Israel Medical Devices Registration

Israel Medical Devices Registration – Part I 

From January 2024 (See here), it is possible to register a low risk class I (class I, Is, Im, Ir) medical devices in the Israel medical devices register, via declaration route. This process must be performed by the Israel Registration Holder (IRH) or an importer.

The low risk class also includes a low risk IVD laboratory equipment such as the class A per the IVDR regulation.

This registration option in Israel only applies to the medical equipment registered and marketed in recognized countries. The registered countries include: 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 addition, all CE Marking Certificates issued under the Medical Devices Regulation (2017/745, MDR) are accepted.

The application for registration of a medical device can include one of the following options:

• Single product
• A family of products (as long as all the products are from the same class)
• System (for using all parts together) provided that all products are from the same class.
• A group of products that includes several models of the same product and provided that all products are from the same class

Instructions for preparing an application for registration of medical devices in the Israel register via the declaration route

When sending registration requests (new/renewal/change), it is mandatory to send the request form in the PDF form and the accompanying ZIP file.

Instructions for filling out the application form:

• Filling in all the mandatory fields in the registration application form is very important.
• Be sure to fill in the company name and company number as they appear in the registration database of the Israel Medical Equipment Division.
• Make sure to fill out the medical device’s intended use, as defined by the manufacturer.
• All models appearing in this request must be specified in the form.
• In the “certificates and standards” table, it is mandatory to indicate the “certificate type,” the “issue date,” and the “expiry date” of the certificate

Note: if it is an FDA 510K approval, a 5-year validity must be specified.

The system automatically rejects a form that is not filled in as required.

Stay tuned – to be continued.

BioReg Services

Don’t hesitate to contact us if you need any assistance with AMAR registration or any other Regulatory Service

BioRegards,

Daniel