Medical Devices (Amendment) Rules, 2023


The Ministry of Health and Family Welfare has introduced the Medical Devices (Amendment) Rules, 2023. These Amendment Rules were notified on 2nd June, 2023 and come into effect from that date. These Rules aim to enhance the regulatory framework governing medical devices in the country. They provide for the establishment and designation of State Medical Devices Testing Laboratories, further empowering the testing and evaluation of medical devices.

The Amendment Rules define the term “State Medical Devices Testing Laboratory” as a “laboratory established or designated by the State Government under sub-rule (3) of Rule 19.

Additionally, the Amendment also grants both the Central and State Governments the authority to regulate medical devices in their respective jurisdictions.

Furthermore, various modifications have been made to improve the functioning of Medical Device Testing Laboratories as follows:

  1. the marginal heading of the rule has been revised to “Medical Device Testing Laboratories” for clarity.
  2. the State Government has been granted the power to establish State Medical Devices Testing Laboratories for testing and evaluating medical devices. These laboratories may also be designated by the State Government if they possess the necessary facilities for conducting tests and evaluations. However, accreditation by the National Accreditation Body for Testing and Calibration Laboratories is a prerequisite for designation.

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