Iran Medical Device Regulations

Agency
All medical devices are regulated by the Ministry of Health and Medical Education - Food & Drug Administration
Medical Device Definition
Equipment and medical supplies is any product, devices, equipment, tools and accessories,machinery, implant, material, reactive, laboratory calibrator, software, intended by the manufacturer to be used (alone or in combination with other items for humans for the following purposes: Diagnosis, monitoring, prevention, or treatment of disease reduction; Continue life support or support; Control and contraception; Create a process sterilization or disinfection and cleaning equipment, environment and medical wastes to desirable carrying out medical, therapeutic and health; Providing information for medical purposes by laboratory methods on Human samples; Diagnosis, monitoring, treatment, relief, compensation or correction of injury or disability replacement or modification of physiological or anatomical processes. - Study, evaluation and replacement or correction of physiology or anatomic process Regulations of equipment and medical supplies, Art. 1.
Classification of Medical Device
International ClassificationExamplesRisk Level
Class ASimple surgical instruments, tongue depressorLow
Class BDigestive catheters, infusion pumps, and powered wheelchairsLow-Moderate
Class CDialyzers, and orthopaedic implantsHigh-Moderate
Class DCoronary stentsHigh
Premarket Approval Process
Class AClass BClass CClass D
Appoint a Local Authorized Representative in Iran that will be responsible for the registration process.
All EAR99 medical devices qualify for the general license unless they appear on the exclusion list.
Prepare a common submission dossier template (CSDT) which includes classification and description of medical device, labeling information, Quality Management Certificate (ISO 13485), and CE approval. CSDT shall be written in English. Label and instructions for use must be provided in Persian. For the application form, click here.
Also Required: Summary of Safety and Effectiveness Studies, Risk Management Report, and Material Specifications.
The Medical Device Board (MDB) will then review dossier and grant registration.
Additional Information
ValidityFour years
Post Market Surveillance Batch release for high risk medical equipment is required.Regulations of equipment and medical supplies. Art. 36
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