On 7 March last, the Central Drugs Standard Control Organization (CDSCO) issued Notice No.29/Misc/03/2019-DC (211) List of the certified Medical Device Testing Laboratory (MDTL) under MDR 2017 which includes the list of accredited laboratories (Medical Device Testing Laboratory or MDTL) for performing pre-clinical safety testing and evaluation on Medical Devices and In Vitro Diagnostic Medical Devices, under Article 81 of the Medical Device Rule 2017 which came into force on 1 January 2018.
Within the list is all the information necessary to identify the accredited laboratory in charge of performing the tests for the purpose of device registration with CDSCO, such as name, laboratory address and registration number.
The document identifies the criteria for identifying the test facility, the categories of devices handled, the limitations inherent to the risk class, and the type of test for which accreditation applies (e.g. biocompatibility, sterilisation, physical and mechanical tests, bioburden) together with the reference standard.
These laboratories, which are the only ones authorised to test devices for registration purposes, are accredited to the National Accreditation Board for Testing and Calibration Laboratories (NABL).
It is important to specify that an application made to CDSCO is not a sufficient condition to be on the list, but it is essential to also be NABL-accredited. To date, CDSCO has only authorised 30 laboratories spread all over India to support the manufacturer in performing safety tests and device evaluation.
Performing safety testing and pre-clinical evaluation by accredited laboratories (all based in India) entails a significant investment for Manufacturers based outside the country, if one considers the costs due to the execution of recognised verifications by the Regulatory Authority on site and the need to send representative samples to the country for verification, with the consequent need to manage the import process.
>> With Thema’s strategic-regulatory consulting services, specialist support for ministerial registration and Local Representative in India, Thema can assist you in fulfilling the requirements of Indian regulation.
Contact us! We will be happy to help you.
Sources:
