Health Ministry Notifies New Qualification Norms for Inspectors, Government Analysts Under Medical Devices Rules

New Delhi: The Ministry of Health and Family Welfare has issued a notification to further amend the Medical Devices Rules, 2017, introducing specific qualification requirements for Inspectors and Government Analysts involved in the regulation of medical devices.

The notification, published in the Gazette of India, under G.S.R. 165(E), states that the amendments have been made in exercise of the powers conferred under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.

The ministry noted that a draft of these amendment rules was earlier published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide G.S.R. 748(E) dated October 10, 2025, inviting objections and suggestions from stakeholders within a period of thirty days from the date on which copies of the Official Gazette were made available to the public.

Copies of the Gazette containing the draft notification were made available on October 10, 2025. The Central Government confirmed that objections and suggestions received from the public were duly considered before finalizing the amendments.

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' postgraduate 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)

To view the official notice, click the link below: