Regulatory Authority
Central Office for Medical Equipment (COME)
Classification
A, B, C, D
Quality system
ISO 13485:2016
The information on this page is valid and current as of February 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
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.
Applicant
Local Authorized Representative.
Labelling and documentation language
Documentation and labelling must be provided in Persian.
