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 Classification	Examples	Risk Level
Class A	Simple surgical instruments, tongue depressor	Low
Class B	Digestive catheters, infusion pumps, and powered wheelchairs	Low-Moderate
Class C	Dialyzers, and orthopaedic implants	High-Moderate
Class D	Coronary stents	High

Premarket Approval Process

Class A	Class B	Class C	Class 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 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

Validity	Four 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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