The Central Drugs Standards Control Organisation on 14th October 2021, has requested the private laboratories which have capacity for testing of medical devices and are NABL accredited and interested to be registered shall intimate to CDSCO at dci@cdsco.nic.in and ddcimd-cdsco@nic.in along with details of categories of such medical devices and capacities and capabilities of testing to CDSCO.
CDSCO has taken the above move to enhance the testing capacity of medical devices in the country identification registration and empanelment of government private testing laboratories for medical device testing which is under consideration as per medical devices rules 2017.
Medical devices will, under the new Rules, be classified as per Global Harmonisation Task Force (GHTF) practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
