CDSCO Test Licence for Medical Devices (MD-13 and MD-17)

A CDSCO test licence allows you to manufacture or import medical devices and IVDs in limited quantities for testing, evaluation, clinical investigation, demonstration or training, not for sale. Medfins International prepares the MD-12 or MD-16 application, justifies the quantities, and sets up the record keeping you need so the test licence supports, rather than delays, your main licence.

What is a CDSCO test licence?

The Medical Devices Rules, 2017 provide a separate licence for devices that are made or imported only for non-commercial purposes such as clinical investigation, test, evaluation, examination, demonstration or training. The CDSCO test licence is granted by the Central Licensing Authority and covers a stated quantity of each device for the stated purpose.

There are two routes:

• Test licence to manufacture: application in Form MD-12, licence granted in Form MD-13.
• Test licence to import: application in Form MD-16, licence granted in Form MD-17.

A test licence is generally valid for three years from issue, unless suspended or cancelled. Devices made or imported under it must not be sold.

Who needs a test licence?

• Indian manufacturers building prototypes or pilot batches for performance and safety testing before applying for a CDSCO manufacturing licence.
• Importers bringing in samples for testing at a CDSCO-registered laboratory as part of an import licence application.
• Sponsors and investigators conducting clinical investigations or clinical performance evaluations.
• Companies importing units for demonstrations, training or evaluation by hospitals and institutions.
• Research groups and start-ups developing new devices and IVDs.

Scope and classification

Test licences are available for devices of all risk classes. The purpose, however, must be specific and credible. CDSCO expects the application to show why each device is needed, where it will be used and how many units are required. Where a clinical investigation is involved, the test licence runs alongside a separate permission for the investigation itself (Forms MD-22 and MD-23 for devices, or MD-24 and MD-25 for clinical performance evaluation of new IVDs).

Documents required

Requirements vary with the purpose, but a typical application includes:

• Form MD-12 or MD-16 with proof of fee payment as per the Second Schedule.
• Description of the device, its intended use and risk class.
• Statement of purpose and a justification of the quantity requested.
• Details of the testing laboratory, investigation site or training venue.
• Test protocol or clinical investigation plan, where applicable.
• For import: details of the overseas manufacturer and, where relevant, its regulatory status.
• For manufacture: details of the premises and facilities where the samples will be made.
• Draft labels showing that the device is for test, evaluation or investigation only.

Government fees

Fees are set in the Second Schedule and are charged per distinct device. As per the rules, the fee is typically INR 500 per distinct device for a manufacturing test licence and USD 100 (or its equivalent in rupees) per distinct device for an import test licence. We confirm the current amount at the time of filing, since fee schedules can be revised by amendment.

Step-by-step process

1. Define the purpose: testing, evaluation, clinical investigation, demonstration or training.
2. Calculate and justify quantities based on test standards, sample plans or protocol requirements.
3. Prepare the application and supporting documents for the manufacture or import route.
4. File online on the CDSCO portal and pay the prescribed fee.
5. Respond to queries from the Central Licensing Authority.
6. Receive the MD-13 or MD-17 licence and use it only for the approved purpose.
7. Maintain records of quantities made or imported, used, tested, returned or destroyed.

Timelines and what affects them

Test licence applications are usually less complex than full licence applications, but they are not a formality. The time taken depends on how clearly the purpose is explained, whether the quantity is well justified, and how quickly queries are answered. For imports, allow time for shipping and customs clearance after the licence is granted, and make sure the test laboratory is ready to receive the samples.

A useful rule is to plan the test licence as part of the overall regulatory programme. Samples imported under an MD-17 licence often feed directly into testing required for the main application, so a delay here shifts every later milestone.

Common reasons for queries and delays

• Vague purpose statements such as “for evaluation” without naming the tests or site.
• Quantities that are higher than the testing or protocol plan can explain.
• Missing details of the laboratory or clinical site.
• Labels that do not state clearly that the devices are not for sale.
• Poor records of use and disposal, which cause problems at inspection or when renewing.

Obligations after grant

The licence holder must use the devices only for the approved purpose and keep accurate records of every unit. Unused devices must be dealt with as the licence conditions require, for example by destruction under record or return. CDSCO may inspect records, and sale of test-licence devices is a breach of the Drugs and Cosmetics Act, 1940.

How Medfins International supports you

Medfins International has supported more than 100 clients across over 250 medical device products, many of which needed samples tested before the main approval. Our test licence support covers:

• Choosing the correct route (MD-12/MD-13 or MD-16/MD-17) and purpose.
• Preparing quantity justifications linked to test standards or protocols.
• Drafting the application, labels and cover letters, and filing online.
• Coordinating with testing laboratories and your logistics team.
• Setting up simple logs so your records stand up to inspection.

Overseas manufacturers usually need an Indian authorised agent in place for import. To plan your test licence, get in touch with our team.

Frequently asked questions