Test license to manufacture In Vitro Diagnostics in India – MD 12 & MD 13


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    Registration for in-vitro diagnostic medical devices for manufacturing can be time-consuming and tedious; we at CliniExperts will take care of all the registration procedures while you focus energies on planning your product launch. From the application process forms to undertaking a license test, we assist in every registration aspect to help you smoothly start the manufacturing process.

    Test license to manufacture In Vitro Diagnostic Kits (Form MD 12, 13)– Overview


    A medical device under Class A, B, C, or D can be manufactured in small quantities for various purposes; for instance, a medical device can be used for clinical investigation, testing, evaluation, examination, and demonstration or training. For manufacturing, any medical device, a particular set of procedures have to be followed, which is laid down by the CDSCO. The manufacturer has to apply to the Central Licensing Authority for approval concerning the guidelines of CDSCO. The Central Licensing Authority maintains the quality and standards for manufacturing any medical device as the highest regulatory body in the country. Any manufacturer who wishes to manufacture a medical device must apply to the Central Licensing Authority by submitting Form MD-12. The form states the purpose for manufacturing a medical device, which can be for testing, evaluation, demonstration, or training. The test license will be given in Form MD-13 by the online portal of the Ministry of Health and Family Welfare. The procedure duration can take up to 30 days for obtaining a test license

    What is MD 12 and MD 13

    Form Names

    MD-12

    The application form for taking license approval to manufacture a medical device for clinical investigation, test, evaluation, examination, demonstration, or training.

    MD-13

    The license to manufacture given by the Central Licensing Authority for manufacturing a medical device.

    Who Can Apply?


    Any person who wishes to manufacture small quantities of medical devices concerning the in-vitro diagnostic medical devices can apply to the Central Licensing Authority. The applicant has to state the purpose of manufacturing medical devices.


    How To Apply?

    The applicant must apply to the Central Licensing Authority by registering on the SUGAM portal.
    The applicant must apply with Form MD-12 with the required fees for each medical device.

    Fee Involved

    INR 500 for each distinct medical device.

    Validity

    Validity for test license to manufacture is 3 Years

    Important Documents

    The set of documents required for application of license are:
    A brief description of the In-vitro diagnostic kit which consists ofThe intended useThe material used for constructionThe design – Its labels and IFU

    Timeline to get Form MD 13 from Central Drugs Standard Control Organisation

    30 days

    Essential Tips

    The documentation of every manufacturing unit, with the manufacturer’s name, quantity specified, and date of the manufactured device, should be well recorded and kept with the holder of the test license


    For every consignment of medical device, an invoice or a statement should be generated with the name and quantity of the manufactured medical device.


    The approved test license should be used specifically for the clinical investigation, testing, evaluation, examination, demonstration, or training

    Expert Advise

    The holder of the test license shall maintain record of the activities undertaken including the name of manufacturer, quantity manufactured and date of manufacture

    The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of medical device.

    The Test license must be exclusively used for the purpose of clinical investigations, test, evaluation, examination, demonstration or training

    Frequently Asked Questions

    What is a Test License?

    The Test License is the approved license given by the Central Licensing Authority for manufacturing or importing small quantities of in-vitro diagnostic medical devices for clinical investigation, test, evaluation, demonstration, or training purposes

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

    Yes, you can mention multiple manufacturing sites by a single test license application intended for clinical investigation, testing, evaluation, demonstration, or training.

    Before introducing it in the market, is it necessary to conduct the PER for the test batch of medical IVD devices? How many samples are needed to be sent for PER?

    Yes, the applicant firm must obtain a license in Form-29 for developing three or more IVD product trial batches. A prescribed number of sample from three consecutive test batches of IVD medical devices have to be sent to the NIB (NOIDA) or the other notified laboratory. The PER must be sent to the CDSCO and the concerned State Drugs Control Authority

    What is the procedure if one wishes to move a medical device from one location to any other site which has not been specified in the Test License?

    In such scenarios, the applicant shall inform the Central Licensing Authority before relocating the medical device.

    Within how many days can the suspended licensee appeal to the authority for cancellation of suspension?

    After the suspension of the test license, the manufacturer/licensee can appeal to the authority within forty-five days from the date of a suspension order.

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