Licensing Regimes of Class C & D non-notified Medical Devices


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.

Leave a Reply

Your email address will not be published. Required fields are marked *

Fill in the form

    Labour LawsEnvironment, Health and SafetyDirect Tax lawsIndirect tax laws (GST/ Customs / VAT)Corporate Laws (Company Law, SEBI & FEMA)Food Safety LawsFinancial Service sectorInsurance SectorHealthcare SectorOther ancillary laws

    Do you want GST Refund ?

      Get In Touch

        Get Bulk Subscription