
13.2.7.3 Inform the applicant about requirements established by Inmetro and Anvisa that the
impact.
13.2.7.4 Maintain, on the website of Inmetro, the relationship of all certificates issued, allowing
the full reading of the texts and information regarding these certificates, or through consultations
extracted reporting database containing all information contained in certificates issued.
13.2.7.5 Accept any penalties imposed by the regulators of the product.
13.2.7.6 Convey to the applicant the requirements established by Inmetro and Anvisa that the
impact.
13.2.7.7 Maintain, on the website of Inmetro, the relationship of all certificates issued, allowing
the full reading of the texts and information regarding these certificates, or through consultations
extracted reporting database containing all information contained in certificates issued.
14 MARKETING MONITORING
The criteria for monitoring the market is incumbent upon Anvisa, being established by
regulations of that agency for the under Health Surveillance Equipment.
14.1 Metrological equipment, digital electronic sphygmomanometers (Inmetro Ordinance No.

96/2008 as amended), and digital clinical thermometers (Inmetro Ordinance No. 89/2006 as
amended) are the responsibility of Anvisa and Inmetro/Dimel.
21
15 PENALTIES
The criteria for application of penalties should follow the requirements of RGCP complemented by
this RAC.
15.1 The applicant who fails to meet the requirements of this RAC, is subject to suspension and
cancellation of certification penalties, defined and operationalized as the certification scheme
Inmetro.
15.2 For products subject to registration and registration at Anvisa, the requesting company that
fails to meet the requirements of this RAC, the appropriate items, is subject to the penalties
described in Law no. 6437/77 and art. 273 of the Brazilian Penal Code - Law No. 2848/40 and
offenses subject to penalties will be considered, among others:
15.2.1 Provide products outside of quality standards to the Compliance Identification Tag established
in this RAC;
15.2.2 Using Compliance Identification Tag in products not bearing the certification;
15.2.3 Not to inform or provide perjury regarding the certified products;
15.2.4 Prevent the access of auditors do documents and registration of its system; and
15.2.5 Not accept the verification and collection within the terms set forth herein.
15.3 The noncompliance of requirements applicable in this RAC, by the requesting company,
which the products are not subject to registration and enrollment in Anvisa, grants sanitary breach,
according to Law No. 6437, dated August 20, 1977 and article 273 of Brazilian Penal Code – Law
No. 2848/40, without prejudice the civil, administrative and criminal penalties applicable, including
those set forth by Law No. 8078, dated September 11, 1990.
16 DENOUNCES
It is completely applied the requirement 16 “Denounces” of RGCP.
22
ATTACHMENT A – AUDIT
A.1 The factory audits must be performed in compliance with requirements of table 1.
1. It shall be used as a basis for evaluating the risk management file. The AGR must demonstrate
that no change affecting the relevant product safety unmet by control measures. The requirements
of Tables 2, 3, 4, 5, 6 and 7 must be audited and for this purpose may be used electronic means and
tools for assessing the document compliance.
A.2 In initial certification audit, it will be inspected the documents to be used in production.
1. Statistical data of production for manufacturers in Brazil, or foreign producers who are starting
production of the object of certification may be available only during the first audit of maintenance
or in the event of an extraordinary audit before it.
2. Statistic date of production for foreign manufactures already producing the subject matter of this
certification must be verified in Initial Factory Audit.
Table 1 – General Requirements of Compliance Assessment

Risk management application to products for health
Assessment Requirements of Audit Compliance.
1 General Requirements of Compliance Assessment in Audit.

