What is a CDSCO Test License? Procedure, Fees & Requirements for 2025

Understanding the CDSCO Test License

A CDSCO Test License is a formal authorization that allows manufacturers, importers, or research organizations to import or manufacture medical devices for testing or evaluation, clinical investigation, or demonstration purposes.

It is not meant for commercial sale, but rather to verify the safety, performance, and compliance of a device before full-scale production or market approval.

In India, this license is issued under:

• Form MD-16 (for import of medical devices for testing)

• Form MD-17 (for the manufacture of medical devices for testing)

Why is the Test License CDSCO Important?

The test license from CDSCO assures:

• Devices are tested according to Indian regulatory standards.

• Product performance and safety are verified before commercial launch.

• Companies comply with the Medical Device Rules, 2017.

• It supports faster approval when applying for manufacturing or import licenses later.

Without this license, importing or testing unapproved devices can lead to penalties, product seizure, or rejection of future applications.

Checklist for Test License CDSCO Application

Applicants should have prepared the following documents and information before applying for the CDSCO testing license for the medical devices:

Mandatory Documents

1. Covering letter stating the purpose of the license.

2. Copy of the manufacturing/ import license (if applicable).

3. Device master file and plant master file.

4. Details of testing, evaluation, or clinical study sites.

5. Product labels, brochures, or technical specifications.

6. Copy of ISO 13485 certificate (for manufacturers).

7. Undertaking that the products will not be sold commercially.

8. Authorization letter (if application submitted by agent/consultant).

How to Apply for CDSCO Test License Online (CDSCO SUGAM Portal)

The CDSCO has digitized the process through its SUGAM online portal, making it easier for businesses to apply and track their test license applications.

Step-by-Step Process:

1. Register on the CDSCO SUGAM PortalCreate a valid user ID and profile under the category “Medical Devices Importer/Manufacturer.”

2. Prepare Application DocumentsGather all the documents listed in the checklist in PDF format.

3. Fill out the Online ApplicationSelect Form MD-16 (for import) or Form MD-17 (for manufacture) and upload all relevant documents.

4. Pay the prescribed The payment can be made online through the portal.

5. Application ReviewCDSCO reviews the documents and may seek clarifications or additional data.

6. Grant of Test LicenseOnce approved, you’ll receive the test license digitally through the SUGAM dashboard.

Fees for CDSCO Test License

As per the Medical Device Rules, 2017, the current government fee structure is as follows:

Type of Application	Form	Purpose	Government Fee
Import for Testing	MD-16	To import medical devices for testing, evaluation, or demonstration	₹1,000 per device
Manufacture for Testing	MD-17	To manufacture devices for testing, evaluation, or demonstration	₹500 per device

Validity and Renewal of CDSCO Test License

• Typically, the test license CDSCO is valid for one year from its issue date.

• It can be renewed or reapplied if the testing process extends beyond this period.

• The license remains valid only for the specified quantity and purpose mentioned in the approval.

Final Thought

In the highly regulated medical device environment of India, the CDSCO Test License is an important compliance aspect to demonstrate that your products meet both the safety and performance standards of India before being provided to patients.

By following the steps within the CDSCO test license process, preparing the documentation checklist, and being transparently regulated among both the manufacturer and the importers, you and your organization can expedite the product development and future licensing.