The Ministry of Health and Family Welfare (MoHFW) on March 10, 2026, issued the Medical Devices (Amendment) Rules, 2026 to further amend the Medical Device Rules, 2017.
The following amendments have been stated:
• 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)
They shall come into force on March 10, 2026.
[Notification No. G.S.R. 165(E)]
