Ilbco's Medical Devices Rules", 10th Edition, 2025, revised and published by Rajan Nijhawan. This publication provides a comprehensive guide to the legal framework and regulations governing medical devices in India.
The book covers the latest amendments and notifications issued by the Ministry of Health & Family Welfare and the Central Drugs Standard Control Organisation (CDSCO) up to 2025.
It includes details on device classification, licensing procedures, import/export requirements, quality management systems, and post-market surveillance.
Key topics listed on the cover include the List of Medical Devices and In-Vitro Diagnostics with Risk Class, Auditing Bodies & Testing Labs, and FAQs on Fees and Documents.