Health Ministry Draft Rules: Only Engineering or Pharmacy Graduates Eligible to Become Medical Device Inspectors, Analysts
New Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare (Department of Health and Family Welfare) has issued a draft notification proposing amendments to the Medical Device Rules, 2017, introducing new qualification requirements for Inspectors and Government Analysts engaged in medical device regulation and quality testing.
The draft, published in the Gazette of India (G.S.R. 748(E)) on October 10, 2025, was issued under Sections 12(1) and 33(1) of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board (DTAB).
The proposed amendments, titled the Medical Devices (Amendment) Rules, 2024, invite objections and suggestions from the public within 30 days from the date copies of the Gazette are made available. Responses may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Room No. 545, A-Wing, Nirman Bhavan, New Delhi – 110011, or via email at drugsdiv-mohfw@gov.in
According to the draft, two new rules—Rule 18A and Rule 18B — are proposed to be inserted after Rule 18 in the Medical Device Rules, 2017, specifying the educational qualifications required for regulatory personnel in the medical devices sector.
Rule 18A lays down the Qualifications of Inspector (Medical Device), while Rule 18B prescribes the Qualifications of Government Analyst.
Under both provisions, eligible candidates must possess a Bachelor’s degree in engineering or technology in disciplines such as Biomedical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Biotechnology, Polymer, Computer Science, or Medical Electronics Engineering, or a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Microbiology, Biochemistry, Chemistry, or Life Sciences from a recognized university or institute.
The notification specifies, "These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette."
The Gazette notification finally declared:
“In the Medical Devices Rules, 2017, after Rule 18, the following rules shall be inserted, namely:—18A. Qualifications of Inspector (Medical Device)— A person who is appointed as an Inspector under the Act shall be a person who has a degree in—i. Bachelors of engineering technology 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; orii. Bachelors degree in Pharmacy or Pharmaceutical Science or Microbiology or Biochemistry 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 degree in—i. Bachelors of engineering technology 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; orii. Bachelors degree in Pharmacy or Pharmaceutical Science or Microbiology or Bio-Chemistry or Chemistry or Life Sciences from a recognised university or institute.”
To view the official order, click the link below:
