Regulatory Standards for Medical Devices
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Follow on Instagram for UpdatesRegulatory Standards for Medical Devices Syllabus — Unit-wise Content
The official GTU curriculum for Regulatory Standards for Medical Devices (subject code 2180307) as prescribed for Biomed · Semester 8 divides the course into 5 units, covering 44 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 (2180307)Unit 1 Introduction of Medical Devices
- Definition and Lifecycle Definition of medical devices: global perspectives
- Types of Medical Devices
- Market Trends for Medical Devices
- Safety issues
- Development of regulation and standards
- Life cycles of Medical devices from research and development until regulatory approval
Unit 2 Medical Device Regulation in the US
- General Regulation of Medical Devices
- Overview of US Medical Device Regulation
- Device Development
- Quality Systems and Agency Interactions
- Marketing Submissions
- Labeling and Promotion
- Post-market Considerations and Requirements
Unit 3 Quality and Compliance & Medical Device Regulation in the EU
- Overview of Medical Devices Directives
- Classification of Medical Device in EU, Conformity Assessment Procedures
- Essential Requirements
- Quality Management System (ISO 13485)
- Risk Management (ISO 14971)
- Clinical Evaluation
- CE Mark Certificate and Declaration of Conformity
- Post- Market Surveillance
- Combination Products Regulated as Medicinal Products
Unit 4 Medical Device Regulatory System in China
- Definition of medical device
- classification of medical devices
- Registration 08 15 SUBJECT CODE:2180307 Process
- Medical devices registration certificate
- Product testing
- Clinical trials
- Enforcing GMPs
- China Compulsory Certification Mark (CCC)
Unit 5 Medical Device Regulatory System in India
- Overview of Regulatory Environment
- Functions Undertaken by DCGI and FDA, Indian Pharmacopoeial Commission
- Detail of Key Regulator(s)
- Role of Distributors or Local Subsidiaries
- Product Registration or Conformity Assessment Route and Time Required
- Quality System Regulation
- Product Registration and Quality System Regulation for Combined Device–Drug Product
- Registration Fee, Technical Material Requirement
- Post- Marketing
- Manufacturing-Related Regulation
- Clinical Trial-Related Regulation
- Commercial Aspect
- Upcoming Regulation Changes
- Related Agencies/Departments and Ministries Total - 54 100
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