The Ministry of Health and Family Welfare (MoHFW) on April 10, 2026, issued the Draft Medical Devices (.........Amendment) Rules, 2026 to further amend the Medical Devices Rules, 2017.
The following amendments have been stated:
• In the Medical Devices Rules, 2017, in rule 19H, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted.
• In the said rules, in rule 19J, in sub-rule (2), in clause (v), after the word “standards”, the word “and Quality Management System” shall be inserted.
• In the said rules, in rule 19, for the marginal heading, the following marginal heading shall be substituted, namely: –
“Government Medical Device Testing laboratories”
• In the said rules, in rule 63, in sub-rule (1), in Proviso (iv), after the words “or Japan”, the words, “or European Union countries,” shall be inserted.
The drat is issued after consultation with the Drugs technical Advisory Board for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to public;
Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, C Wing, Kartavya Bhavan, New Delhi - 110001 or emailed at [email protected].
[Notification No. G.S.R. 269(E)]
