CDSCO Licensing Regime for Medical Devices
CDSCO (central Drugs Standard Control Organization) is responsible for the approval of and regulation of drugs, IVDs, medical devices, Control over the quality of imported devices, co -ordination of the activities with state drug control organization and providing advice to bring uniformity .As per the rule medical devices are categorized as Notified medical devices and Non-notified medical devices . As per CDSCO, There are 37 devices categorize under notified medical devices rule. Recently CDSCO issued guideline for Class A and Class B medical devices that ,the medical devices Class A and B will fall under the licensing regime in a year from now, on October 1, 2022, while Class C and Class D medical devices will come underneath the regime a year after that.
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The Guidance is issued for manufacturer and importer for voluntary and mandatory registration of medical devices. The registration of classes A, B, C and D medical devices has been kept voluntary for a length of 18 months with effect from April 1, 2020, until September 30, 2021. Currently Class A and Class B non -notified medical devices under mandatory Registration , they will be under licensing regime from October 01 ,2022 as per GSR 102 (E). CDSCO also specified the list of documents required by Manufacturer and the importer for the registration.
As per medical devices rule 2017, for Class A medical devices the audit to verify the QMS may be carried out within 120 days from the issuance of license by concerned SLA. For the smooth transition from registration to licensing regime, processing for issuance of license to the applicant of Class A and class b shall be initiated proactively so that licensure can be issued in stipulated time.
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Reference link – https://operonstrategist.com/resource/CDSCO_Update_2022.pdf
