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Key Roles and Responsibilities

Indian manufacturers​

An Indian manufacturer holds a manufacturing licence granted by CDSCO (Class C/D) or the State Licensing Authority (Class A/B). Key responsibilities:

  • Maintain GMP in accordance with Schedule 5 of MDR 2017;
  • Label devices in accordance with Schedule 3;
  • Report adverse events and field safety corrective actions to CDSCO;
  • Maintain technical documentation and quality records.

Foreign manufacturers​

A foreign manufacturer whose devices are imported into India must:

  • Hold an import licence (Form MD-14) granted by CDSCO, or register Class A devices (Form MD-15);
  • Appoint an Indian Authorised Representative (IAR);
  • Provide a Free Sale Certificate from the country of manufacture;
  • Ensure GMP compliance recognised by CDSCO.

Indian Authorised Representative (IAR)​

The IAR is the entity in India legally responsible for import compliance on behalf of a foreign manufacturer. The IAR must:

  • Be named on the CDSCO import licence;
  • Act as the primary contact for CDSCO on regulatory matters;
  • Manage vigilance reporting and recall coordination in India;
  • Maintain copies of technical documentation.

See IAR Obligations for full details.

Importers​

An importer brings foreign-manufactured devices into India under a valid CDSCO import licence. The importer may be the IAR, or may be a separate entity acting under the IAR's licence.

Distributors and stockists​

Distributors and stockists operate under wholesale dealer licences granted by State Licensing Authorities. They must maintain storage conditions appropriate to the device and support recall activities.

Notified testing laboratories​

India has a network of CDSCO-notified testing laboratories that conduct performance and safety testing for import licence applications. See Notified Labs Directory for the current list.