The Brazilian OCP should audit the GR and QMS in the plant or to request that the audit be carried
out by CABs accredited by MLA member body of IAF, with which OCP has MoU through an Audit
Plan developed by the Brazilian OCP. This audit must necessarily take into account all the
requirements of Annexes A and B, in order to check the conformity of production and GR process.
The results of these audits should be treated and evaluated by the Brazilian OCP
2 The OCP should evaluate the Risk Management File (AGR) and in accordance with the
requirements of this RAC and the following standards:
2.1 ABNT NBR ISO 14971/2009, Health products, risk management application to health
products (Table 2)
2.2 ABNT NBR IEC 60601-1/2010, Medical Electrical Equipment Part 1, General requirements
for basic and essential performance security, section 14, Medical Electrical Systems Programmable,
corrected version 2013 (Table 3)
2.3 ABNT NBR IEC 60601-1-6/2011, Medical Electrical Equipment, Part 1-6 General requirements
for basic safety and essential performance, Collateral standard, Usability, corrected version 2013
(Table 4).
2.4 ABNT NBR IEC 62366, Health products, Application Usability Engineering to health
products (Table 5)
2.5 Verification items of Standard ABNT NBR IEC 60601-1-9/2010 or Risk Management
2.6 IEC 62304/2006, Medical Electrical equipment, software and lifecycle of healthcare software
process (Table 7).
3. OCP should check through the AGR analysis of the requirements of Tables 2, 3, 4, 5, 6 and 7 in
the RAC in order to identify if there was no change in the product or technical standard that impacts
product safety and that has not been evaluated by laboratory test.
23
3.1 The OCP should check RHProj and RMP changes that imply the need to conduct new type tests
according to item 6.2.4 of this RAC.
4. The OCP must witness the complete manufacturing, assembly line and check the RHP, of a
product, in order to ensure there are no processes or process changes not documented in the AGR.
Where certification is per family, the selected model should be the most critical configuration of the
certified product.
4.1. The OCP must witness the realization of routine tests on the assembly line, provided by the
manufacturer, in accordance with the AGR product, registering the model and product serial number
tested in the audit report. The selection of the sample for testing should follow the guidance of item
6.2.6 of this RAC.
5. The inspection of the plant documentation must demonstrate that routine tests are applied to
100% of the units produced to confirm the operation (essential performance) correct product and
electrical safety, where applicable. The requirements that must be checked are subject to agreement
between the OCP and the manufacturer to ensure the safety of the certified product.
6. The electrical safety routine tests must prove that the product meets the sections 8.6, 8.7 and 8.8
of ABNT NBR IEC 60601-1:2010 amended version 2013 as follows:
a) grounding (section 8.6);
b) Leakage current measurement (section 8.7);
c) dielectric strength test (section 8.8, nondestructive); and
d) functional tests are specified by the manufacturer and agreed with the OCP.
6.1 For the realization of routine testing is recommended the use of the prescribed verification IEC
TR 62354:2014 General testing procedures for medical electrical equipment, routine testing in item
production line K.
7. The OCP should analyze the AGR applying all the requirements of ISO 14971 (Table 2 of this
RAC). If you identify a change technical standard or project that impacts the safety, OCP must
confirm the AGR if the product was tested again for the requirement analyzed or forms established
control measures.
8. Among the changes documented in the AGR on the analysis of the object must be related
modifications to the mechanical design, electrical design, software, installing the product, materials
and electronic components which may affect or alter the functional safety, and security the
electromagnetic compatibility (EMC) and electrical product.
9. Product samples that need to be collected for testing during a factory audit must meet the item
6.2.4.2 of this RAC.
10. The OCP shall assess the quality management system of the manufacturer and audit importers,
record holders and registration, certification of applicants in accordance with the requirements of
Annex B of the RAC. The certification in accordance with ABNT NBR ISO 13485/2004 is optional.
In the case of external certification, the certificate must be valid and the certification audit report
must ensure compliance of the items of Annex B of this RAC. The manufacturer can demonstrate
compliance with the requirements of Anvisa RDC No. 16/2013 Good Medical Products
Manufacturing Practices and Products for In Vitro Diagnostic Use.
Table 2 – The requirements for assessing the Standard ABNT NBR ISO 14971
Risk management application to health products Audit
Compliance Assessment Requirements.
Requirement Description Standard Requirement
General requirements for risk management 3
senior management responsibilities 3.2
24
personnel training 3.3

risk management plan 3.4
Risk Management file 3.5
Risk analysis 4
Process risk analysis 4.1
Use intended and identification of product safety-related characteristics for
health 4.2
Hazards identification 4.3
risk assessment for each hazardous situation 4.4
Risk assessment 5
Control risk 6
Analysis of risk control options 6.2
Implementation of risk control measures 6.3
the residual risk assessment 6.4
Analysis benefit / risk 6.5
risks arising for risk control measures 6.6
Whole risk control 6.7
Assessing the acceptability of general residual risk 7
risk management report 8
Information production and post-production 9
Table 3 - Verification Items of Standard ABNT NBR IEC 60601-1: 2010/2013

