India’s Ministry of Health and Family Welfare has published draft amendments to the Medical Devices Rules, 2017, via G.S.R. 515(E) in the Extraordinary Gazette of India, aiming to significantly accelerate device licensing timelines.
The proposed Medical Devices (Amendment) Rules, 2026, drafted under the Drugs and Cosmetics Act, 1940, introduce sharper deadlines at every stage of the approval process. State Licensing Authorities will be required to complete application scrutiny for Class B devices and assign them to Notified Bodies within 30 days. Site audits by registered Notified Bodies must conclude within the same window, with final audit reports due within 15 days thereafter.
Additionally, compliance verification timelines following quality non-conformances have been shortened — from 45 to 30 days under Rule 21, from 60 to 55 days under Rule 23, and from 45 to just 20 days under Rule 25.
Stakeholders may submit objections or suggestions within 30 days to drugsdiv-mohfw@gov.in or to the Under Secretary (Drugs), Kartavya Bhavan, New Delhi – 110001.
Written By: Sayan Das
Graphics by: Pramit Hazra
