The Central Drugs Standard Control Organisation has issued a notice on registration of medical devices as per Medical Device Rules (MDR) 2017. Medical Device Testing Laboratories are to be registered in form MD-40 for Testing of Medical Devices on behalf of the manufacturer.
The government noted that as on 22nd December 2022 it has registered more than 28 medical device testing laboratories. The list of these labs are available on the CDSCO website.
The government Is now seeking to identify, register and empanel government private testing laboratories for medical devices. In doing so, it seeks to enhance the testing capacity of medical devices in the country.
Hence, laboratories that have the capacity to test medical devices and are NABL accredited are requested to submit the application in Form MD-39. This application shall be accompanied by with requisite fees and documentation. The application shall be submitted online for taking further necessary action.