General Requirements for basic safety and main performance,
Audit Compliance Assessment Requirements.
Requirement Description Standard
Requirement
General requirements 4
Risk Management process equipment MS or MS System 4.2
Essential performance 4.3
IN equipment components 4.8
Use Component with High Integrity Feature in Equipment
4.9
Power supply 4.10
Identification, marking and documents EM equipment. 7
Marking the outside of the equipment ON or parts of EM equipment.
7.2
Marking and control instruments. 7.4
Signal safety. 7.5
Colors of the insulations of the conductors. 7.7
LEDs and switches. 7.8
Documents included. 7.9
25
Grounding for protection, functional earthling and potential equalization of

EM equipment: 8.6
Plugs and Sockets 8.6.6
equalization conductor plugs and sockets 8.6.7
leakage currents and auxiliary power through the patient 8.7
The dielectric strength test 8.8
Remarks: The manufacturer must keep records with the results of routine tests performed on 100%
of EM equipment produced in accordance with the ABNT NBR IEC 60601-1: 2010
Remark 1: Compliance is evidenced by the OCP for confirmation that the requirements of Table
3, the Standard ABNT NBR IEC 60601-1: 2010/2013.
Remark 2: The requirements of Table 3 remain unchanged through the Risk Management.
Table 4 - Verification Items of Standard ABNT NBR IEC 60601-1-6: 2011/2013

General Requirements for basic safety and main performance, Collateral Standard: Usability
of Audit Compliance Assessment Requirements.
Requirement Standard
Usability Description Requirement
1
Conditions for application to electro-medical equipment 4.1
Usability Engineering Process for electromedical equipment 4.2
Replacement of the IEC 62366 requirements 5
Table 5 - Verification Items of Standard ABNT NBR IEC 62366/2010

Application of Usability Engineering to health products
General requirements Description Requirement
4.1
The process of Usability Engineering 4.1.1
residual risk 4.1.2
for safety information 4.1.3
Usability Engineering File 4.2
effort sizing Usability Engineering 4.3
The process of Usability Engineering 5
Application Specification 5.1
frequently used functions 5.2
Identification of hazards and dangerous situations related to usability 5.3
Identifying security-related features 5.3.1
Identifying characteristics that are known hazards and situations dangerous
or foreseeable 5.3.2
primary operating functions 5.4
Specification Usability 5.5
Usability Validation Plan 5.6
26
Design and implementation of the user interface 5.7

usability check 5.8
usability validation 5.9
accompanying document 6
Training and materials for training 7
Table 6 - Verification Items of Standard ABNT NBR IEC 60601-1-9/2010 or for

Risk Management
General requirements for basic safety and essential performance, responsible eco project
Audit Compliance Assessment Requirements
Description
Identification of environmental aspects Requirement
4.1
Click to minimize environmental impact during normal use 4.5.2
Information for the end of life management 4.5.3
The evaluation of item 4.1 of conformity must be made by confirming the completion of the
activity, without the requirement of matching shares for each environmental aspect identified during
the analysis; however, compliance with item 4.1 is essential for the preparation of statements of
requirements 4.5.2 e 4.5.3.
Table 7 - Verification Items of Standard IEC 62304/2006

Software and life cycle of product process
Conformity Description Requirement
1.4
General requirements 4
quality management system 4.1
Risk management 4.2 e 4.3
software development process 5
Software Development Plan (PDS) 5.1.1
PDS maintenance update 5.1.2
maintenance of reference of the Software Development Plan and the design
and development of the current system 5.1.3
Standards, methods and software development of planning tools
5.1.4
Software integration and integration test plan 5.1.5
software verification planning 5.1.6
Planning software risk management 5.1.7
documentation of planning 5.1.8
software configuration management planning 5.1.9
Support items to be controlled 5.1.10
software configuration item control before verification 5.1.11
Analysis of software requirements 5.2
27
Definition and documentation of software system requirements 5.2.1

