To ensure the quality, safety, and performance of Medical Devices (MDs) and In Vitro Diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India, has authorized the registration of laboratories for testing and evaluating medical devices on behalf of manufacturers. This initiative, under Chapter X of the Medical Device Rules 2017, aims to strengthen the country’s testing facilities.

It is important to note that with the implementation of the Medical Device Rules (MDR) 2017 effective from January 1, 2018, the Drug Rules 1945 are no longer applicable to MDs/IVDs. Additionally, the product standards for medical devices, as stipulated under Rule 7 of the MDR, are now mandatory. 
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