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  • 1.  CDSCO Registration for Class A SaMD

    Posted 30-Mar-2023 02:33

    Hello,

    I wanted to understand the certifications required for registering a Class A SaMD with CDSCO. Is ISO 13485 Certificate sufficient? Please suggest.

    Thank you,

    Sujata



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    Sujata Dutta Gupta
    Quality Manager
    Chennai
    India
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  • 2.  RE: CDSCO Registration for Class A SaMD

    Posted 30-Mar-2023 03:06

    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. However, the registration must be done by submitting the undertakings. 

    https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA0MQ==

    For Class A devices outside this category, full registration must be done. 

    In terms of certification, please follow the essential principles checklist as specified in Fourth Schedule Appendix II 

    https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDU3

    If additional certificates are needed to prove conformity, you may need to have them ready during the notified body inspection.



    ------------------------------
    Nilesh Rajule, PhD

    linkedin.com/in/nileshr
    Bangalore, India
    ------------------------------

    Original Message


  • 3.  RE: CDSCO Registration for Class A SaMD

    Posted 30-Mar-2023 03:40
    Hello Ms. Sujata, 

    Mostly the SaMD are classified into B Category as per CDSCO. So please verify that. 

    For Class B the general documents required are:

    1. ISO 13485
    2. Manufacturer details/Importers details (Name, address, contact details etc.)
    3. Incorporation of Company details
    4. Free Sale certificate from the country of Origin. 
    5. Power of Attorney

    And a Wholesale Drug Licence in case of Manufacture Licence. 



    Original Message


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