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The Union ministry of health and family welfare is planning 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 has issued a draft notification with the proposed amendment, with a notice to the stakeholders that the draft rules shall be taken into consideration on or after the expiry of a period of 30 days from the date of publication of the draft. It has also invited objections and suggestions from the public within the specific period, for consideration.
The draft rules, which shall come into force on the date of their final publication in the Official Gazette, unless specified otherwise, propose addition of the qualifications for inspectors and government analyst for the sector, separately following the Rule 18 of the MDR, 2017.
The proposed Rule 18 A specifies the qualification of the inspector (medical devices), as a person who has a degree in 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; or with bachelors 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 mentioned in the recruitment rules for medical device officers in the Central Drugs Standard Control Organisation (CDSCO), notified in 2024, as part of strengthen the regulatory activities for medical devices in the country. In 2025, the Rules were once again amended to state that candidates with bachelors of engineering or technology in bio medical shall be considered instead of the previous norm for bachelors of engineering technology in bio medical to be considered for the post.
The latest draft proposes to add Rule 18B, specifying qualifications of government analysts for the medical devices. A person who has a degree in 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; or bachelors degree in pharmacy or pharmaceutical science or microbiology or bio- Chemistry or chemistry or life sciences from a recognised university or institute.
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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