Amendment 2020

This page tracks amendments, circulars, and gazette notifications to the Medical Devices Rules 2017 issued in 2020. Key 2020 amendments included modifications to import authorization procedures and clarifications on device classification requirements.

Official source: Official Gazette of India; CDSCO

2020 amendments introduced stricter import authorization requirements, including enhanced documentation standards for Form MD-14 and MD-15 submissions, clarified the scope of 'deemed approval' provisions, and refined classification criteria alignment with IMDRF guidance documents.