Medical Devices Rules � 11th Edition, 2026 is a comprehensive legal and regulatory reference covering the framework governing medical devices and in-vitro diagnostic medical devices in India. The book brings together important rules, lists, guidelines, forms, checklists, notifications and regulatory information relevant to the manufacture, regulation, testing, auditing and safety of medical devices.
The edition includes material relating to Risk Class, Auditing Bodies, Testing Laboratories, Medical Device Adverse Event Reporting, Verification, Safety and Performance, MDTA, MDTL, MvPI, NPPA, RTI, Drugs & Cosmetics (Compounding of Offences) Rules, 2025, along with related Gazette and Government documents.
It is designed as a practical reference for legal professionals, medical-device manufacturers, regulatory affairs professionals, healthcare organizations, testing laboratories, auditors, researchers, students and government/regulatory authorities.

Key Features

� List of Medical Devices and In-Vitro Diagnostics
� Classification of Medical Devices according to Risk Class
� Information relating to Auditing Bodies & Testing Laboratories
� Guidelines and FAQs on Medical Devices Rules
� FAQ on Fees and Documents
� Gazette and Government documents relating to medical devices
� Medical Device Adverse Event Reporting Form
� Checklist for Verification
� Essential principles for Safety and Performance of Medical Devices
� Regulatory information concerning MDTA, MDTL and MvPI
� Information relating to NPPA and RTI
� Drugs & Cosmetics (Compounding of Offences) Rules, 2025

Core Subjects

� Medical Devices Regulation
� Medical Devices Rules
� In-Vitro Diagnostic Medical Devices
� Medical Device Classification
� Risk Classification
� Medical Device Licensing & Compliance
� Medical Device Safety & Performance
� Medical Device Testing
� Testing Laboratories
� Auditing Bodies
� Medical Device Adverse Event Reporting
� Medical Device Verification
� Regulatory Affairs
� MvPI
� NPPA
� MDTA
� MDTL
� Drugs & Cosmetics Law
� Healthcare Regulation
� Medical Device Regulatory Compliance
� Government Notifications & Gazette Documents

Ideal For

� Medical Device Manufacturers
� Regulatory Affairs Professionals
� Healthcare Organizations
� Medical Device Importers & Distributors
� Testing Laboratories
� Auditing Bodies
� Advocates
� Law Students
� Researchers
� Compliance Professionals
� Government & Regulatory Authorities