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DEVICE MASTER FILE

(Product Name)
(Company Name)
(Address)
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Prepared By: Signature:
Name and Designation Date :-_________________

Prepared By: Signature:

Name and Designation Date :-_________________

Prepared By: Signature:

Name and Designation Date :-_________________

TABLE OF CONTENTS
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CHAPTER TOPIC PAGE NO

1. Executive Summary
Device Description And Product Specification, Including Variants
2.
and Accessories
3. Labelling
4. Design And Manufacturing Information

5. Essential Principles Checklist

6. Risk Analysis And Control Summary

7. Verification And Validation of The Medical Device

LIST OF ANNEXURES
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ANNEXURE NO. DESCRIPTION

1. Risk Management Report
2. Clinical Report
3. Regulatory status of the similar device in India
4. EC Certificate
5. Declaration of Conformity
6. Registration Approval Certificates
7. Instruction For use
8. Structure, Drawing, Material, Specification
9. Labeling, Artwork and Promotional broacher or promotional material
10. Device Design Flow Chart
11. Device Design validation data
12. Production Process Flow Chart
13. Essential Requirements Checklist
14. Usability Engineering Test File
15. List of Applicable Standard
16. Biocompatibility Evaluation Report
17. Biocompatibility Testing Report
18. Animal Experiments of Feasibility
19. TSE/BSE Declaration Certificate
20. Sterilization validation Protocol and Report
21. Package Sealing Validation Report
22. Product Stability Report
23. Post-Market Surveillance
24. Finished product test report for three batches

1.0 EXECUTIVE SUMMARY:

An executive summary shall be provided by the manufacturer and shall contain:
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1.1 Introductory descriptive information on the medical device, the intended use and
indication for use, Class of Device, novel features of the device (if any), Shelf Life of
the Device and a synopsis on the content of the dossier .

1.1.1 (General Description, Material)______________________

1.1.2 Product Classification:

Class ____ according to __________________________

1.1.3 Intended Use:

__________________________

1.1.4 Contraindications:
__________________________

1.1.5 Shelf Life of the Device:

__________________________

1.1.6 Our (Product Name) have been sold in _________.

1.1.7 In this dossier, we are providing information on regulatory status of device, device
description, product specification, product verification and validation, Biocompatibility
studies, Sterilization, Clinical evidence and post marketing surveillance data Report.

1.2 Information regarding Sterilization of the Device (whether it is sterile or Non-sterile; if

sterile, mode of sterilization)
__________________________

1.3 Risk Management Plan, Risk Analysis, evaluation and control documents.
Please refer to ANNEXURE-1, Risk Management Report.

1.4 Clinical Evidence and evaluation (if applicable)

Please refer to ANNEXURE-2, Clinical Report.

1.5 Regulatory status of the similar device in India

Please refer to ANNEXURE-3, Regulatory status of the similar device in India. As no
further data is available on CDSCO Site, this list is till 2016. (For Lotus Surgicals)

1.6 Design Examination Certificate, Declaration of Conformity, Mark of Conformity

Certificate, and Design Certificate (if applicable). Copy of such certificate(s) shall
be enclosed.
Design Examination Certificate is Not Applicable as this is not a Class IIb device.
Please refer to ANNEXURE-4, EC Certificate.
Please refer to ANNEXURE-5, Declaration of Conformity.

1.7 Marketing History of the device from the date of introducing the device in the market
1.7.1 _____________
1.7.2 ____________________
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1.7.3 ____________________
1.7.4 ____________________
1.7.5 ____________________
1.7.6 ____________________

1.8 Domestic Price of the device in the currency followed in the Country of origin
____________________________

1.9 List of regulatory approvals or marketing clearance obtained (Submit respective copies
of Approval Certificates)
Approved Class of Date of First
Country Approved Indication
shelf life Device Approval
European Union

Turkey

Georgia

Ukraine

Please refer to ANNEXURE-6, Registration Approval Certificates. (P.S. If these

countries comes under European Union, please attach CE Certificate instead.)

 Status of pending or withdrawn request for market clearance, pending

withdrawn
There is no pending or withdrawn request & application for market clearance,
Approval and/or withdrawn.

