ILBCO's Medical Devices Rules | List of Medical Devices and In-Vitro Diagnostics with Risk Class

ILBCO's Medical Devices Rules is a comprehensive reference manual revised and published by Rajan Nijhawan. This 11th Edition (2026) serves as an extensive guide to the regulatory framework governing medical devices and in-vitro diagnostics in India. The book includes the list of medical devices and in-vitro diagnostics with risk class, auditing bodies and testing laboratories, guidelines, FAQs on fees and documents, FAQs on Medical Devices Rules, Gazette notifications and documents relating to medical devices, Medical Device Adverse Event Reporting Form, Checklist for Verification, Essential Principles for Safety and Performance of Medical Devices, MDTAG, MDTL, MvPI, NPPA, RTI, and the Drugs & Cosmetics (Compounding of Offences) Rules, 2025. It is an indispensable reference for regulatory professionals, medical device manufacturers, healthcare institutions, compliance officers, auditors, consultants, legal professionals, and students working in medical device regulation and healthcare compliance.