Regulatory Authority

Central Office for Medical Equipment (COME)


A, B, C, D

Quality system

ISO 13485:2016

Medical Devices are subject to registration.
Foreign manufacturers intending to market Medical Devices in Iran must appoint a Local Authorized Representative responsible for the submitting the documents required in the registration process to the COME.


Local Authorized Representative.

Labelling and documentation language

Documentation and labelling must be provided in Persian.

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