Israel Market Access for Medical Device

REGULATORY AGENCY

• Israel’s Ministry of Health (IMOH)

REGULATIONS

• All medical devices, including biologics, must be registered with IMOH.
• IMOH recognises US FDA certification and the EU CE Mark, and usually approves products carrying such certifications without further requirements.
• Importers also require a pre-marketing approval from IMOH, for which US FDA 510(K) or PMA, CE Mark, or Canadian documentation is required.

GUIDELINES

• A local representative is required.
• For imported devices, application for registration should include, if available, a certificate issued by a competent authority from one of the following countries - Australia, Canada, EU, Japan, or USA.
• If such a certificate is not available, the registration process is still available but will take a longer time. MOH will also determine what type of testing is required.
• Apart from appropriate safety certification, other essential documentation and DoC should be submitted to IMOH.

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