The Central Government had earlier published draft rules to amend the Medical Devices Rules, 2017 through notification G.S.R. 748(E) dated October 10, 2025, inviting objections and suggestions from stakeholders within thirty days from the date copies of the Gazette were made available to the public. Copies of the draft notification were made available on October 10, 2025. The objections and suggestions received were considered by the Central Government before finalising the amendment.

In the Medical Devices Rules, 2017, after Rule 18, the following rules are inserted:

“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).”