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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.

State Licensing Authority (SLA)

State Licensing Authorities grant manufacturing licences to Class A and Class B device manufacturers at the state level. They also license wholesale dealers and retail sellers. Manufacturers must comply with state-level GMP inspections and maintain records as required by the SLA.