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