On 2-6-2023, the Ministry of Health and Family Welfare notified the Medical Devices (Amendment) Rules, 2023 to amend the Medical Devices Rules, 2017. The provisions came into force on 2-6-2023.
Key Points:
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In Rule 3, the definition of “State Medical Devices Testing Laboratory” has been inserted.
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Earlier, Rule 19 used to focus only on the Central Medical Device Testing Laboratory but now the heading has been revised to Medical Device Testing Laboratories which now includes State Laboratories.
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Rule 19(3) has been inserted which focuses on the purpose of establishing State Medical Devices Testing Laboratory:
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testing and evaluation of medical devices
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to carry out any other function as may be specifically assigned to it.
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Rule 19(4) has been inserted which says that the State Government can also designate any laboratory having facility for carrying out test and evaluation of medical devices as State Medical Devices Testing Laboratory if has been duly accredited by the National Accreditation Body for Testing and Calibration Laboratories.