The Ministry of Health and Family Welfare has issued a draft amendment to the Medical Devices Rules, 2017. The proposal updates provisions related to government medical device testing laboratories, quality management system language in rules 19H and 19J, and recognition of European Union countries under rule 63. The draft is open for objections and suggestions within 30 days.
This draft notification, issued as G.S.R. 269(E) on 10 April 2026, proposes amendments to the Medical Devices Rules, 2017 after consultation with the Drugs Technical Advisory Board.
The key changes include inserting “and Quality Management System” after the word “standards” in rules 19H and 19J, substituting the marginal heading of rule 19 with “Government Medical Device Testing laboratories,” which was previously called as 'Central Medical Devic Testing Laboratory" and amending rule 63 to include “European Union countries” in the relevant proviso after “Japan.”
The draft has been published for public information and comments, which may be submitted within 30 days of the Gazette being made available. The notification states that objections and suggestions will be considered by the Central Government before finalization