Appointing Changing
See Indian Authorised Representative (IAR) for full details on IAR obligations and the appointment and change process.
Official source: Medical Devices Rules 2017, Rule 8 and Rule 16
Add procedural content such as: 'To appoint an Indian Authorised Representative (IAR): 1. Select a suitable entity registered in India with relevant expertise. 2. Obtain a Power of Attorney document signed by authorized personnel at the foreign manufacturer. 3. Submit a formal application through SUGAM portal with [required documents]. 4. To change an IAR: File a request detailing the current and new IAR with supporting authorization documents. The change becomes effective upon CDSCO approval.' Include timelines and required supporting documentation.