Who Must Appoint an IAR?

All foreign manufacturers seeking a CDSCO import licence (Form MD-14 or MD-15) for notified medical devices must appoint an Indian Authorised Representative (IAR), except where specifically exempted by regulation.

The IAR must be named on the SUGAM application and on the issued licence. Foreign manufacturers with a direct India presence and valid Indian business registration may act as their own IAR; others must appoint an external Indian Authorised Representative.

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