The Israeli Ministry of Health (the “MOH”) recently published a framework of a reform in the registration procedure of medical devices (the “Reform”), implementing different classification for medical devices, and different procedures for receiving marketing approvals for the various classes of medical devices.
The Reform establishes (a) an immediate and declarative route for registration of medical devices, that fall within “class I” (in line with European classification); (b) an immediate and declarative route for registration of low to medium risk medical devices, that fall within “class II”; (c) an expedited route for registration of medical devices that fall within “class II” and that are registered with the FDA (we note that the intent is to relate to devices that have valid marketing approvals) and have already been distributed in the US for at least six months; and (d) a new registration renewal procedure for devices that are already registered with the MOH’s medical devices department (also known as “AMAR”). “Class III” shall remain without any change in the registration route, subject to certain changes introduced by the Reform.
The first phase of the Reform, which entered into effect on September 3, 2023, was the implementation of a shortened route for registration of “class I” medical devices (including low-risk IVD laboratory equipment, Class Ir, Class Im, Class Is) (“Class I Route”). Class I Route medical devices can, under the Reform, be registered in the medical devices register maintained by the MOH (the “Register”) with immediate effect, based solely on a declaration of the intended registered holder. The respective application for registration will be submitted on AMAR’s online portal and shall include details of the relevant device and certain requested declarations, including a declaration as to the device and its compliance with quality standards. An application may be declined unless submitted according to the instructions published by the MOH. Maintenance and renewal of registration for class I medical devices will be based on declarations and will be further subject to several conditions. Medical devices that are already registered with AMAR, and fall within “Class I”, may be transferred to the declaration route by submission of a registration renewal or modification application.
This part of the Reform is currently in effect. The MOH informed that, by October 1, 2023, it will compile a list of medical devices that fall within “class II” classification, at low-medium risk level, that will be registered in the Register based on declaration only. Additional information regarding “class II” medical devices registration will be published by the MOH.
In addition, the Reform includes the following rules and principles regarding the validity of registration and marketing of medical devices: (i) the validity of medical device registration in Israel is based on the registration status in the country of reliance (EU (CE)/US (FDA)). If a medical device is registered in both the EU and US, the FDA registration will prevail; (ii) if a registration has a specified validity period, the MOH’s registration validity period would match it; (iii) if there is no specified validity period for a medical device registered with the FDA, a registration without period limitation will be issued by the MOH, subject to the device remaining the same as registered with the FDA; (iv) the duration of marketing approval in Israel would match that of the applicable country of reliance; and (v) the validity of administrative extensions for medical devices under the MDR will align with the administrative extension in effect in the EU.
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