Details on Declaration Route for Class I Medical Devices in Israel

By Megan Gottlieb and Evangeline Loh

As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced (August 14, 2023) proposed amendments to the medical device regulatory system.

Significant changes were proposed for the lowest risk classification of medical devices, Class 1. As part of the information brief (link in Hebrew), the Ministry of Health shared that Class 1 represents 40% of Israel's medical device registrations.

These devices would now be able to benefit from immediate registration/self-declaration for medical devices with reference country authorization. The reference countries are defined by Schedule 1 of the Medical Equipment Law explicitly: 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 also accepts Japan and other EU member states, provided there is registration and sales in an EU-recognized country, or a CE Marking Certificate issued to the Medical Devices Regulation (2017/745, MDR).

Declaration route launched for Class I

Rapidly after the Ministry of Health announcement in August, AMAR launched the amended regulatory system for Class I medical devices (September 3, 2023). This is referred to as the declaration route, which is now part of the registration portal. At the same time, AMAR released accompanying guidance (link in Hebrew).

The guidance defines the low-risk Class I devices from the European legislation perspective as:

• Medical Devices Regulation (MDR 2017/745) Class I (including Class I reusable surgical instruments, Class I measuring, Class I sterile)
• In Vitro Diagnostics Devices Directive (IVDD 98/79/EC) self-certified and
• In Vitro Diagnostics Devices Regulation (IVDR 2017/746) Class A

Instructions related to the submission for new registrations for Class I

Both the application (request form template from the Ministry of Health website (PDF)) and the associated evidence (ZIP file (five folders)) are to be submitted.

The guidance describes how to complete the PDF as well as the documents to be provided in the folders/ZIP file.

The structure and documents in the ZIP file are as follows:

*The numbering reflects the format required. There are folder numbers missing because this information is not required.

Renewals and changes are also managed as declarations through the system for Class I

The following must be submitted for yearly renewals: application (renewal form template from website (PDF)), annual declaration (October-October), and current reference country authorizations.

The information submitted for a change application for a Class I medical device would be identical to a new Class I medical device registration.

Concluding remarks

There are explicit directions for how to name the PDF and ZIP included in the guidance. Failure to follow the directions will result in a rejection of the application. Within four hours, the submitter will receive an email of receipt of the documents, provided the instructions were followed. Within 48 hours, the registration confirmation in the Ministry of Health registration database will be sent to the submitter.

AMAR continues to charge no fees for Class I device new, renewal and change applications.

Emergo by UL will continue to monitor developments in Israel and publish updates as they develop.

Megan Gottlieb is Senior Program Service Specialist, Regulatory Services and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.