Registration in Isreael

To access the Israeli market, medical devices must be registered with the Israeli Ministry of Health (AMAR) under the Medical Devices legislation.

Registration is based on the device already being registered in one of the Global Harmonization Task Force (GHTF) countries: Australia, Canada, Europe, Japan, or the USA.

The process requires documentation proving compliance with the standards and regulations of the GHTF country where the device is registered.

Registration must be conducted through an Israel Registration Holder (IRH), based in Israel, and all documentation must be submitted in Hebrew.

For all these markets, Maytal experts, together with local partners, can:

• Prepare the necessary documents for the Medical Device Dossier to submit to the local Competent Authority

• Manage interactions with the Authority during the review process

• Provide local representation services (Local Agent) for foreign manufacturers

• Manage license renewals to ensure continuous market access