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What are the Responsibilities of an Indian Authorized Agent for Medical Devices Import?

Updated: Jun 20, 2023

indian authorized agent for medical device import cdsco

Responsibilities of an Indian Authorized Agent for Medical Devices Import

An Indian Authorized Agent must fulfill the following responsibilities detailed in the Medical Device Rules (MDR), 2017 to be able to import medical devices:

1. Submit the import license application

2. Liaise with the CDSCO in case of any additional information request until approval

3. Submission of Test License for import, for the test, evaluation, and clinical investigations

4. Post-approval changes and endorsement applications

5. Post-marketing surveillance activities

6. Notify any adverse reaction, recalls, and Regulatory restrictions within fifteen (15) days

7. Obtain prior approval before implementation of any major changes

8. Notify minor changes within a period of thirty (30) days

9. Inform any change in the constitution of the manufacturer or the IAA within thirty (30) days

Criteria for becoming an Indian Authorized Agent / Representative

1. Foreign manufacturers may appoint importers or distributors as their IAA.

2. To act as a foreign manufacturer’s IAA, the following are the prerequisites,

3. Be any corporation or enterprise established in India with an active Corporate Identification Number (CIN).

4. Be a Resident of India.

5. Obtain Power of Attorney (POA) from the foreign manufacturer for medical device registration with the CDSCO.

6. Have a Manufacturing or Wholesale or Distributor License (MD40,41,42).

7. SUGAM account registration

The regulatory reforms by CDSCO for governing medical device manufacturing, import and sale in India has added more responsibilities on Indian Authorized Agent to ensure quality and safety of medical device in India.


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