January 8, 2024
By Adriel Robles and Evangeline Loh
Regulators in Israel have revised registration and approval requirements for some low-risk medical devices and in vitro diagnostic (IVD) products.
In August 2023, the Ministry of Health in Israel, Medical Device Division, AMAR, announced proposed amendments to the medical device regulatory system. Of note, Class I medical devices with reference country authorization would benefit from immediate registration/self-declaration.
The reference countries are explicitly defined by Schedule 1 of the Medical Equipment Law: Austria, Australia, Italy, Iceland, Ireland, the US, Belgium, the UK, Germany, Denmark, the Netherlands, Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden and Switzerland. In practice, AMAR also accepts Japan as well as other EU member states, provided there is registration and sales in an EU-recognized country or a CE Marking Certificate issued to the EU Medical Devices Regulation (2017/745, MDR).
In September 2023, the system for these devices was launched as well as accompanying guidelines titled Guidelines for Registration of Class I Medical Devices or Low-Risk IVD Laboratory Devices under the Declaration Route.
Declaration Route is immediately applicable
AMAR announced on the last day of 2023 that effective 1 January 2024, Class I devices can only be registered through the Declaration Route.
AMAR included a reminder that Class I devices included the following low-risk devices (medical devices and IVDs): Class I, Class I self-certified, Class I sterile, Class I measuring, Class I reusable surgical instruments and Class A.
Class I device applications already submitted for review must be transferred by the Israel Registration Holder or importer to this declaration route.
There are explicit directions for how to prepare for the Class I Declaration route submission in the guidelines.
As a reminder, AMAR committed to an email of receipt of the documents for a complete Class I Declaration route application (within four hours). With 48 hours, the confirmation of registration in the Ministry of Health registration database will be sent.
Emergo by UL will continue to monitor developments in Israel.
Adriel Robles is Regulatory Monitor and Evangeline Loh is Senior Manager, Quality & Regulatory Affairs Program at Emergo by UL.
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