Iran Regulatory Requirements

The regulatory requirements for medical devices in Iran are based on the manufacturer’s claim and the field of application of the device. According to the Iranian Medical Devices Administration (IMEDA), medical devices are classified into four categories (A – B – C – D), where A indicates low risk and D indicates high risk. Foreign manufacturers intending to market medical devices in Iran must appoint a local authorized representative responsible for submitting the documents required in the registration process to the Committee on Medical Equipment (COME). The COME will review the application and approve the product if it qualifies. The review process considers the safety and performance of the medical equipment and supplies. The labelling and documentation language must be in Persian.