Medical Regulatory Affairs
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Medical Regulatory Affairs Syllabus — Unit-wise Content
The official GTU curriculum for Medical Regulatory Affairs (subject code 4360303) as prescribed for Biomed · Semester 6 divides the course into 5 units, covering 37 listed topics. This curriculum applies from the Jan-2024 intake. The unit-wise breakdown below is read from the GTU syllabus document for this subject code, so you can check what the course actually covers before deciding which papers to attempt.
Download the official syllabus PDF (4360303)Unit 1 Introduction to medical Regulatory Affairs
- 1.1. Role of Regulatory Affairs in the Biomedical Industry
- 1.2. Regulatory Agencies and their Functions : FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), The Central Drugs Standard Control Organization(CDSCO), IPC, NPPA and Other global regulatory authorities
- 1.3. Classification of Medical device a per FDA
- 1.4. Classification of Medical device a per CDSCO
- 1.5. Regulatory requirements for different device classes
Unit 2 Medical device safety and risk management
- 2.1. Medical device safety and risk management
- 2.2. Phases in life span of medical device 2.3Critical elements for regulatory attention
- 2.3.1. product and use
- 2.3.2. product representation
- 2.4. Stages of regulatory control
- 2.5. Common framework of medical device
- 2.6. Regulatory tools and general requirements
- 2.6.1. Product control
- 2.7. GHTF(Global Harmonization Task Force) Medical Regulatory Affairs Course Code: 4360303 NITTTR Bhopal – GTU - COGC-2022 Curriculum
Unit 3 Standards
- 3.1.1. Need of standards
- 3.1.2. Voluntary and mandatory standards
- 3.1.3. Standard Development process
- 3.1.4. National and International Standard system
- 3.1.5. Identifications of standards
- 3.1.6. Current trends in use of standards in medical device regulations
- 3.1.7. BIS- Bureau of Indian Standards
- 3.2. Environmental Considerations in medical device regulations
Unit 4 Regulation and standards in medical devices for EU European Union
- 4.1. Harmonized standards and various bodies in EU
- 4.2. risk based classification of medical device in EU
- 4.3. CE mark and requirement of medical device for CE mark 4.4 procedure to obtain CE mark
- 4.5. labelling process
- 4.6. technical documentation and risk management system
- 4.7. pre market and post market scenario of CE marked medical device
Unit 5 Regulation and standards in medical devices for India United states medical
- 5.1. laws governing medical device and governing bodies
- 5.2. risk based classification of medical device
- 5.3. role of distributors and subsidiary bodies
- 5.4. product registration process and quality system regulations
- 5.5. labelling and technical requirements
- 5.6. clinical trails
- 5.7. commercial aspects and regulations on price
- 5.8. Upcoming medical regulations in India Medical Regulatory Affairs Course Code: 4360303 NITTTR Bhopal – GTU - COGC-2022 Curriculum
- 5.8.1. Regulatory updates and innovative platforms launched by Government if any- (ex.Medtech Mitra ) Note: The UOs need to be formulated at the ‘Application Level’ and above of Revised Bloom’s Taxonomy’ to accelerate the attainment of the COs and the competency.
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