Test License for Medical Devices in India – Form MD 16 & MD 17


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    Need a permission to import medical device in India to demonstrate its performance? CliniExperts’ professionals have expertise and assist you in securing a medical devices test license for importers in Form MD 17 by CDSCO.

    Permission To Import Test License For Medical Devices (Form MD 16, 17)– Overview


    An individual (importer or manufacturer) who wishes to import a small quantity of Class A/Class B/Class C/Class D of medical devices to India can obtain a Test license by Form MD-17. The test license can be used for the purpose of test, evaluation, demonstration, or training of medical devices. Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority of India that grants the test license for medical devices Form MD-17. The applicant who wants to obtain the test license should apply to the regulatory authority via Form MD-16 on an online portal Sugam. The applicant must upload the necessary documents and the required fee.

    What is Form MD 16 and MD 17

    Form Names

    MD-16

    The application for a license to import medical devices to test, evaluate, demonstrate, train, or conduct clinical trials is obtained via this form.

    MD-17

    The permission is granted by the CDSCO to import medical devices for test, evaluation, demonstration, training, or conduct clinical trials via this form.

    Who Can Apply?


    Any person who imports in India can apply for Test License


    How To Apply?

    Sugam Registration of the applicant
    Drafting of Application
    Upload of document as per checklist of MD-16
    Processing of the Requisite Govt.Fee
    Submission of Application on Online medical device portal

    Fee Involved

    100 USD per product is the prescribed fee for obtaining a test license in Form MD-17.

    Validity

    The test license is valid for three years.

    Important Documents

    The description of the in vitro diagnostic kit or medical device The description must include materials of construction, intended use, design label, and instructions for the use of the medical device.

    Timeline to get Form MD 17 from CDSCO

    The Government timeline is 30 working days

    Essential Tips

    The applicant looking for permission to import medical devices must ensure these essentials are followed:

    Quantity: The applicant must specify the quantity of medical devices to be imported during the submission.


    Batch Details: The device's batch details, quantity to be utilized, and amount to be retained must be justified during the submission.


    Other Details: The name of the place where testing, evaluation, demonstration, or training will be carried out should be mentioned during the submission.


    Clinical Trial Details: If the test license is required for clinical investigation, the protocol of the clinical trials must be given.

    Expert Advise

    After obtaining the test license, the individual must keep a record of all date and quantity of imported medical device and the manufacturer's name.

    The license holder must keep a record of an invoice or statement that has details of the name and quantity of medical device imported.

    The license holder must only use the medical device for the purpose it was imported.

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    Frequently Asked Questions

    Can the applicant mention multiple sites in a single test license application?

    Yes, the applicant can mention multiple sites in a single test license application for the test, evaluation, demonstration, training, or clinical investigation of the medical device.

    How can the license holder carry the medical device to a place not specified in the test license?

    The license holder can submit a written document to the Central Licensing Authority for the same.

    If the Central licensing authority cancels the license, when can the license holder appeal to the authority?

    The license holder can appeal to the Central licensing authority 45 days after cancellation of the license.

    Which products are not regulated under MDR 2017?

    The following list of products are not regulated under MDR 2017:

    • Research Use Only
    • Q.C material for accreditation
    • Panel for Q.C testing
    • Product used for food, water, sterility testing used by various industries for Q.C
    • Microbiological culture media
    • Stains indicators
    • Reagents used for food and water testing.
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