Israeli Ministry of Health – Medical Devices’ Registration Reform |
The Israeli Ministry of Health (the “ MOH”) recently published the full framework of the reform in the registration procedure of medical devices (the “ Reform”), implementing different classifications for medical devices,
and different procedures for receiving marketing approvals for the various classes of medical devices. See our previous legal update on the matter here.
In the recent publication, the MOH provided the detailed framework of the Reform. The table below provides a summary of the Reform:
|
| Classification | Registration | Renewal | Changes | Implementation Schedule
| Class I
| Declarative | Declarative | Declarative | Applied and in effect | Class II
FDA | - Regular Route - Fast route for FDA-approved devices that have been in use in the U.S in the last 4 months, will be registered within 45 business days unless a decision is actively made not to approve. | Declarative | - Declarative (non-substantial) - On a fast route (substantial)
| - Changes via declaration starting April 1, 2024 - Non-substantial changes via declaration starting April 1, 2024 - Fast route for registration and substantial changes starting April 1, 2024 | Class IIa
EU (*) | - Regular route - Fast route for devices approved by a recognized country that have been in use in such country for the last 4 months will be registered within 45 business days unless a decision is actively made not to approve. | Declarative | - Declarative (non-substantial) - On a fast route (substantial)
| - Changes via declaration starting April 1, 2024 - Non-substantial changes via declaration starting April 1, 2024 - Fast route for registration and substantial changes starting April 1, 2024
| Class IIb
EU (**) | - Regular route - A fast route for devices approved in two independent regulatory authorities (e.g., EU and FDA), that have been in use in a recognized country for the last 6 months, will be registered after 60 business days unless a decision is actively
made not to approve. | Declarative, accompanied by a post-marketing tracking report | - Declarative (non-substantial) - On a fast route (substantial)
| - Changes via declaration starting April 1, 2024 - Non-substantial changes via declaration starting April 1, 2024 - Fast route for registration and substantial changes starting April 1, 2024 | | Class III | Regular route
| Submission of an application, accompanied by a post-marketing tracking report | Declarative (non-substantial) | Non-substantial changes via declaration starting April 1, 2024 |
(*) Including laboratory equipment IVDR (B) or the equivalent per the IVDD directive.
(**) Including laboratory equipment IVDR (C) or the equivalent per the IVDD directive.
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Please note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the Reform. |
The content in this communication is provided for informational purposes only and is not intended to be comprehensive. It does not serve to replace professional legal advice required on a case by case basis. |
For further questions, please get in touch with: |
Electra Tower, 98 Yigal Alon St., Tel Aviv, 6789141, Israel Round Tower, 1 Azrieli Center, Tel Aviv, 6701101, Israel Mittelstrasse 14, 8008 Zurich, Switzerland |
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