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Syllabus For Medical Devices

This document outlines 15 modules that provide an overview of medical device and allied fields regulation from international, US, EU, and Indian perspectives. The modules cover topics such as the classification of medical devices; current good manufacturing practices; medical device regulatory affairs including pre-market and post-market requirements; risk management; biocompatibility; clinical trials; in vitro diagnostic devices; combination products; and emerging areas in the industry. The goal is to introduce students to key concepts, standards, and regulations pertaining to medical devices on a global scale.

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Apoorva Ganguly
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0% found this document useful (0 votes)
1K views4 pages

Syllabus For Medical Devices

This document outlines 15 modules that provide an overview of medical device and allied fields regulation from international, US, EU, and Indian perspectives. The modules cover topics such as the classification of medical devices; current good manufacturing practices; medical device regulatory affairs including pre-market and post-market requirements; risk management; biocompatibility; clinical trials; in vitro diagnostic devices; combination products; and emerging areas in the industry. The goal is to introduce students to key concepts, standards, and regulations pertaining to medical devices on a global scale.

Uploaded by

Apoorva Ganguly
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Module 1: Introduction to Medical Devices and allied fields

Includes broadly historical Perspective, definition, regulation, classification,


nomenclature, examples, applicable standards, challenges, global concerns, update
(which ever topics applicable)
1. Introduction to Medical Devices
2. Introduction to in vitro devices
3. Introduction to Biologics
4. Introduction to Combination Products
Module 2: Current Good Manufacturing Practices I (International
Perspective)
1. US FDA: Quality System Regulation; 21 Code of Federal Regulation, part
820 (21 CFR Part 820)
a) Includes detailed information about Design controls, document
controls, identification and traceability, production and process
controls, process validation, Corrective and Preventive Action
2. FDA inspection approach
a) Preparing, managing, inspection conclusion, common pitfalls
observed
Module 3: Current Good Manufacturing Practices II (International
Perspective)
1. European Union: Quality Management System for a Medical Device
(QMS,ISO 13485)
a) Compare the requirements between ISO 13485 and ISO 9001
b) Interpret the clauses of ISO 13485
c) Recognize the role and responsibilities of management
d) Recognize the relationship between QMS and risk analysis (ISO 14971)
e) Compare the requirements between EU QMS (ISO 13485) and US FDA
Quality System Regulation (21 CFR Part 820)
Module 4: Current Good Manufacturing Practices III (Indian
Perspective)
1. Drugs and cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
a) Schedule M, Part III (Requirements for the manufacture, import and
sale of medical devices)
b) Role of Clean Room in GMP
Module 5: Medical Device Regulatory Affairs I (International perspective,
USA) Part 1
1. Overview of Medical Device Regulation
a) Classify your Medical Device
b) Regulatory Controls
c) Medical Device User Fee and Modernization Act
d) Device Labeling
2. CDRH Introduction, mission, organigram
3. How to study and market your device
a) Pre market Requirements
b) Medical Device Registration and listing
4. Pre market submissions

a) Pre market notification 510(k)


b) Pre market Approval
Module 6: Medical Device Regulatory Affairs I (International perspective,
USA) Part 2
1. Post Market Requirements
a. Mandatory reporting requirements
b. Recalls , correction and removals
i. Overview and definitions
ii. Voluntary recalls 21 CFR Part 7
iii. Mandatory Device Recalls - 21 CFR 810
iv. Corrections and Removals - 21 CFR 806
v. Regulations
vi. Federal Register Notices
c. Medical Device Tracking
2. Importing and exporting Devices
3. Unique device Identification
Module 7: Medical Device Regulatory Affairs II (International perspective,
EU) Part 1
1. Medical Device Directives
a) Medical Device Directive - 93/42/EEC
b) Active Implantable Medical Device Directive - 90/385/EEC
c) Essential requirements checklist
d) Clinical evaluation reports
e) Risk analysis
f) CE Certification
Module 8: Medical Device Regulatory Affairs II (International perspective,
EU) Part 2
1. Conformity Assessment Bodies (CAB) and CE Marking [Detailed about Class I,
I(s), I(m), IIa, IIb and III Devices]
2. About Notified Bodies and EU authorized representative
3. Post Marketing Requirements
Module 9: Medical Device Regulatory Affairs III (Indian perspective)
1. Indian Market overview
2. Medical Device Regulatory structure
3. Overview of regulatory status Notified Devices
4. Registration Procedure for medical devices (Includes Documentation
information, Form 40)
5. Registration validity and timeframes
a) Medical Device import (Form 10) and Registration
b) Medical Device exports and Free Sales Certificates
6. Dossier contents
a) Device Master File
b) Site Master File
c) Product Labeling
d) Shelf life
e) Essential Principles Checklist

7. Challenges to regulations
Module 10: Introduction to Risk Management to Medical Devices
1. Documentation requirements
2. Failure Mode Effect Analysis (FMEA)
3. Fault Tree Analysis (FTA)
4. Hazard Analysis and Critical Control Points (HACCP)
Module 11: Biocompatibility Studies
General Idea about Biological evaluation of medical devices ISO 10993
Part 1 to Part 20
Detailed analysis of common specific tests:
1. Cytotoxicity
2. Sensitization
3. Irritation/ intra - cutaneous Toxicity
4. Acute Systemic Toxicity
5. Sub Chronic Toxicity
6. Genotoxicity
7. Implantation
8. Hemocompatibility
9. Chronic toxicity
10. Carcinogenecity
Module 12: Clinical Trials: Medical Devices
1. US FDA: Investigational Device Exemption & GCP
a) Investigational Device Exemption - 21 CFR Part 812
b) Protection of human subjects - 21 CFR Part 50
c) Institutional Review Board - 21 CFR Part 56
d) Financial disclosure by clinical investigators - 21 CFR Part 54
e) Design controls - 21 CFR Part 820 Subpart C
2. Clinical investigation of Medical Devices for human subjects Good Clinical
Practice - ISO 14155
3. Difference
between ISO 14155 and International Conference on
Harmonization Good Clinical Practice
4. Indian Perspective Drugs & Cosmetics Act, Schedule Y
Module 13: Overview of In Vitro Device Regulation
1. US Perspective
a) Classification
b) Information about general purpose reagent and analyte specific
reagents
c) Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)
d) Pre submission process
Pre market notification 510(k)
Pre market Approval
e) Labeling Requirements
f) In vitro Device Listing
g) In vitro Device Reporting
2. EU Perspective

In vitro Diagnostic Directive 98/79/EC


Introduction to In vitro Diagnostics Devices
Introduction to CE Marking for in vitro Diagnostics Directive
Applications of the In vitro Diagnostic Directive
Technical Files and Design Dossiers for In vitro Diagnostics
Performance evaluation and Clinical Evidence for in vitro diagnostics
3. Indian Perspective; IVDs and diagnostics
a)
b)
c)
d)
e)
f)

Module 14: Overview of Combination Products Regulation


Includes Indian and International perspective of:
1.
Regulatory Guidelines
2.
Current Good Manufacturing Practices
Module 15: Medical Devices and allied fields: Emerging Area
1. Medical Device Industry Trends and Challenges
2. Relevant Medical Device Industry experience sharing: anecdotes from
Industry Professionals
3. Career opportunities
Glossary:
1. Important Terms
2. Medical Device Databases

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