Content of software requirements 5.2.2
Inclusion of risk control measures in software requirements 5.2.3
Reassessment of the product risk analysis for health 5.2.4
Update System Requirements 5.2.5
Verification of software requirements 5.2.6
software architecture design 5.3
Transformation of software requirements on an architecture 5.3.1
architecture development for the interfaces of software items 5.3.2
Specification of functional and performance requirements of SOUP items 5.3.3
Specification of hardware and software systems necessary for the SOUP
item. 5.3.4
Identification of the separation needed to control risk 5.3.5
Software architecture verification 5.3.6
Detailed Software Design 5.4
software architecture improvement in software units 5.4.1
detailed design of the development of each software unit 5.4.2
detailed design or development of interfaces 5.4.3
Detailed design verification 5.4.4
Creation and verification of software unit 5.5
Creation of individual units of software 5.5.1
verification process of establishing software unit 5.5.2
Acceptance criteria software unit 5.5.3
acceptance criteria for additional software unit 5.5.4
Verification software unit 5.5.5
Software integration and integration test 5.6
Integration of software units 5.6.1
software integration verification 5.6.2
Test the integrated software 5.6.3
Content integration test 5.6.4
Verification of the integration testing procedures 5.6.5
Driving regression test 5.6.6
Content of the records of the integration test 5.6.7
Use software problem resolution processes 5.6.8
the software system test 5.7
Establishment of tests to software requirements 5.7.1
Using the software problem resolution process 5.7.2
Retesting after change 5.7.3
Verification of software system testing 5.7.4
Contents of the software system test records 5.7.5
Software release 5.8
28
the complete scan software warranty 5.8.1

Document known residual anomalies 5.8.2
Evaluation of known residual anomalies 5.8.3
release documentation versions 5.8.4
Document how the released software was created 5.8.5
end warranty of activities and tasks 5.8.6
Software Archive 5.8.7
Ensure the repeatability of the delivered software 5.8.8
software maintenance process 6
Establishment of software maintenance plan 6.1
problem analysis and modification 6.2
Documentation and evaluation of the information received from customers 6.2.1
and market of the information received about the product
Monitoring 6.2.1.1
Documentation and evaluation of the information received about the product 6.2.1.2
Assessment of the effects of the problem report on security 6.2.1.3
Using the software problem resolution process 6.2.2
Analysis of change requests 6.2.3
Approved change request 6.2.4
Communication users and regulatory bodies 6.2.5
Implementing changes 6.3
Using established procedures for implementing changes 6.3.1
modified software system Recovery 6.3.2
Process risk management software 7
software analysis contributing to dangerous situations 7.1
Identification of software items that can contribute to dangerous situations
7.1.1
potential causes of identification that contribute to danger 7.1.2
Evaluation of lists of anomalies published in SOUP 7.1.3
Potential causes documentation 7.1.4
Following the documentation of events 7.1.5
Risk control measures 7.2
Definition of risk control measures 7.2.1
risk control measures implemented in software 7.2.2
Verification of risk control measures 7.3
Check risk control measures 7.3.1
Documentation of any new sequence of events 7.3.2
documentation of traceability 7.3.3
risk management software changes 7.4
Analysis of changes in the product software for security-related health
7.4.1
29
Analysis of the impact of software changes in existing risk control measures

7.4.2
risk management activities of accomplishment with analytical basis 7.4.3
Process of software configuration management 8
configuration identification 8.1
Establishment of means of identification of configuration items 8.1.1
ID Software of Unknown Provenance - SOUP 8.1.2
Identification system configuration documentation 8.1.3
Change Control 8.2
Approval of change requests 8.2.1
Implement changes 8.2.2
Check changes 8.2.3
Creating mechanisms for tracking changes 8.2.4
configuration status accounting 8.3
Process of resolving software problems 9
Preparation of the problem report 9.1
Problem research 9.2
information communication relevant parties 9.3
Use change control processes 9.4
Maintenance of records 9.5
Problem analysis to evaluate trends 9.6
Software Problem Solving Verification 9.7
Content of the test documentation 9.8
30
ATTACHMENT B – TECHNICAL REQUIREMENTS FOR QUALITY SYSTEM

ASSESSMENT ACCORDING TO ABNT NBR ISSO 13485:2004
B-1 In the initial assessment and during maintenance audit of SGQ of manufacturer using ABNT
NBR ISO 13485:2004 for product(s) subject matter of the certification, OCP must verify
the compliance with minimum requirements related in Table 8 below:
Table 8 - Verification Items of Standard ABNT NBR ISO 13485:2004

