Central Drugs Standard Control Organisation (CDSCO) has issued a circular on the licensing regimes of Class C & D non-notified medical devices. This circular was issued on 12th April, 2023.
The circular advises manufacturers/ importers to apply for grant of manufacturing/ import licences through the online system for medical devices. This application should be accompanied by requisite documents and fees as per Medical Device Rules, 2017 (MDR, 2017). This is intended to ensure a smooth transition from mandatory registration to licensing regime.
It may be recalled that as per MDR, 2017, for the grant of manufacturing licence for class C and D medical devices, the inspection needs to be carried out within 60 days from the date of application. Hence the application received will be processed proactively so as to be within stipulated timeframes to avoid disruptions in supply chains.