An individual (importer or manufacturer) who wishes to import a small quantity of Class A/Class B/Class C/Class D of medical devices to India can obtain a Test license by Form MD-17. The test license can be used for the purpose of test, evaluation, demonstration, or training of medical devices. Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority of India that grants the test license for medical devices Form MD-17. The applicant who wants to obtain the test license should apply to the regulatory authority via Form MD-16 on an online portal Sugam. The applicant must upload the necessary documents and the required fee.
The application for a license to import medical devices to test, evaluate, demonstrate, train, or conduct clinical trials is obtained via this form.
The permission is granted by the CDSCO to import medical devices for test, evaluation, demonstration, training, or conduct clinical trials via this form.
Any person who imports in India can apply for Test License
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Sugam Registration of the applicant |
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Drafting of Application |
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Upload of document as per checklist of MD-16 |
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Processing of the Requisite Govt.Fee |
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Submission of Application on Online medical device portal |
100 USD per product is the prescribed fee for obtaining a test license in Form MD-17.
The test license is valid for three years.
The Government timeline is 30 working days
The applicant looking for permission to import medical devices must ensure these essentials are followed:
Quantity: The applicant must specify the quantity of medical devices to be imported during the submission.
Batch Details: The device's batch details, quantity to be utilized, and amount to be retained must be justified during the submission.
Other Details: The name of the place where testing, evaluation, demonstration, or training will be carried out should be mentioned during the submission.
Clinical Trial Details: If the test license is required for clinical investigation, the protocol of the clinical trials must be given.
After obtaining the test license, the individual must keep a record of all date and quantity of imported medical device and the manufacturer's name.
The license holder must keep a record of an invoice or statement that has details of the name and quantity of medical device imported.
The license holder must only use the medical device for the purpose it was imported.
Yes, the applicant can mention multiple sites in a single test license application for the test, evaluation, demonstration, training, or clinical investigation of the medical device.
The license holder can submit a written document to the Central Licensing Authority for the same.
The license holder can appeal to the Central licensing authority 45 days after cancellation of the license.
The following list of products are not regulated under MDR 2017:
