Medical Device Registration and Approval in Israel

General country-specific regulatory information is provided on this page for medical device registration and approval in Israel. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Israel, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Israel

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

Last updated on January 22, 2018. 

Other Middle East & North Africa Countries:

Algeria, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Tunisia, United Arabic Emirates , Yemen

Submit inquiry


* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.

Request a personal demo of Licensale.com

*Same day demos are not available