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Hi Barry, Medical devices can be grouped under these categories in India- Single Family In Vitro Diagnostic (IVD) Test Kit System IVD Cluster Group You can find the grouping guidelines in this document. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guid ...

Release date 15 Feb 2023 [GSR 78(E), dt. 31-1-2017, w.e.f. 1-1-2018] (As amended vide GSR 777(E) dt. 14-10-2022(w.e.f. 14-10-2022)

Hello Sujata, Please ensure that SaMD is listed as Class A in software category notification from CDSCO. The ISO 13485 certificate is needed for the import license.  If you are applying for a manufacturing license -  Non-sterile non-measuring class A devices are exempted from full licensing. ...

Hello Priya, There is no guidance on the time interval to update the Plant Master File (PMF).  Since this document is included along with the Quality Manual requirements, it needs to stay current. This means the change management should take care of the update in PMF along with Quality Manual. ...

Please checkout this post for more info - https://connect.raps.org/discussion/watsapp-group#bm2b690f4b-5ce4-4e4c-bd81-0187081d4805 ------------------------------ Nilesh Rajule, PhD linkedin.com/in/nileshr Bangalore, India ------------------------------