MEDICAL DEVICE REGISTRATION AND APPROVAL IN Israel

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 update: December 2022

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

 

Other Middle East & North Africa Countries: Algeria,Bahrain,Egypt,Jordan,Kuwait,Lebanon,Morocco,Oman,Palestine,Qatar,Saudi Arabia,Tunisia,United Arabic Emirates ,Yemen

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