Amendment 2021 2023

This page tracks amendments, circulars, and gazette notifications to the Medical Devices Rules 2017 issued between 2021 and 2023. These amendments strengthened post-market surveillance, enhanced adverse event reporting requirements, and refined import compliance procedures.

Official source: Official Gazette of India; CDSCO

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Key amendments during 2021–2023 introduced stricter adverse event reporting requirements, enhanced import compliance procedures, and aligned Indian medical device classification with IMDRF frameworks. These amendments strengthen post-market surveillance and import authorization processes.