Draft Proposal to amend certain provisions under Medical Devices Rules 2017 EU

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-10042026-271703 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 249] NEW DELHI, FRIDAY, APRIL 10, 2026/CHAITRA 20, 1948 2597 GI/2026 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th April, 2026 G.S.R. 269(E). - The following draft of certain rules further to amend Medical Devices Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub- section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published 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 drugsdiv- [email protected]. DRAFT RULES 1. (i) These rules may be called the Medical Devices (......... Amendment) Rules, 2026. (ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette. 2. In the Medical Devices Rules, 2017 (hereinafter referred to as said rules), in rule 19H, in sub-rule (2), in clause (v), after the word "standards", the word "and Quality Management System" shall be inserted. 3. 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. 4. In the said rules, in rule 19, for the marginal heading, the following marginal heading shall be substituted, namely: – "Government Medical Device Testing laboratories" 5. 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. [F. No. X.11035/112/2024-DR] HARSH MANGLA, Jt. Secy. Note: The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 78 (E), dated the 31st January, 2017 and last amended vide notification number G.S.R. (E), dated Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. SARVESH KUMAR SAH SRIVASTAVA KUMAR SRIVASTAVA Date: 2026.04.10 22:07:59 +0530