1.10 Safety and performance related information on the device:

a. Summary of reportable events and field safety corrective action from the date of
introduction.
For Serious Adverse event: No adverse events reported till date.
For Field Safety Corrective Action (FSCA): There is no problem requiring FSCA.
Date of Reason for FSCA Countries where
FSCA FSCA was conducted

b. If the device contains any of the following material then descriptive information on
the following need to be provided:
 Animal or human cell tissues and/or derivatives thereof, rendered non-viable
(e.g. Porcine Heart Valve): Not Applicable. Our device don’t have this kind
material.

 Cells, tissues and/or derivatives of microbial recombinant origin (e.g. Dermal

fillers based in hyaluronic acid derived from bacterial fermentation process):
Not Applicable. Our device don’t have this kind material.

 Irradiating components, ionizing or non-ionizing: No, our product don’t have any
irradiating components, ionizing or non-ionizing.
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2.0 DEVICE DESCRIPTION AND PRODUCT SPECIFICATION, INCLUDING

VARIANTS & ACCESSORIES

2.1 The dossier should contain the following descriptive information for the device:
a. A general description of device including its Generic name, Model Name, Model No.,
Materials of Construction, Intended Use or Indications, Instructions for Use,
Contraindications, Warnings, Precautions and Potential Adverse Effects;

 DESCRIPTION:
______________________

 MODEL NUMBER:
______________________

 MATERIALS OF CONSTRUCTION:
Part name Material Specification

 INTENDED USE OR INDICATIONS:

____________________________

 INSTRUCTIONS FOR USE:

Please refer to the ANNEXURE-7 for “Instruction for use”.

 CONTRAINDICATIONS:
A. __________________
B. __________________
C. __________________
D. __________________
E. __________________

 PRECAUTIONS AND WARNINGS

A. __________________
B. __________________
C. __________________
D. __________________
E. __________________

 POTENTIAL ADVERSE EFFECTS:

No adverse events reports till date.

b. The intended patient population and medical condition to be diagnosed and/or

treated and other considerations such as patient selection criteria;
________________________________________

c. Principles of operation or Mode of Action, accompanies by animation/videos (if

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available);
Please refer to the ANNEXURE-7 for “Instruction for Use”.

d. An explanation of any novel features;

A. __________________
B. __________________
C. __________________
D. __________________
E. __________________

e. A description of the accessories, other medical device and other product that
are not medical device, which are intended to be used in combination with it. It
should also be clarifies whether these accessories/devices are supplied as a kit
or separate components.
________________________________________________________________

f. Description or complete list of the various configurations/variants of the device

that will be made available;
Name of Medical Devices
S. (Including model No’s, if applicable) Shelf
Indication and/or Intended Use
No. Life
Generic Name Model Name, if any
a)

b)

c)

d)

e)

g. A general description of the key functional elements, e.g. its parts/components

(including software if appropriate), its formulation, its composition, its
functionality. Where appropriate, this will include: labelled pictorial
representations (e.g. diagrams, photographs, and drawings), clearly indicating
key parts/components, including sufficient explanation to understand the
drawings and diagrams.
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
__________________________________________________
Please refer to ANNEXURE-9 Structure, Drawing, Material and Specification.
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h. A description of the materials incorporated into key functional elements and

those making either direct contact with a human body or indirect contact with
the body, e.g., during extracorporeal circulation of body fluids. Complete
chemical, biological and physical characterization of the material (s) of the
Medical Device.
S.
Material Physical Chemical Biological
No.
High resistivity, larger linear
1. expansion coefficient, Low Good corrosion resistance No any sensitization, carcinogenicity,
06Cr19Ni10
thermal conductivity, no and heat resistance, teratogenicity
magnetic
2.

3.

4.

i. For medical devices intended to emit ionising radiation, information on

radiation source (e.g. radioisotopes) and the material used for shielding of
unintended, stray or scattered radiation from patients, users and other persons
shall be provided.
No, the (Product Name)will not emit any ionising radiation.

