Import Registration Overview
Overview of the import licensing process for medical devices in India under the Medical Devices Rules 2017.
Form MD-14 — Import Licence (Class B / C / D)
Detailed guide to obtaining an import licence (Form MD-14) for Class B, C, and D medical devices in India via CDSCO and the SUGAM portal.
Free Sale Certificate (FSC)
Requirements and formats for the Free Sale Certificate (FSC) needed for medical device import licence applications in India.
Certificate of Conformity (CoC)
The Certificate of Conformity requirement for medical device import licence applications in India and accepted international standards.
Indian Authorised Representative (IAR)
The role, obligations, and appointment process for the Indian Authorised Representative (IAR) for foreign medical device manufacturers.
SUGAM Portal — Submission Process
Step-by-step guide to submitting a medical device import licence application on the CDSCO SUGAM portal.
CDSCO Review Timelines & Fees
Indicative review timelines and fee structure for medical device import licence applications in India.
New Device vs Already-Approved Device Routes
The difference between the new device route and the already-approved (reference authority) route for medical device import licences in India.
Class A Import — Form MD-15 Self-Declaration
The streamlined Class A import registration process using Form MD-15 in India.