Health Products
Quality Management System
Requirements for regulating purposes
In the assessment, initial and maintenance, of SGQ of manufacture using ABNT NBR ISO 3485:2004
or the product(s) subject matter of certification must verify the compliance with the requirements
listed below:
quality management systems Description Requirement4
General requirements 4.1
Documents control 4.2.3
Control of Records 4.2.4
Product Realization Planning 7.1
Determination of requirements related to the product 7.2.1
Review of requirements related to the product 7.2.2
Customer communication 7.2.3
Referent to item 7.2.3.c “Customers Complaint Treatment”
Design and development 7.3
Project planning and development 7.3.1
design and development input 7.3.2
design and development output 7.3.3
critical analysis and development project 7.3.4
design and development verification 7.3.5
Validation of design and development 7.3.6
Control of design and development changes 7.3.7
Verification Product Purchased 7.4.3
Control of Production and Service Provision 7.5.1
Validation of processes for production and service provision 7.5.2
Identification and traceability 7.5.3
Preservation of Product 7.5.5
Measurement and Monitoring Device Control 7.6
Process Measurement and Monitoring 8.2.3
Product Measurement and Monitoring 8.2.4
Product control nonconforming 8.3
Corrective measure
8.5.2
31
In the evaluation, initial and maintenance of the SQG importers, record holders and registration,
certification of applicants in accordance with the requirements of ISO 13485: 2004 for the product(s)
subject matter of certification the OCP is to verify compliance with the requirements listed below:
Documents control 4.2.3

Control of Records 4.2.4
Customer communication 7.2.3
Identification and traceability 7.5.3
Verification Product Purchased 7.4.3
Preservation of Product 7.5.5
Measurement and Monitoring Device Control 7.6
customer satisfaction 8.2.3
Product control nonconforming 8.3
Corrective action 8.5.2
B-2 service where applicable, should be checked in the QMS in accordance with ANVISA
Normative Ruling No. 8 of 12.26.2013, and manufacturers, according to Anvisa RDC No. 16 of
2013 or through the relevant requirements of the standard ABNT NBR ISO 13485:2004.
B.2.1 Optionally Technical Assistance, where applicable, can be performed in accordance with the
definition 4.1.1 - Technical Support - Extended Definition.
B-3 The audit of importers, record holders and registration, certification applicants must assess the quality
management system the calls to the ISO 13485 requirements: 2004, Table 8 and compliance with item 7
Complaint Handling of RGCP.
32
Table 9 – Activity Assessment Criteria of RDC Anvisa No. 16/2013

Company/Activity Requirement of CGMPC
MANUFACTURER:
I Performs all production stages: design, production / YES
assembly, quality control and distribution.
(LEGAL) MANUFACTURER:
Specifies the design and production requirements,
II YES
performs at least one stage of production (as well as
design and distribution) and subcontracts
(outsourcing) other.
CONTRACT MANUFACTURER:
YES
Holds 100% of production under specification of
III In items applicable thereto of
another company (legal manufacturer), with or
without commercial distribution. RDC No. 16/2013.
CONTRACT MANUFACTURER: YES

