Indian Medical Device Rule 2017: Understanding MD-16 and MD-17
- Sunita Bhargava
- Nov 6, 2025
- 3 min read
Updated: Dec 2, 2025
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:
Email: info@bharrgava.com
Phone: +91 8802904502
Start with the import license for testing purposes, as it ensures all medical devices are legally and safely brought in for evaluation. This process is crucial for compliance, accuracy, and patient safety before any commercial use or market approval Kindle Direct Publishing help
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