Israel Registration Update: Modifications and Renewals

By Adriel Robles and Megan Gottlieb

New Information about Registration Modifications and Renewals in Israel

As reported by Emergo by UL, the Ministry of Health of Israel is implementing reforms to the registration process for medical devices and IVDs. Our first regulatory update described the three registration routes in Israel: Declaration Route, Fast-Track Route, and Normal Route. The second in the series presents details about the changes to modifications and renewals under this regulatory reform.  

Registration Validity and Renewals

For the lowest risk Class I or Class A devices subject to the Declaration Route, yearly renewals are required. The renewal period runs from October 1^st to the end of each calendar year. Registrations obtained prior to October 1^st will be subject to renewal in the same year.

Registrations obtained via the Fast-Track or Normal Route can be valid for a maximum of 5 years (or only 3 years for implants). If the leveraged reference country authorization has an explicit expiration date, the approval in Israel cannot exceed the validity in the reference country. All renewal applications must be submitted within 4 months prior to expiration. It is advisable to submit the application as early as possible, to best avoid a gap in market access.

AMAR also published the guideline REG-2024/07 Procedure for Renewal of Registration in the Medical Device Register, which provides details on the renewal process. Although it has an effective date of January 1, 2025, AMAR has already referenced this guideline when discussing renewal applications due in 2024, and the related forms are available on the Ministry of Health website. Notably, renewals may be combined with a modification application, so long as the changes are minor or administrative.

Devices that meet the qualifications in REG-2024/06, even if not originally registered under the Fast-Track Route, are eligible for renewal via the Fast-Track Route. For the Fast 2 path, an up-to-date periodic marketing surveillance report is required in the renewal application. For the Fast 1 path, only a declaration that an up-to-date periodic marketing surveillance report is available must be submitted.

What about Pending Renewal Applications under the Normal Route?

For pending renewal applications of devices that meet the Fast-Track qualifications, an updated renewal application may be submitted under the Fast-Track Route, along with updated regulatory documents. For the Fast 1 path, AMAR’s review time is reduced to only 10 business days, while for the Fast 2 path, the review time is 60 business days.

Registration Modifications

Changes to Class I or Class A devices must be made through the Declaration Route in a manner similar to a new registration submission, with a declaration form for the change in registration and documents relevant only to the change.

For devices that qualify for the Fast-Track Route, guidance is available in REG-2024/06. Modifications submitted via the Fast-Track Route will be processed within the following timeframes:

• Fast 1: within 45 business days for a major change and 10 business days for a minor or administrative change
• Fast 2: within 60 business days for a major change and 10 business days for a minor or administrative change

Additionally, minor or administrative changes for Class III devices can be submitted under the Fast-Track Route, and AMAR’s review time is within 10 business days.

Guidance on Registration Modifications

AMAR also published the guideline REG-2024/08 Procedure for Changing Registration in the Medical Device Register, effective January 1, 2025. This provides guidance on the types of changes that are considered major versus minor or require a new registration.

A new registration will be required in the following cases:

• Changing the designation of the device, for example from professional use to home use.
• An increase in the risk classification of the registered device (with the exception of a risk classification change as a result of transitioning to the EU MDR/IVDR).
• For combination devices, a change in the medicinal substance.
• Addition of a new component to a device system (i.e., not a model or accessory).

Concluding Remarks

AMAR has published three guidance documents that provide information about registration renewals and modifications: REG-2024/06 (Fast-Track), REG-2024/07 (Renewal), and REG-2024/08 (Modifications).

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