Manufacturers of medical devices directed to apply for manufacturing license for devices through online portal ; Quality certificates from other entities not replacement for license : CDSCO
The Central Drugs Standard Control Organization (“CDSCO”) has notified that quality certificates issued to the manufacturers under the Medical Devices Rules, 2017 will have to be derived from the Competent Licensing Authority under the Medical Devices Rules, 2017. It is further clarified that the quality certificates issued by other authorities cannot be a replacement of the licensures granted under the Medical devices rules, 2017 by the authorised licensing authority.
Given that all non-notified medical devices pertaining to Class A and Class B categories are scheduled to enter the licensing regime by October 2022, all manufacturers are required to apply for manufacturing license for Class A and Class B medical devices through CDSCO’s online portal so that the manufacturing license can be granted by respective state licensing authorities after review of the applications as per the stipulated time-period in Medical Devices Rules, 2017.
Background: CDSCO noticed some other entities issuing quality certificates to the manufacturers leading to confusion for manufacturers regarding obtaining the licensure of such medical devices under the Medical Devices Rules, 2017
(Note: All manufacturers will have to comply with the licensing requirement and obtain the license as per Medical Devices Rules, 2017)
