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Test License

Test license is issued in order to manufacture and import small quantity of medical devices or in-vitro diagnostic devices for the purpose of testing, clinical investigation, examination, demonstration or training.

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Test license for Manufacturing

When there is a requirement of small quantity of Class A or Class B or Class C or Class D of medical devices for the purpose of test, evaluation, examination, clinical investigations, demonstration or training.

  • Form MD-12:

The application for the test license for manufacturing devices is to be made in Form- MD 12 to the central licensing authority i.e. CDSCO also known as Indian FDA, accompanied with fees.

  • Form MD-13:

The CDSCO shall review the test license application and shall grant a test license in Form MD-13 or CDSCO may reject the application if it is not satisfied with the submitted documentation.

Test License for Import

To import small quantities of medical devices or in-vitro diagnostic medical device may be imported for the purpose of clinical investigation, testing, evaluation, demonstration or training, test license for import is required.

  • Form MD-16:

The application for import test license shall be made to CDSCO in Form MD- 16 accompanied with fee payment.

  • Form MD-17:

The test license for import is granted in Form- MD 17 by the central licensing authority or may be rejected.

Maven Profcon Services LLP., can assist you in compilation of documents for application of test license and solve the queries.

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