JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to impart the fundamental knowledge on the medical

devices and in vitro diagnostics, basis of classification and product life cycle of medical devices, regulatory requirements for approval of medical devices in regulated countries like US, EU and Asian countries along with WHO regulations. It prepares the students to learn in detail on the harmonization initiatives, quality and ethical considerations, regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.

Course Outcome

Upon completion of the course, the student shall be able to know;

• Basics of medical devices and IVDs, process of development, ethical and quality considerations.
• Harmonization initiatives for approval and marketing of medical devices and IVDs.
• Regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN.
• Clinical evaluation and investigation of medical devices and IVDs.

UNIT - I

Medical Devices: Introduction, Definition, Risk based classification and Essential Principles of Medical Devices and IVDs. Differentiating medical devices IVDs and Combination Products from that of pharmaceuticals, History of Medical Device Regulation, Product Lifecycle of Medical Devices and Classification of Medical Devices. IMDRF/GHTF: Introduction, Organizational Structure, Purpose and Functions, Regulatory Guidelines, Working Groups, Summary Technical Document (STED), Global Medical Device Nomenclature (GMDN).

UNIT - II

Ethics: Clinical Investigation of Medical Devices, Clinical Investigation Plan for Medical Devices, Good Clinical Practice for Clinical Investigation of medical devices (ISO 14155:2011) Quality: Quality System Regulations of Medical Devices: ISO 13485, Quality Risk Management of Medical Devices: ISO 14971, Validation and Verification of Medical device, Adverse Event Reporting of Medical device

UNIT - III

USA: Introduction, Classification, Regulatory approval process for Medical Devices (510k) Premarket Notification, Pre-Market Approval (PMA), Investigational Device Exemption (IDE) and In vitro Diagnostics, Quality System Requirements 21 CFR Part 820, Labeling requirements 21 CFR Part 801, Post marketing surveillance of MD and Unique Device Identification (UDI). Basics of In vitro diagnostics, classification and approval process.

UNIT - IV

European Union: Introduction, Classification, Regulatory approval process for Medical Devices (Medical Device Directive, Active Implantable Medical Device Directive) and In vitro Diagnostics (In Vitro Diagnostics Directive), CE certification process. Basics of In vitro diagnostics, classification and approval process.

UNIT - V

ASIAN, China & Japan: Medical Devices and IVDs, Regulatory registration procedures, Quality System requirements and clinical evaluation and investigation. IMDRF study groups and guidance documents.

REFERENCE BOOKS:

• 1. FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics by Douglas J. Pisano, David Mantus.
• 2. Medical Device Development: A Regulatory Overview by Jonathan S. Kahan
• 3. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices byJohn J. Tobin and Gary Walsh
• 4. Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics by Carmen Medina M.Pharm I Year II Sem (Pharmaceutical Regulatory Affairs)