2.2 Product Specification

(Product Pictures)
(Product Dimensions)

Features & Benefits

1. _____________________
2. _____________________
3. _____________________
4. _____________________
5. _____________________
6. _____________________

2.3 Reference to predicate and/or previous generations of the device

a. The Manufactures previous generation of the device, if such exists;
The (Product Name) is our first generation Device.

b. Predicate devices available on the local and International market;

__________________________________________________________________
__________________________________________________________________
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c. Comparative analysis to prove substantial equivalence to the predicate devices as claimed;

Device in question
CE-marked equivalent device (Ethicon, Inc)
Item (Your Company) Outcome
(Product Name) (Product Name)
Intended Use/Purpose

Clinical Condition

Used time

Population

Material

Photo (examples)

Manufacturing
Procedures

Biocompatibility

Packaging

Sterilization method Same sterilization method.

Conclusion

Date: Aug. 2019 10 Version No.: 02

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3.0 LABELLING
Please refer to ANNEXURE-7, for “Instruction for Use”.
Please refer to ANNEXURE-9, for “Labeling, Artwork and Promotional brochure or
promotional material”.

4.0 DESIGN AND MANUFACTURING INFORMATION

4.1 Device Design
Please refer to ANNEXURE-10, for “Device Design Flow Chart”.
Please refer to ANNEXURE-11, for “Device Design Validation Data”.

4.2 Manufacturing Processes

Please refer to ANNEXURE-12, for “Production Process Flow Chart”.

5.0 ESSENTIAL PRINCIPLES (EP) CHECKLIST

(i) The dossier should contain the following:-
(a) The essential principles;
(b) Whether each essential principle applies to the device and if not, why not;
(c) The method used to demonstrate conformity with each essential principle that
applies;
(d) A reference for the method employed (e.g., standard); and
(e) The precise identity of the controlled document that offers evidence of conformity
with each method used.
Please refer to ANNEXURE-13, for “Essential Requirements Checklist”.

(ii) Methods used to demonstrate conformity may include one or more of the following:
(a) Conformity with standards as referred to in rule 7;
(b) Conformity with an in-house test method;
(c) The evaluation of pre-clinical and clinical evidence;
(d) Comparison to a similar device already available on the market.
Please refer to ANNEXURE-13, for “Essential Requirements Checklist”.

(iii) The essential principles checklist should incorporate a cross-reference to the

location of such evidence both within the full technical documentation held by the
manufacturer and within the dossier.
Please refer to ANNEXURE-13, for “Essential Requirements Checklist”.

6.0 RISK ANALYSIS AND CONTROL SUMMARY

Please refer to ANNEXURE-1, for Risk Management Report, and related
SOP NO. __________________ (SOP for Risk Analysis or Ref. No. of Risk Management
Plan.)
The company establish risk management program according to ISO14971 standard,
aimed at to judge hazards associated with medical device and its accessories, estimate,
evaluate and control these risks, monitor the effectiveness of the control, to ensure that
our products are used according to the intended use, ensure the patient and the user's risk
to an acceptable level.

7.0 Verification and validation of the medical device

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7.1 A. a) Engineering Test and

Usability evaluation has been conducted acc. to EN 62366/ EN 62366-1. The Usability
Report demonstrated that no use errors would be caused by inadequate medical device
usability, ANNEXURE-14, “Usability Engineering File”. Potential risks in relation to
usability are discussed in the risk management. It can be concluded that such risks are
acceptable and no user training is needed for safe use of the device. The usability
engineering process provides safety for the patient, user and others related to usability.
The process addresses user interactions with the medical device according to the
accompanying document, including transport, storage, operation and disposal of the
device.

b) Lab Test;
(Product Name)are designed and tested acc. to the product specification. Performance,
safety and functional testing has been performed. The test was conducted by the
accredited laboratory (Lab Name) with representative samples of (Product Name, Code,
and Batch No.). The test items included appearance, packaging, size, hardness, tensile
strength, matching performance, flexibility, anastomosis and cutting performance,
sterility, etc.
.

c) Simulated Use Test;

Pre-clinical Evaluation
Pre-clinical evaluation was performed in framework of design validation. It includes
functional and performance testing acc. to the product specification.
Other tests and evaluation, e.g. Biocompatibility have also been performed. A separate
report for biocompatibility evaluation was prepared as ANNEXURE-16 Biocompatibility
Evaluation Report.
The Biocompatibility Testing Report are enclosed as ANNEXURE-17 Biocompatibility
Testing Report.

d) Any Animal tests for demonstrating feasibility or proof of concept of the finished
device product;
___________

e) Any published literature regarding the device or substantially similar devices

Please refer to ANNEXURE-2, for “Clinical Report”.

