Indian Medical Device Rule 2017: Understanding MD-16 and MD-17

Nov 6, 2025
3 min read

Overview of Medical Device Import Regulations

An importer or manufacturer looking to bring Class A, Class B, Class C, or Class D medical devices into India can apply for a test license. The Central Drugs Standard Control Organization (CDSCO) is responsible for issuing import licenses for medical devices.

The test license for medical devices can be acquired through form MD17. This license allows importers or manufacturers to test, evaluate, train, or demonstrate medical devices.

Applicants can submit their application to the CDSCO using form MD16. This process is conducted on the online portals Sugam or NSWS. Here, applicants must also pay the required fees and upload necessary documents.

Forms Required for Test License to Import Medical Devices

Form MD 16

Applicants can apply for a test license to import medical devices using form MD16. The import should serve purposes such as testing, evaluation, training, or conducting clinical trials.

Form MD 17

The CDSCO authorizes the import of medical devices through form MD 17. Importers or manufacturers can then bring in medical devices for testing, evaluation, training, or clinical trials.

Importers or manufacturers must pay fees to secure a license for importing medical devices for testing, evaluation, training, or demonstration. The fee is 100 US dollars per medical device.

Essential Documents for the Application Process

During the application process, applicants must provide a description of the medical device. This description should detail the material of construction, design label, intended use, and instructions for use.

A checklist and the necessary documents to obtain a test license for importing medical devices are provided in the table below.

S. No.	Document	Remark
1	Covering Letter	Mandatory
2	Description of the medical device,such as the intended use, the material of construction, and design	Mandatory
3	Justification of quantity proposed to be imported	Mandatory
4	Test protocol or approved clinical investigation plan, if any	Optional
5	Quality certificates of the manufacturer (E.g., the quality management system), if any	Optional
6	Instructions for use and labels, if any	Optional
7	Other documents, if any	Optional
8	An undertaking which states that the medical devices will be imported exclusively for the purpose specified in Form MD 16 and will not be used for commercial purposes	Mandatory
9	An undertaking from the testing laboratory states that the laboratory will provide necessary facilities such as the instrument, equipment, and personnel to test or evaluate the medical device	Mandatory
10	Fee challan	Mandatory
11	Legal form	Mandatory

Essentials for Importing Medical Devices

Importers or manufacturers seeking permission to import medical devices must ensure the following:

The quantity of medical devices intended for import must be specified during the online application process.
During the online application process, the batch details, the amount to be retained, and the quantity to be utilized of the medical devices must be specified.
If the medical devices are intended for clinical investigation, the applicant must specify the clinical trial protocol.
The location where testing, evaluation, training, or demonstration will occur must be specified during the online application process.

Validity of the License

The license is issued under Form MD 17 by the CDSCO within 30 working days. Once obtained, the test license in Form MD 17 is valid for three years.

After acquiring the test license for importing medical devices, the importer or manufacturer must maintain the following records:

The date and quantity of imported medical devices.
The manufacturer's name.
An invoice or statement detailing the name and quantity of the imported medical devices.

Besides maintaining these essential records, the test license holder must also ensure that the medical device is used solely for its intended import purpose.

For further information and updates, please contact us at: