🇮🇱Israel Medical Device Regulations

Registration Procedure - Documents Required for Registration

Official procedure document (REG-2024/03) detailing the documents required for registration in the medical equipment register. Includes requirements for special rooms, training, qualifications, and warnings.

Medical Equipment Import Requirements

Guide for importing medical equipment to Israel. Import through customs requires Ministry of Health approval per the Free Import Order. Details products requiring import license or compliance verification.

Medical Equipment Division Guidelines Collection

Collection of official guidelines from the Medical Equipment Division including registration procedures, classification requirements, and compliance documentation.

Medical Equipment Division Forms

Official forms for medical device registration, import permits, and other AMAR services. Includes application forms for device registration and renewal.

About the Medical Equipment Division

Overview of the Medical Equipment Division responsibilities including device registration, import/export permits, and market supervision. Israel accepts CE and FDA certified products via reference country pathway.

Medical Device Division - Ministry of Health

The Medical Device Division (AMAR) handles registration, import permits, marketing supervision, and export documentation for medical devices in Israel. Established in 1993 under the Medical Equipment Law of 2012.