Import Registration Overview
What is required to import a medical device into India?
All medical devices notified under Schedule I or Schedule II of the Medical Devices Rules 2017 require a valid import licence or registration before they can be imported and sold in India.
There are two pathways:
| Pathway | Applicable to | Form |
|---|---|---|
| Full import licence | Class B, C, and D devices | Form MD-14 |
| Registration / self-declaration | Class A devices | Form MD-15 |
Both applications are submitted through the SUGAM portal (sugam.cdsco.gov.in).
Who applies?
The application is made by the Indian Authorised Representative (IAR) on behalf of the foreign manufacturer, or directly by the manufacturer if they have a business presence in India. The IAR's name and details must appear on the licence.
General document requirements
For Form MD-14 (Class B/C/D):
- Application form via SUGAM;
- Free Sale Certificate (FSC) from the competent authority of the country of manufacture;
- Certificate of Conformity (CoC) or equivalent third-party certification;
- Technical documentation (STED format);
- Performance/safety test reports from CDSCO-notified or accredited labs;
- Clinical data (for Class C/D or new devices);
- Labelling specimens;
- IAR appointment letter;
- Applicable fees.
New devices vs already-approved devices
A simplified pathway exists for devices that are already approved by a major reference regulatory authority (US FDA, EU CE, TGA, Health Canada, or PMDA Japan). Such devices may be eligible for expedited review and reduced clinical data requirements. See New Device vs Already-Approved Device Routes.