August 28, 2022
Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of devices on behalf of device manufacturers applying for Indian market registration.
The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has now identified 24 total MDTLs to provide testing and evaluation according to the Medical Device Rules, 2017. The list identifies which device types each particular MDTL is qualified to test, so manufacturers seeking to register their products in India may consult the list to see which entities are best suited to evaluate their devices.
The CDSCO last updated the list of qualified MDTLs in May 2022. Under the Medical Device Rules, 2017, Indian medical device market registrants must submit their products for MDTL testing as part of the registration process.