Permission for Test License to Manufacture Medical Device (Form MD-12, Form MD-13)

Permission for Test License to Manufacture Medical Device (Form MD-12, Form MD-13)

Sometimes, pharmaceutical companies require to manufacture one or several medical devices in small quantities for the purpose of clinical investigation, test, evaluation, examination or training. The company must obtain a test license for manufacturing of medical devices for testing to the Central Licensing Authority.

Applications pertaining to all Class A, B, C and D medical devices shall the made only to the Central Licensing Authority. CliniExperts will help you in filing an application and obtaining a license from the Central Licensing Authority within the least possible time and minimum efforts.

Alongwith the application form MD-12, some other supporting documents have to be attached.

The first document is the cover letter, defining an overview of the application and its purpose. Further, a document defining the details of the medical device to be manufactured for testing has to be included with the application form.

A document describing the composition and working of the medical device in brief shall also accompany the application form. This helps the licensing authority understand the working of the medical device and if it is safe.

Further, the applicant should attach a document describing the purpose of the test medical device and how will it benefit the patient suffering from the respective ailment(s).

Finally, the applicant must provide a justification document, justifying the quantity of test medical device his/her company wants to manufacture. Failure in justification may lead to the rejection of the application, hence seeking the help of experts is wiser.

CliniExperts, will assist you in filing an online application for obtaining a license for your test medical devices. For more information on the same or any query, please feel free to reach us at or +91-767 20 05 050.

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