![iran-300×159 iran](http://www.thema-med.com/wp-content/uploads/2022/12/iran-300x159-1.png)
Regulatory Authority
Central Office for Medical Equipment (COME)
Classification
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.
Applicant
Local Authorized Representative.
Labelling and documentation language
Documentation and labelling must be provided in Persian.