Streamlined Registration of Medical Devices

The IL MOH recently published a draft amendment to the Medical Device Regulations aiming to streamline the registration process of medical devices and IVDs and reduce regulatory burden.

The current process of registering medical devices in Israel does not sufficiently differentiate between various risk levels of medical devices. Accordingly, all devices must meet the same uniform regulatory requirements, even if they are low-risk products. The proposed amendment reflects a flexible registration model which allows expedited registration of low-risk products which were approved in Recognized Countries (US, EU-15 states including the UK, Australia, New Zealand, Iceland, Norway, Canada and Switzerland). The new registration model is briefly summarized below:

● Low-risk devices (Class I): registration via notification pathway – immediate registration based on a declaration that the device is approved in a Recognized Country.

● Medium-risk devices (class II/IIa) – fast-track registration within 45 business days based on prior approval in a Recognized Country.

● Medium to high-risk devices (Class IIb) – fast-track registration within 60 business days based on prior approval in a Recognized Country.

● High-risk devices (class III) – full evaluation by the IL MOH.

The proposed amendment is expected to shorten the time-to-market for Class I-II devices in Israel, reduce regulatory costs and better align Israeli regulatory regime with international standards. Once the proposed amendment enters into force, the classification of the medical device will become critical as it will determine the registration route and timelines.

This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.