The Central Drugs Standard Control Organization (CDSCO) on April 12, 2023, issued a circular regarding licensing regime of Class C & D non-notified medical devices which are currently under mandatory registration.
It is stated that for the grant of manufacturing license of Class C and D medical devices, the inspection needs to be carried out within 60 days from the date of application by the Medical Devices Officers (MDO) of Central Licensing Authority (CLA), to ensure the compliance with Fifth Schedule of MDR 2017.
In order to have a smooth transition from mandatory registration to the licensing regime, it is suggested that the manufacturers/importers may apply for a grant of manufacturing/import license with all requisite documents and fees as per MDR 2017, through www.edscomdonline.gov.in portal.
[File No. 29/Misc/03/2022-DC (94)]