IV Perform the final stage of production product (final In items applicable thereto of
product, but not necessarily finished). RDC No. 16/2013.
NO
CONTRACT MANUFACTURER:
It is incumbent upon the
Performs intermediate stages of production
V legal manufacturer perform
(manufacturer of components and parts which
the necessary controls
compose a finished health product).
purchases and qualification
of suppliers.
(LEGAL) MANUFACTURER:
VI NO
Does not perform productive steps.
33
ATTACHMENT C – COMPLIANCE IDENTIFICATION TAG
C.1 In the certified product identification must contain the information set forth in this Annex as
the scope, compulsory or voluntary.
C.2 The applicant must comply with the following requirements for the use of the Compliance
Identification Tag:
a) The tag, as shown in Figure 1, can only be used in products listed in the existing IN / Anvisa
establishing technical standards, adopted for certification of conformity of Equipment under
Regime of Health Surveillance;
b) The tag, as shown in Figure 2, is applicable to Equipment not included in item C.2.a.
c) In packaging, the label must be printed or label should be used with features indelibility and
permanence, provided it meets the minimum dimensions as defined in Figure 1 and 2 of this
RAC;
d) In the product when the stamped, printed or inserted through label Compliance Identification
tag does not fit on the front of the equipment, you can use the Compliance Identification tag
depicted in Figure 3 (compulsory certification) and Figure 4 (voluntary certification).
e) In the product when the Compliance Identification tag cannot be fixed as items C.2.a, C.2.b
and C.2.d, it would not fit on the front of the equipment, it can be affixed to other parts of the
same; e
f) The black and white version can be used only in case the packaging has the same color
similar to the color seal.
C.3 The OCP must ensure that the affixing of the Compliance Identification Tag is made of
indelible, permanent and visible way as well as the possibility of Equipment under Board of Health
Surveillance be screened by sequential numbering either deliberately by the OCP in agreement with
the applicant.
34
Figure 1 - Compliance Identification tag for products with compulsory identification
Figure 2 - Compliance Identification Seal for products with voluntary certification
35
Figure 3 - Compliance Identification Seal compact for products with compulsory certification
Figure 4 - Compliance Identification Seal compact for products with voluntary certification
36
ATTACHMENT D – FAMILY FEATURE
1 - Do the products part of this family are manufactured by the same manufacturer
or manufacturing group within the same essential production process and governed
No by a single quality system?
Yes
2 – Do the products part of this family have identical operating principles?
No
Yes
3 - Do the products part of this family have the same indications, purpose or use to
which the product is intended?
No
Yes
4 - Do the products part of this family have precautions,

restrictions, warnings and similar special care?
No
Yes
5 - Do the products part of this family have similar processes and the differences
between its members do not imply changes in the risks associated with these
No
individually (risk management files)?
Yes
It does not fit as a It fits as a family of

family of equipment for equipment for health
health
37

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Ordinance No.

54/Presi, dated 02/01/2016

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE

Ordinance No. 54, dated February 1st, 2016.

THE PRESIDENT OF BRAZILIAN INSTITUTE OF METROLOGY,

Article 1st – Approve the improvement of Compliance Assessment Requirements for

National Institute of Metrology, Quality and Technology – Inmetro

LUÍS FERNANDO PANELLI CESAR

REQUIREMENTS OF COMPLIANCE ASSESSMENT FOR

1.1 GROUPING FOR CERTIFICATION PURPOSES

AGR Risk Management File

Anvisa Brazilian Health Surveillance Agency

CBPFC Certificate of Good Manufacturing Practices and Control

CNPJ National Directory of Legal Entities Reg. No.

IN Normative Instruction Anvisa

MDP Protection Means or Measures

MPO Operator Protection Means or Measures

MPP Patient Protection Means or Measures

PDS Software Development Plan

RDC Collegiate Board Resolution

RHProj Project History Record

RHP Product History Record

RMP Product Master Record

SDPD Software of Unknown Origin

SGR Risk Management Summary

It provides for the compulsory of execution and notice of field

4.1.1 Service – Extended definition [Inmetro].

4.2 Original characteristics

4.3 Critical components

4.4 Usability Engineering

4.5 Routine (or production) test

4.6 Type (or qualification) Test

4.7 Large equipment for diagnosis or therapy:

4.9 Contract Manufacturer

4.10 Legal Manufacturer

4.12 Risk Management

4.13 Normative Instruction Anvisa - IN

4.14 Master List of Quality Documents

4.15 Protection Methods

4.16 Serial or batch number

4.17 Essential productive process

4.18 Project Historic Record (RHProj)

4.19 Product Master Record (RMP)

4.21 Risk Management Summary

4.22 Pilot or Production Unit

5 COMPLIANCE ASSESSMENT MECHANISM

6 COMPLIANCE ASSESSMENT STEPS

6.1 Definition of Certification Model Used

6.2 Initial Assessment

6.2.1 Certification Request

6.2.1.1 It fully applies to the requirement 6.2.1.1 of RGCP.

6.2.1.2 It applies to the requirement 6.2.1.2 of RGCP:

6.2.1.2.2 The item “b” is applied with the following text.

6.2.1.2.3 The item “c” is completely excluded.

6.2.1.2.4 The item “e” is fully applied complemented by

6.2.1.2.9 The item “n” replaced by the following text;

6.2.1.2.10 The compliance with “o” is facultative;

6.2.1.2.11 The item “q” is excluded.

6.2.2 Request Analysis and Documentation Compliance