Who Must Appoint an IAR?

Every foreign manufacturer seeking a CDSCO import licence (Form MD-14 or MD-15) for notified medical devices must appoint an Indian Authorised Representative (IAR).

The IAR must be named on the SUGAM application and on the issued licence. There is no exemption for foreign manufacturers with a direct India presence, unless they hold an Indian business registration (in which case they may act as their own IAR).

Official source: Medical Devices Rules 2017, Rule 8; CDSCO