Third Amendment in Medical Device Rules, 2017

REGD. No. D. L.-33004/99 The Gazette of India EXTRAORDINARY CG-DL-E-21082026-275639 PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 678] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 14th August, 2026 G.S.R. 744(E).— Whereas a draft of certain rules further to amend Medical Device Rules, 2017, were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R. 269(E), dated the 10th April, 2026 as required by Sub-section (1) of section 12 and Sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), inviting objections and suggestions from all person likely to be affected thereby before the expiry of a period of thirty days from the date which on the copies of the Official Gazette containing the said notification was published were made available to public; And whereas, copies of the said Official Gazette were made available to the public on 10th April, 2026; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:— 1. (i) These rules may be called the Medical Devices (Third 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. 165(E), dated 2nd March, 2026. 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.