Updates on Israel’s Declaration and Fast-Track Routes for Medical Devices

By Adriel Robles and Megan Gottlieb

As reported by Emergo by UL (August 2023), the Ministry of Health of Israel issued several reforms (link in Hebrew) to streamline the registration process for medical devices and IVDs. As a result of these reforms, there are now three registration routes in Israel: Declaration Route, Fast-Track Route, and Normal Route. The Fast-Track Route has recently been launched, and the Ministry of Health has published a number of new guidelines. Further details about each route are provided below.

Declaration route

As reported in January, all low-risk (Class I or Class A) devices must now register through the Declaration Route: immediate registration/self-declaration based on reference country authorization.

Emergo by UL has reported additional details on the Declaration Route in our September Regulatory Update when the route was first launched. There are explicit directions for how to prepare the Declaration Route submission in the AMAR guidance (link in Hebrew).

Fast-Track route

As of June 2, the Fast-Track Route is available for new registrations of some medium-risk devices. AMAR published the guideline REG-2024/06 Instructions for Registration in the Medical Device Register on a Fast-Track, which defines two paths, depending upon risk classification:

• Fast 1: Class II (US FDA) and Class IIa (EU) devices, as well as Class B (EU IVDR) or Self-Test (EU IVDD) IVDs, that have market authorization in a reference country and have been marketed in that country for at least 4 months.
• Fast 2: EU Class IIb devices, as well as Class C (EU IVDR) and List B (EU IVDD) IVDs, that have market authorization in two independent reference countries and have been marketed in one of the reference countries for at least 6 months.

The official review timeframe is 45 business days for Fast 1 and 60 business days for Fast 2.

The Fast-Track Route is also available for renewals and modifications, as described in REG-2024/06. Emergo will share additional information on this in a subsequent post.

Registration applications must be submitted following the conditions outlined in REG-2024/06. For example, an affidavit and a marketing data declaration on AMAR’s template forms must be included.

Normal route

All other devices (i.e., all other Class II devices that do not qualify for the Fast-Track route, Class III devices, and Class D IVDs) are registered via the Normal Route. The process for registration via the Normal Route is largely unaffected by the reforms. Though there is a new guideline on the registration process, REG-2024/03 Registration Procedure in the Medical Device Register – Details of the Documents Required for Registration in the Register, which takes effect January 1, 2025.

The official review timeframe for the Normal Route is 120 calendar days from submission. In practice, however, a submission will generally take about 4.5–6 months for final approval from AMAR.

Concluding remarks

The Ministry of Health of Israel remains committed to facilitating the registration process for medical devices and IVDs. Fast 1 and Fast 2 are intended to be a more efficient process for medium-risk devices with previous reference country authorization(s).

Emergo by UL can provide Israel Registration Holder services through our local office in Israel, and will submit the registration documents to AMAR, hold the device approval, and act as a liaison with the regulators at AMAR.