Medical Regulatory Affairs
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Follow on Instagram for UpdatesMedical Regulatory Affairs Syllabus — Unit-wise Content
The official GTU curriculum for Medical Regulatory Affairs (subject code DI05003071) as prescribed for ELECTRICAL · Semester 5 divides the course into 5 units, covering 9 listed topics. 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 (DI05003071)Unit 1 Introduction to Medical Regulatory Affairs 06
- 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 09
- 2.1 Medical device safety and risk management 2.2 Phases in life span of medical device 2.3 Critical elements for regulatory attention 2.3.1 Intended Use and Product Claims 2.3.2 Product Labelling and Documentation 2.4 Stages of regulatory control 2.5 Common Framework of Medical Device Regulations 2.6 Risk Analysis and Risk Control Measures 2.7 Regulatory tools and Product control 2.8 IMDRF (International Medical Device Regulators Forum) and 20% Program Name: Diploma Engineering Level: Diploma Branch: Biomedical Engineering Subject Code: DI05003071 Subject Name: Medical Regulatory Affairs Global Harmonization 2.9 Environmental and Safety Considerations in Medical Devices
Unit 3 Standards and Quality Systems for Medical Devices 10
- 3.1 Standards 3.1.1 Need and importance 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 Types and Identification of Standards: ISO, IEC, ANSI and BIS 3.1.6 Current Trends in Use of Standards in Medical Device Regulations 3.1.7 BIS (Bureau of Indian Standards) 3.2 Quality Management System for Medical Devices 3.2.1 Introduction to ISO 13485 3.2.2 Quality Documentation and Compliance 3.3 Environmental Considerations in Medical Device Regulations
Unit 4 European Union Medical Device Regulatory Framework 10
- 4.1 Harmonized Standards and Regulatory Bodies in EU 4.2 Risk-based Classification of Medical Devices in EU 4.3 CE Mark and Requirements for CE Certification 4.4 Procedure to Obtain CE Mark 4.5 Labelling and Technical Documentation 4.6 Risk Management System for CE Marked Devices 4.7 Pre-market and Post-market Surveillance of Medical Devices
Unit 5 Indian and US Medical Device Regulatory Framework 10
- 5.1 Laws Governing Medical Devices and Regulatory Bodies in India and USA 5.2 Risk-based Classification of Medical Devices 5.3 Product Registration Process and Quality System Regulations 5.4 Labelling and Technical Requirements 5.5 Clinical Evaluation and Regulatory Approval Process 5.6 Commercial Aspects and Price Regulations of Medical Devices 5.7 Recent Trends in Medical Device Regulations 25% Program Name: Diploma Engineering Level: Diploma Branch: Biomedical Engineering Subject Code: DI05003071 Subject Name: Medical Regulatory Affairs Medical Devices Rules (MDR)
- 2017 and recent amendments National Medical Device Policy 2023 MedTech Mitra Sugam Portal AI and Digital Health Overview
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