The Ministry of Health and Family Welfare has published a draft notification proposing amendments to the Medical Device Rules, 2017, to formally establish the minimum educational qualifications required for personnel appointed as Inspectors and Government Analysts specifically for medical devices.
The proposed amendments, titled the Medical Devices (Amendment) Rules, 2024, aim to ensure that regulatory and quality control functions are performed by individuals with appropriate technical and scientific backgrounds relevant to the medical device industry.
Proposed Qualifications for Medical Device Inspectors (New Rule 18A)
A person appointed as an Inspector (Medical Device) under the Drugs and Cosmetics Act, 1940, must hold a degree in one of the following:
Engineering/Technology: Bachelors of engineering technology in Bio Medical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Bio-Technology, Polymer, Computer Science, or Medical Electronics Engineering from a recognized university or institute; OR
Science/Pharmacy: Bachelors degree in Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university or institute.
Proposed Qualifications for Government Analysts (New Rule 18B)
The exact same set of qualifications is proposed for a person appointed as a Government Analyst under the Act:
- Engineering/Technology: Bachelors of engineering technology in Bio Medical, Chemical, Mechanical, Electrical, Electronics, Instrumentation, Bio-Technology, Polymer, Computer Science, or Medical Electronics Engineering from a recognized university or institute; OR
- Science/Pharmacy: Bachelors degree in Pharmacy, Pharmaceutical Science, Microbiology, Bio-Chemistry, Chemistry, or Life Sciences from a recognized university or institute.
Public Consultation
The draft rules are now open for public feedback and suggestions for a period of thirty days from the date the official Gazette copies are made available. Objections or suggestions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.