General country-specific regulatory information is provided on this page for medical device registration and approval in Israel.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Medical devices in Israel are regulated by the Ministry of Health.
CLASSIFICATION SYSTEM: Classes I, II and III
TIMEFRAME: 120 working days starting from the day the Ministry of Health acknowledges letter of license submission
LICENSE VALIDITY: Depends on CE and ISO validity period (the shortest one) and can also be reflected by the ISO validity time of the importer
AUTHORIZED REPRESENTATIVE: Licensed importer
For detailed device-specific compliance information for each market, including Israel, to expedite the preparation of your medical device or IVD registration application.
Did you know you can onboard your medical device or IVD compliance information to our system in less than 15 minutes?
And, in less than a minute, you can start your device-specific registration application and a complete county-specific registration process in this country or any of the other 140+ countries available for you through the Arazy Group Medtech registration platform.
