August 23, 2023
By Megan Gottlieb and Evangeline Loh
The Medical Device Division, AMAR, of the Ministry of Health in Israel has announced proposed amendments to the medical device regulatory system (August 14, 2023). The changes are intended to reduce the registration and import timelines, decrease the regulatory burden, and potentially increase the number of devices available in Israel.
Israel's medical device regulation background
Israel’s regulatory system is based on two legislations: the Medical Equipment Law, May 8, 2012, and the Regulations for Medical Equipment Registration.
Background on recognized countries
Registration of medical devices in Israel involves leveraging authorization from the regulatory system of a recognized country. Schedule 1 of the Medical Equipment Law explicitly defines these as: Austria, Australia, Italy, Iceland, Ireland, United States, Belgium, United Kingdom, Germany, Denmark, the Netherlands, Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden and Switzerland.
In practice, AMAR accepts Japan and other EU member states, as well, provided there is registration and sales in an EU-recognized country. In addition, regardless of the origin of the EU Notified Body, all CE Marking Certificates issued by Notified Bodies designated to the Medical Devices Regulation (2017/745, MDR) are accepted.
Background on risk classification
A risk classification system is not delineated in the Medical Equipment Law and Regulations for Medical Equipment Registration. Rather, the device in Israel adopts the risk classification of the device in the recognized country for the purpose of registration in Israel.
Proposed changes to registration routes
Changes have been proposed for Class 1 and Class 2 devices. The registration system for Class 3 devices remains intact.
Class 1 devices will benefit from immediate registration/self-declaration.
While declarations and technical documents will still be required for Class 2 devices, AMAR will create a list of devices they consider to be of low-medium risk, which may benefit from a reduced processing time of 14 days if the manufacturer possesses two authorizations from two recognized countries, plus six months of market data from the two recognized countries. Alternatively, if a manufacturer of a Class 2 device only has a US FDA 510(k) clearance, plus six months of market data from the US, the AMAR processing time will be 60 days (accelerated).
Preference for the US (FDA) as one of the recognized countries
From Emergo’s experience, AMAR prefers leveraging the US FDA authorization. This is supported by the additional information for the Class 2 devices. When two markets are leveraged, there is a statement (unofficial translation) “in case of double registration the validity will be determined according to the FDA validity". And one of the proposed accelerated routes is specific to FDA authorization devices.
Proposed changes to renewals and modifications
Changes are also proposed to the renewal system, as well as modifications, to decrease the AMAR processing times.
For Class 1 devices, an annual declaration of the validity of the data submitted for registration will be a condition for continued importation.
For registrations based on the US FDA 510(k) without any defined validity period, the registration will also be issued with no limits, as long as the registration with the FDA is still valid.
Decreasing AMAR review times
The amendments proposed represent a significant decrease in AMAR review times, with recognized country authorization. Class 1 devices would be immediately registered. Class 2 devices with two recognized countries and market data would be processed in 15 days, and with a US FDA 510(k) clearance and market data, reviewed within 60 days. There are also proposals to decrease the AMAR renewal process.
Additional guidance is expected. As an example, one would expect that unless a manufacturer had a UKCA Marking from a UK Approved Body, leveraging the CE Marking in the EU and UK would not constitute two recognized countries.
Megan Gottlieb is Senior Program Service Specialist, Regulatory Services and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.
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