India’s Central Drugs Standard Control Organization is requiring laboratories that test medical devices and in vitro diagnostics to register with the agency.
The registrations will allow CDSCO and other government agencies to maintain updated information on all laboratories involved in testing of medical devices and IVDs.
CDSCO issued the order in light of the country’s new Medical Device Rules that became effective Jan. 1, marking the first time that India regulated medical devices separately from drug products.
Under the new rules, the Central government may designate any laboratory that has facilities for testing and evaluating devices and IVDs as a central medical device testing laboratory. However, no laboratory may be designated without first being accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
Laboratories that go through the accreditation process will need to inform CDSCO about which devices and IVDs can be tested at their facilities, as well as the persons involved in the testing. Laboratories that are deemed suitable may be officially designated as central medical device testing labs.
Applicants for the central medical device testing laboratory designation should send a valid copy of the NABL certificate to CDSCO along with the scope of the test for which it is accredited, a copy of the testing protocol and test method for each of the test parameters, and a list of equipment with calibration status and manufacturer details.
India will soon release a new national list of IVDs that could be used to improve access to reliable diagnostic tests in public hospitals for high burden diseases such as HIV, tuberculosis and malaria, according to the Indian Council of Medical Research.
The list could be expanded later to create a list of essential diagnostics, similar to India’s list of essential drugs, which could be used to set price caps.
Earlier this month, India released final audit fees for notified bodies under its new medical device regulations (IDDM, March 5).
Read the CDSCO notice here: www.fdanews.com/03-13-18-Indialabs.pdf.