Manufacturers and importers of Class C and D non-notified medical devices directed to apply for grant of manufacturing / import license through ‘Online System for Medical Devices’ portal

With a view to ensure smooth transition from the current mandatory registration to licensing regime, the Central Drugs Standard Control Organisation (CDSCO) has directed manufacturers and importers of moderate high risk (Class C) and high risk (Class D) medical devices to apply for grant of manufacturing or import license with all requisite documents and fees as prescribed under the Medical Devices Rules, 2017, through the Online System for Medical Devices portal.

Further, it has been reiterated by CDSCO that there is a requirement for an inspection within 60 days of the application by Medical Device Officers (MDO) of the Central Licensing Authority (CLA) to ensure compliance with Fifth Schedule of Medical Devices Rules, 2017.

Applications received will be processed proactively, so that licensure can be issued within the stipulated timeline in order to avoid any disruption of the supply chain of such medical devices and access to the patients.

A copy of the Circular is linked below for ease of reference.

Source: Ministry of Health and Family Welfare