REGULATORY AUTHORITY: Medical devices in Israel are regulated by the Medical Device Division of the Ministry of Health.
CLASSIFICATION SYSTEM: Risk-Based classification, similar to the US FDA/ EU CE –
Classes I, II and III
TIMEFRAME: 120 working days starting from the day the Ministry of Health acknowledges the letter of license submission. The schedule for processing requests for registration in the fast track is detailed in the registration procedure in the fast track and is between 10 working days and 60 working days, depending on the type of request and the level of risk of the medical equipment.
LICENSE VALIDITY: Depends on CE Certificate or The ISO validity period (the shortest one) and can also be reflected by the ISO validity time of the importer.
AUTHORIZED REPRESENTATIVE: Local License Holder
ADDITIONAL INFORMATION: For non-Israeli manufacturers, AMAR registration is based on having prior approval in one of the following reference markets: Australia,New Zealand, Canada, Europe, or the US.
