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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.
Last updated on November 22nd, 2021.
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
For detailed device-specific compliance information for each market, including Israel, to expedite the preparation of your medical device or IVD registration application.
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