B. i) Declaration or certificate of conformity to a recognized standard and summary

of the Data if no acceptance criteria are specified in the standard;
Please refer to ANNEXURE-15, for “List of Applicable Standard”.

ii) Declaration or certificate of conformity to a published standard that has not been
recognized, supported by a rational or its use, and summary of the data if no
acceptance criteria is specified in the standard.
Not applicable, as the certificate of conformity as per the EU standards (CE Marking) is
provided in above point (A).
Please refer to ANNEXURE-15, for “List of Applicable Standard”.
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iii) Declaration or certificate of conformity to a professional guideline, industry

method, or in-house test method, supported by a rational for its use, a
description of the method used, and summary of the insufficient detail to allow
assessment of its adequacy.
Not applicable as the certificate of conformity as per the EU standards (CE marking)
is provided in above point (A).

C. a) Biocompatibility studies data as per prescribed standards;

Biocompatibility Evaluation is based on laboratory tests as defined for the product
category in table A.1 of EN ISO 10993-1.

Test report # ______________ Cytotoxicity acc. to ____________

Test report # ______________ Irritation acc. to _______________
Test report # ______________ Sensitization acc. to ____________
Test report # ______________ Pyrogen Test acc. to ____________

These tests were performed by the accredited laboratory ________________. Pls refer to
ANNEXURE 13 Biocompatibility Testing report.
Evaluation of biocompatibility is a continuous process. For this purpose, post-production
experience will be gathered and analyzed.
A separate report for biocompatibility evaluation was prepared as ANNEXURE-16
Biocompatibility Evaluation Report.
The Biocompatibility Testing Report are enclosed as ANNEXURE-17 Biocompatibility
Testing Report.

b) Medicinal substances incorporated into the device, including compatibility of

the device with the medicinal substances:
Not applicable as no medicinal substances are used in the device.

c) Biological safety of devices incorporating animal or human cells, tissues or

their derivatives;
Not applicable as no material of animal or human origin used.

d) Sterilization
Please refer clause section 7.8.

e) Software verification and validation;

Not applicable as no software used in device operation.

f) Animal studies that provide direct evidence of safety and performance of the
device, especially when no clinical investigation of the device was conducted;
Please refer to ANNEXURE-18, for “Animal Experiments of Feasibility”.

g) Clinical Evidences;
Please refer to ANNEXURE-2, for “Clinical Report”.
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D. Detailed information will describe the test design, complete test or study
protocol, methods of data analysis, in addition of that data summaries and
conclusions. Where no new testing has been undertaken, the dossier should
incorporate a rational for that decision, eg. Biocompatibility testing on the
identical materials was conducted when these were incorporated in a previous,
legally marketed version of the device. The rationale may be incorporated into
the Essential Principle checklist.
This is our first generation Device, so not applicable.

7.2 Biocompatibility;
i. List of all materials in direct or indirect contact with the patient or user.
Part name Material Specification

ii. Where biocompatibility testing has been undertaken (as per prescribed standards) to
characterize the physical, chemical, toxicological and biological response of a
material, detailed information should be included on the test conducted, standards
applied, test protocol, the analysis of data and the summary of the results. At a
minimum, test should be conducted on samples from the finished sterilized (when
supplied sterile) device.
Please refer the ANNEXURE-16, for “Biocompatibility Evaluation Report “and
ANNEXURE-17 for “Biocompatibility Testing Report”.

7.3 Medicinal Substances;

Not applicable, the product don’t have any medicinal substances.

