Clarification Letter / No Objection Certificate for Medical Devices in India


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    Unclear about the regulatory status of Medical Devices in India. Let CliniExperts’ professionals assist you for getting a Clarification Letter / No Objection Certificate (NOC) for Medical Devices from Central Drugs Standard Control Organisation.

    Clarification Letter For Medical Devices from CDSCO (NOC)– Overview


    The Central Drugs Standard Control Organization (CDSCO) has listed new regulations to obtain clarification on the regulatory status of the Medical Devices. To get this clarification, the importer or manufacturer must submit a no-objection certificate (NOC). The applicant should submit a hard copy of the NOC to the Medical Device division in CDSCO.

    Who Can Apply?


    Any Importer and local manufacturer can apply for Clarification NOC from CDSCO


    How To Apply?

    Hard Copy of application needs to be submitted at CDSCO. Below information needs to be covered during application submission.

     
    Product details/Description
    Regulatory Certificate from country of origin

    Fee Involved

    No fees will be required to obtain clarity regarding the regulatory status of the product

    Validity

    The validity of this is not specified.

    Important Documents

    To submit a NOC to the Medical Device division in CDSCO, the importer or manufacturer must also submit the following documents:

    The details or description of the Medical Device. A regulatory certificate from the country of origin of the Medical Device.

    Timeline to get Form NOC from Central Drugs Standard Control Organisation

    The Government timeline is not specified

    Essential Tips

    The importer or manufacturer must ensure that they have essential documents containing details of the Medical Device and the regulatory certificate from the country of origin of the Medical Device. As the timeline is not specified by the CDSCO, the application can take more than 30 days to process.

    Product details/ Description


    Regulatory Certificate from country of origin

    Expert Advise

    The importer or manufacturer should ensure that they have listed the exact intended use of the Medical Device as claimed in the instructions for use.

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    Frequently Asked Questions

    What does clarification NOC mean?

    A clarification NOC is a no-objection certificate issued by the CDSCO, which reflects the regulatory status of the Medical Device in India.

    Who are eligible for applying for clarification NOC?

    Both importers and manufacturers can apply for clarification NOC

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