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Indian Authorised Representative (IAR)

What is an IAR?​

The Indian Authorised Representative (IAR) is an entity registered in India that is legally responsible for import licence compliance on behalf of a foreign manufacturer. Every import licence (Form MD-14) must name a valid IAR.

Who can be an IAR?​

The IAR must be:

  • A company or individual registered in India;
  • Named in a formal IAR appointment letter signed by the foreign manufacturer;
  • Registered on the SUGAM portal with the relevant CDSCO zone.

The IAR can be a dedicated regulatory affairs company, an Indian subsidiary of the foreign manufacturer, or an independent distributor/importer — provided they accept the regulatory obligations.

IAR obligations​

By accepting appointment as IAR, the entity accepts responsibility for:

  1. Submitting and maintaining the import licence on SUGAM;
  2. Acting as CDSCO's primary contact for all regulatory correspondence;
  3. Coordinating vigilance reporting (adverse event reports, PSURs) in India;
  4. Managing recalls and field safety corrective actions;
  5. Maintaining copies of technical documentation;
  6. Notifying CDSCO of changes to the device, manufacturer, or IAR.

Changing the IAR​

If the foreign manufacturer wishes to change its IAR:

  1. New IAR submits an amendment application via SUGAM;
  2. Old IAR responsibilities continue until the amendment is approved;
  3. CDSCO issues an amended Form MD-14 naming the new IAR.

See Appointing & Changing an IAR for step-by-step guidance.