Skip to main content

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.

IAR liability and insurance: The IAR is the legally liable entity for post-market performance, adverse event reporting, and regulatory compliance in India. CDSCO may take enforcement action (warning letter, suspension, or cancellation of the licence) against the IAR if regulatory conditions are breached or the device is found to be non-compliant. The IAR should maintain product liability insurance and product recall insurance. The foreign manufacturer should provide a written indemnification/hold-harmless agreement to protect the IAR from liability for manufacturing defects or approval in the home country.