Amendments under Medical Devices Rules 2017

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-27062026-273896 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 464] NEW DELHI, WEDNESDAY, JUNE 24, 2026/ASHADHA 3, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 23rd June, 2026 G.S.R. 515(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, First Floor, Kartavya Bhavan 1, New Delhi - 110001 or emailed at [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 20, in sub-rule (5), the following shall be substituted, namely: - The State Licensing Authority shall complete the scrutiny of the application in respect of Class B device and to be assigned to notified bodies within a period of thirty days from the date of online submission of application. Provided that where deficiencies that can be rectified, are pointed out by the State Licensing Authority within the stipulated period, the period referred to in sub-rule (5) shall reckon from the date these deficiencies have been removed. 5 (A) The Manufacturing site of the applicant shall conform to the requirements of Quality Management System as specified under the Fifth Schedule and applicable standards as specified under these rules and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before grant of licence. 3. In the said rules, in rule 20, in sub-rule (6), in Clause (i) and Clause (ii) the following shall be substituted, namely: - (i) "The State Licensing Authority shall ensure that the audit of the site is carried out by the registered Notified Body in the manner specified in the Third Schedule within a period of thirty days from the date of assignment of applications to notified body and the report of the audit carried out by the notified body shall be submitted to the State Licensing Authority. (i)(a) In case of non-conformance of Quality Management System requirements as observed during the Audit by the registered notified body, the compliance verification shall be carried out within twenty days from the date of receipt of compliance report from manufacturer." (ii) the Notified Body shall furnish its final report along with the recommendations to the State Licensing Authority within fifteen days of the completion of audit;" 4. In the said rules, in rule 21, in sub-rule (4), the word "forty five" shall be replaced with the word "thirty" 5. In the said rules, in rule 23, in sub-rule (1), the word "sixty" shall be replaced with the word "fifty five” 6. In the said rules, in rule 23, after sub-rule (2), the following sub-rule (3) shall be inserted, namely: - (3) In case of non-conformance of Quality Management System requirements as observed during the inspection by the inspection team referred to in sub-rule (1), the compliance verification shall be carried out within fifteen days from the date of receipt of compliance report from manufacturer. 7. In the said rules, in rule 25, in sub-rule (1), the word "forty-five" shall be replaced with the word “twenty” [F. No. X.11035/112/2024-DRS-Part(1)] 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.