Test License for Medical Devices to Import – Checklist And Necessary Documents

Test License for Medical Devices to Import

An importer or manufacturer who wishes to import Class A, Class B, Class C, or Class D medical devices to India can apply for a test license. The Central Drugs Standard Control Organization (CDSCO) issues medical device import licenses.

The test license for Medical Devices can be obtained via form MD17. Importers or manufacturers can use this test license for the purpose of testing, evaluation, training, or demonstration of medical devices.

The applicant can apply to the CDSCO via form MD16. This application should be made on an online portal, Sugam, where the applicant must also pay the fees and upload documents.

Forms required for test license to import medical devices

• Form MD 16:The applicant can apply for the test license to import medical devices via form MD16. The purpose of import should be testing, evaluation, training, or conducting clinical trials.
• Form MD 17: The CDSCO grants permission to import medical devices via form MD 17. The importer of the manufacturer can then import medical devices for the purpose of testing, evaluation, training, or conducting clinical trials.

Eligibility and the process of application:

An importer or manufacturer who imports products in India can apply for a test license to import medical devices. The applicant can apply to the regulatory body via Form MD 16 on an online portal called Sugam.

The process of application for a test license of the medical device is as follows:

• Online registration on the Sugam portal
• Drafting of the online application
• Uploading of documents as mentioned in the form MD 16
• Processing of the fee required by the regulatory body
• Submission of application via an online portal

The importer or manufacturer must pay fees to obtain a license for importing medical devices for testing, evaluation, training, or demonstration. The applicant is required to pay 100 US dollars per medical device.

Essential documents for the application process

During the application process, the applicant must submit a description of the medical device, including the material of construction, design label, intended use, and instructions for use must be submitted. 

A checklist and necessary documents to get a test license for the import of medical devices are given in the table below:

Essentials

The importer or manufacturer who wishes to obtain permission to import medical devices must ensure the following:

• The quantity of medical devices the applicant wishes to import must be specified during the online application process
• The batch details, amount to be retained, and quantity to be utilized of the medical devices must be specified during the online application process
• If the medical devices are to be imported for the purpose of clinical investigation, then the applicant needs to specify the protocol of the clinical trials
• The name of the location where the applicant will conduct testing, evaluation, training, or demonstration must be specified during the online application process

Validity of the License

The license is obtained under form MD 17 from the CDSCO within 30 working days of the government. After obtaining the license in Form MD 17, the test licence is valid for three years.

After getting the test license for the import of medical devices, the importer or manufacturer should maintain the following records:

• The date and quantity of medical devices which were imported
• The manufacturer’s name
• A statement or invoice that contains the details such as the name and quantity of medical device that was imported

In addition to maintaining the essential records, the test license holder must also ensure that the medical device is only being used for the purpose it was imported.

Summary

• To obtain a test license for importing Class A, Class B, Class C, or Class D medical devices in India, an individual can apply via form MD 16
• The CDSCO grants test licenses via Form MD 17
• The test license can be used for testing, evaluation, training, or demonstration of medical devices
• Documents containing a description of the medical device, including the material of construction, design label, intended use, and instructions for use, must be submitted during the application process

References:

1. Permission To Import Medical Devices Test License | Test License to Import Medical Device [Internet]. CliniExperts. 2022 [cited 9 August 2022]. Available from: https://cliniexperts.com/india-regulatory-services/medical-device/for-importers/permission-to-import-medical-devices-test-license-india-form-md-16-md-17/. 
2. MD – Medical Devices [Internet]. Cdscomdonline.gov.in. 2022 [cited 9 August 2022]. Available from: https://cdscomdonline.gov.in/NewMedDev/viewChecklistReport.