Israel MOH Regulatory News

Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.

Regulatory Framework

Regulatory Authority: Ministry of Health (MOH), Division of Medical Devices and Accessories (AMAR)

Key Legislation:

• Pharmacists Ordinance [New Version] 1981
• Medical Devices Order (Control and Supervision of Medical Devices) 2014
• Standards Institution of Israel Law

Classification: Israel recognizes CE-marked devices (EU MDR) and FDA-cleared/approved devices. No independent Israeli classification system -- relies on classifications from recognized reference authorities.

Registration Pathway:

1. Appoint a local Authorized Representative in Israel
2. Submit Import License application to AMAR
3. Reference authority route: devices with CE marking (EU) or FDA clearance/approval receive expedited review
4. Non-reference authority route: full dossier review
5. Manufacturing site GMP compliance verification

Key Requirements:

• Import License from AMAR required before marketing
• Local Authorized Representative mandatory for foreign manufacturers
• Recognition of CE marking (EU MDR) and FDA clearance/approval
• Hebrew-language labeling required for retail products
• Periodic renewal of Import License
• Post-market surveillance and adverse event reporting (AMAR)
• Mutual Recognition: Israel-EU MRA covers medical devices

Current Key Guidance:

• AMAR Registration Guidelines (MedDeviceGuide)
• AMAR Class I Declaration Route (MOH PDF)
• AMAR Registration Guide (MedDeviceGuide)
• Standards Institution of Israel

Latest Updates

No recent updates available. Please check back later.