Inclusion of Qualifications of Inspector (Medical Devices) under Rule 18 of the Medical Devices Rules, 2017

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-10032026-270811 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 159] NEW DELHI, TUESDAY, MARCH 10, 2026/PHALGUNA 19, 1947 1705 GI/2026 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2nd March, 2026 G.S.R. 165(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. 748(E), dated the 10th October, 2025 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 the 10th October, 2025; 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. (1) These rules may be called the Medical Devices (Amendment) Rules, 2026. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Medical Devices Rules 2017, after Rule 18, the following rule shall be inserted, namely: — "18A. Qualifications of Inspector A person who is appointed as an Inspector under the Act for the purposes of the implementation of the Medical Devices Rules, 2017 shall be a person who has a (i). Bachelor's degree in engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics Engineering from a recognised university or institute; or (ii). Bachelor's degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or Chemistry or Life Sciences from a recognised university or institute. 18B. Qualifications of Government Analyst. A person who is appointed as a Government analyst under the Act shall be a person who has a (a) Bachelor's of engineering or equivalent in Bio medical or Chemical or Mechanical or Electrical or Electronics or Instrumentation or Bio-technology or Polymer or Computer Science or Medical Electronics Engineering from a recognised university or institute; and who possesses not less than five years' post- graduate experience in the testing of medical devices or in-vitro diagnostics devices in a laboratory under the control of - (i) a Government Analyst appointed under the said Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority (or has completed two years' training on testing of medical devices or in-vitro diagnostics devices); Or, (b) Bachelor's degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio- Chemistry or Chemistry or Life Sciences from a recognised university or institute and possesses not less than five years' post-graduate experience in the testing of medical devices or in-vitro diagnostics devices in a laboratory under the control of - (i) a Government Analyst appointed under the said Act, or (ii) the head of an institution or testing laboratory approved for the purpose by the appointing authority (or has completed two years' training on testing of medical devices or in-vitro diagnostics devices) [F. No. X.11012/04/2025-DR] HARSH MANGLA, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification number G.S.R. 78 (E), dated 31st January,2017 and last amended vide notification number GSR 409 (E) dated 2nd June, 2023. 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.