DCGI Grants registration to Laboratory for testing Medical Devices, in vitro diagnostics on behalf of manufacturer

New Delhi: In a bold attempt to enhance in vitro diagnostics (IVDs) and medical device quality, safety, and performance, through the recent circular, the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO), the Drugs Controller General of India (DCGI) has notified all industry participants, including testing facilities and medical device/in vitro diagnostics manufacturing associations, that registration has been granted to laboratories with the goal of testing or evaluating medical devices on behalf of manufacturers.
This initiative, enacted under Chapter X of the Medical Device Rules (MDR) 2017, aims to bolster the country's testing facilities and ensure compliance with rigorous standards.
Additionally, the DCGI highlighted that medical device samples must meet the Bureau of Indian Standards (BIS) for performance and quality, and as a result, the devices must be tested in accordance with the specifications outlined in the BIS standards. Only additional standards listed in Rule 7 of the MDR may be used in the absence of a BIS standard.
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