Test license to Manufacture Medical Devices in India – MD 12 & MD 13


ENQUIRE NOW


    CliniExperts dedicated team helps in getting the Permission For Test License To Manufacture Medical Devices. We strategically plan the process for regulatory approval of manufacturing test license for medical devices in Form MD 13.

    Test license to Manufacture Medical Devices (Form MD 12, 13)– Overview


    In India, small quantities of Class A, Class B, Class C, or Class D medical devices may be manufactured by procuring a Test License in Form MD-13 issued by CDSCO. These devices can be used for the purpose of clinical research, testing, evaluation, demonstration, or training.

    A person who intends to manufacture a medical device must apply for a Test license by filling out a Form MD-12 from an identified online portal of the Ministry of Health and Family Welfare for the purpose of test, evaluation, demonstration, and training. The Ministry of Health and Family Welfare will then issue a Test license in the Form MD-13.

    CDSCO - Authorized Agent Support - Medical Device

    What is MD 12 and MD 13

    Form Names

    Form MD12

    Application for obtaining the license to manufacture medical devices for the purpose of conducting clinical investigations, evaluation, tests, examination, training or demonstration.

    Form MD13

    License to manufacture medical devices for the purpose of conducting clinical investigations, tests, evaluation, demonstration or training.

    Who Can Apply?


    Any person who wishes to manufacture medical devices for testing purpose can apply for Form MD 13.


    How To Apply?

    The application is done with reference to MDR 2017. Registration on the Sugam portal is mandatory for applying for the test license

     
    Step 1: Register the applicant on Sugam portal
    Step 2: Draft application
    Step 3: Upload mandatory documents as per check list of MD-12
    Step 4: Payment of Requisite government fee
    Step 5: Submit the application on online medical device portal

    Fee Involved

    INR 500 is the fees to be paid while filling the form.

    Validity

    The validity for the Test License is 3 Years

    Important Documents

    Brief description of the medical device to be manufactured including intended use, material of construction, design, etc. List of Qualified personnel Quality certificatesList of equipmentSchematic plan of premises

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

    Government Timeline for Test License to manufacture Medical Device is 30 working Days

    Essential Tips

    The quantity to be manufactured must be justified and clarified during the submission process.


    The name of the place where demonstration, testing, evaluation, clinical trials or training will be conducted should be finalized in the submission preparation process.


    The specifications of the product, such as material, intended use, and description, must be submitted during the process.


    It is important to justify the quantity to be manufactured by providing batch details, quantity to be used, and quantity to be retained.


    The test protocol or clinical investigation plan is a crucial requirement when applying for a test license for clinical investigation purposes.

    Expert Advise

    The licensee must keep a record of the quantity and disposition of medical devices manufactured, tested, and stocked.

    Test licenses must be used exclusively for the purpose for which they were obtained.

    Related Services

    Frequently Asked Questions

    Is it possible to mention multiple sites in a single test license application for the purpose of Clinical Investigation, Testing, Evaluation, demonstration, and training?

    Yes. It is possible to list multiple sites where the training or testing is going to be conducted in the same application form.

    In cases where the medical device has to be transported somewhere else, how can this be accomplished with the ones mentioned in the test license?

    In such case, the Central Licensing Authority should be informed in writing before proceeding

    Does CDSCO inspect the Test manufacturing facility?

    Yes, Medical Device Officers may enter the facilities where the medical devices are manufactured, with or without notice, to verify that only clinical investigations, tests, evaluations, examinations, demonstrations, and training are conducted on those devices that have received due Test License.

    In how many days should an applicant may apply to CDSCO in case license has been cancelled?

    A licensee, whose license has been cancelled, must appeal to the Central Government within forty-five days from the date of the order to re-apply for the same license. After this, the license will be permanently cancelled.

    Call Now