Non-Notified Medical Devices Registration/ Approval in India


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    CliniExperts acts as an authorized representative to help you in getting the permission to import non-notified medical devices in India. Register your Non-notified Medical Devices in India with CliniExperts' professional assistance.

    Registration Number for Non-Notified Medical Devices– Overview


    The regulatory body of India has laid down provisions for non-notified medical devices. The products already under the notified category of the medical device are excluded from this category. Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority of India that grants the Registration for non-notified medical devices. As per the provisions, an individual who wishes to obtain the registration number of non-notified devices needs to file an application via an online portal of Sugam.

    Who Can Apply?


    Any Importer and local manufacturer can apply for the Registration of non-notified Medical Devices


    How To Apply?

    Steps to be Followed by the manufacturers/importers for Registration of Non-Notified Medical Devices.
    Follow the URL https://cdscomdonline.gov.in/NewMedDev/Homepage
    Applicant has to click on the registration link from the portal.
    Applicant has to register with a valid Email-id and Mobile No.
    The applicants has to upload the following documents for registering on the portal:-
    • Id Proof Details
    • Undertaking
    • Corporate Address Proof Details (Certificate of Incorporation)
    • Copy of Manufacturing License and the Wholesale Licenses (If not then upload the justification for the same)
     
    The applicant has to verify the registration through the OTP (4 digits) received on the mobile, after verification the applicant can login and proceed further.
    Applicants need to upload the relevant documents as per the Registration Number checklist.

    Fee Involved

    Government fee is not applicable to obtain voluntary registration number.

    Validity

    The Registration for class A and class B medical devices would be valid till Sep 2022, and class C and class D medical devices would be valid till Sep 2023.

    Important Documents

    Free Sale Certificate from country of origin if the product will be imported and ISO 13485 certificate. Free Sale Certificate from country of origin in case of Import only. ISO 13485 certificate in case of import and manufacturing both. Details of the medical device include intended use, construction material, accessories/component dimension, sterilization, and shelf life.

    Timeline to get Form from CDSCO

    The Government timeline is not specified

    Essential Tips

    The applicant looking to obtain a voluntary registration number must ensure these essentials are followed:

    The applicant must have a Free Sale Certificate in case of import and an ISO 13485 Certificate.


    If the regulatory status of the medical device has not been justified, clarity should be obtained from the regulatory authority. This needs to be done before the VRN application.


    The medical device needs to be classified in the class if it is not specified by the regulatory body.

    Expert Advise

    After the expiry of voluntary registration number validity, the rules of import or manufacturing license might apply.

    The importer or the manufacturer of the medical device must comply with the safety and quality requirements of the product.

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    Frequently Asked Questions

    Does the importer or manufacturer need to have an ISO 13485 Certificate?

    Yes, an ISO certificate is compulsory.

    Who is eligible to apply for a Voluntary Registration Number?

    Both importer and manufacturer can apply for the voluntary registration number.

    Where can an individual check the risk class of a non-notified device?

    An individual can check the CDSCO Classification List to check the risk class of a non-notified device.

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