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.
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