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The Union health ministry has notified an amendment to the Medical Device Rules (MDR), 2017, to incorporate the qualifications required for the recruitment of inspectors and government analysts for the medical devices vertical.
The Ministry issued a draft notification with the proposed amendment on October 10, 2025, inviting objections and suggestions from the public within the specific period, for consideration.
The Ministry, in the final notification earlier this month, said that it has considered objections and suggestions received from the public on the amendment.
The draft rules, which has already come into force with its publication in the Official Gazette, adds the qualifications for inspectors and government analyst in the medical devices sector, by amending the Rule 18 of the MDR, 2017.
The notification includes Rule 18 A under the Rule 18, to specify the qualification of the inspector (Medical Devices), as a person who has a 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 bachelor's degree in pharmacy or pharmaceutical science or microbiology or bio- chemistry or chemistry or life sciences from a recognised university or institute.
This was earlier covered under the recruitment rules for medical device officers in the Central Drugs Standard Control Organisation (CDSCO), as part of strengthening the regulatory activities for medical devices in the country.
The latest amendment also adds Rule 18B, specifying qualifications of government analysts for the medical devices. A person who has a degree in 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 a government analyst appointed under the Act, or 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).
Similarly, a person with a 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 either a government analyst appointed under the said Act, or 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), will also be qualified to be a government analyst for medical devices, under the amended rule.
The Ministry notified the MDR, 2017 on January 31, 2017, in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.
Medical devices, under the MDR, are classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices are required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
Manufacture of Class A and Class B medical devices are licenced by State Licensing Authorities concerned after Quality Management System audit by an accredited Notified Body. Manufacture of Class C and Class D medical devices are regulated by the Central Licensing Authority and, where required, assistance of experts or notified bodies will be taken. Import of all medical devices are regulated by the CDSCO.
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