7.4 Biological Safety;

Not Applicable; as no material of human or animal origin is used in the device.
Please refer the ANNEXURE-19, for TSE/BSE Declaration Certificate.
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7.5 Sterilization;
i. Where the device is supplied sterile, the dossier should contain the detailed
information of the initial sterilization, validation including sterilizer
qualification, bioburden, testing, pyrogen, testing for sterilant residue (if
applicable) and packaging validation as per prescribed standards. Typically, the
detailed validation information should include the method used, sterility
assurance level attained, standard applied the sterilization protocol developed in
accordance with prescribed standards, and a summary of results.

 The devices are sterilized with ______________________. The sterilization is

performed by the follow sterilization facility: _______________.
 The SAL value is defined for equal as or low than _________.
 The sterilization process is followed to EN ISO 11137-1 and -2. Sterilization
dose is established acc. to EN ISO 11137-2.
Please refer the ANNEXURE-20, for Sterilization validation Protocol and
Report.

ii. Evidence of the ongoing revalidation of the process should also be provided.
Typically this should consist of arrangement for, or evidence of, revalidation of
the packaging and sterilization processes.
Package and/or sterile barrier system;
The sterile barrier system consists of 3 packaging steps: primary sterile packaging for
each unit, middle packaging, and the sales packaging for shipping.
The material for primary packaging is sterile blister made of 1073B on one side and
PETG on the other side. Middle packaging is a white paper box and the sales
packaging is corrugated carton.

The sealing process is specified in work instruction. The critical parameters for
sealing process are pressure and temperature.
Packaging/Sealing validation was performed according to EN ISO 11607-1, EN ISO
11607-2 and EN 868-5.
The test items include:
- Sterile barrier system completely formed/assembled;
- Product fits into the sterile barrier system;
- Essential dimensions are met;
- Intact seal for a specified seal width;
- Seal seam: no channels or open seals; no punctures or tears; no material
delamination or separation;
- Strength of the heat seal joint not be less than 1.5 N per 15 mm width;
- Proving microbial barrier properties via bacteria penetration test.
The test was performed for new produced packaging and packaging after aging
process.
Test reports refer to ANNEXURE-21, for “Package Sealing Validation Report”.
The following is a list of changes which could affect the status of a validated process:
- raw material changes that would impact the process parameters;
- a new piece of equipment is installed;
- transfer of processes and/or equipment from one facility or location to another;
- sterilization-process changes;
- Negative trends in quality or process control indicators.
For the above mentioned changes, the need for revalidation will be evaluated and
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documented. If the situation does not require that all aspects of the original validation
be repeated, this revalidation does not have to be as extensive as the initial validation.
Periodic revalidation or reviews will be considered since multiple minor changes
could cumulatively affect the validation status of the process.

7.6 Software Verification and Validation;

Not Applicable; as not software is used in the device operation.

7.7 Animal Studies;

i. Where studies in an animal model have been undertaken to provide evidence of
conformity with the Essential Principle related to functional, safety and
performance detailed information should be contained in the dossier.
Please refer the ANNEXURE-18, for “Animal Experiment of Feasibility”.

ii. The dossier should describe the study objectives, methodology, results, analysis
and conclusion and document conformity with Good Laboratory Practices. The
rationale (and limitations) of selecting the particular animal model should be
discussed.
Please refer the ANNEXURE-18, for “Animal Experiment of Feasibility”.

7.8 StabilityData;
Shelf Life of the device is defined for 3 years after sterilization.
Please refer the ANNEXURE-22 for “Product Stability Report”.

7.9 Clinical Evidence;

The dossier should contain the clinical evidence that demonstrate the conformity of the
device with the Essential Principle that applied to it. It needs to address the elements
contained in the Clinical Investigation, as specified under the seventh schedule. If a
predicate device is available, the manufacturer needs to submit the substantial
equivalence evaluation along with relevant published literature in accordance with these
rules.
Please refer the ANNEXURE-2, for “Clinical Report”.

7.10 Post Marketing Surveillance Data (Vigilance Reporting)

Please refer to ANNEXURE-23, for “Post-Market Surveillance”.

 Finished Product Test Report/Certificate of Analysis for three batches

Please refer to ANNEXURE-24, for “Finished Product Test Report for three batches”.