Following the announcement issued by the Israeli Ministry of Health’s Medical Equipment Department (“MED”) in November 2023, on the automatic administrative extension of AMAR approvals (medical equipment registration approvals) until December 31, 2024, today the MED published a reminder, calling all relevant registrants to timely submit their registration renewal requests to the Medical Equipment Registrar, in the appropriate registration track.
As a reminder, the automatic registration extension until December 31, 2024 was provided to registered medical equipment whose AMAR approval expired between December 1, 2022, and December 30, 2024, as well as to medical equipment for which a registration renewal approval was granted, expiring between December 1, 2022, and December 30, 2024.
Thus, relevant registrants are recommended to prepare accordingly and submit a proper registration renewal request. In the absence of a registration renewal approval by December 31, 2024, the registrant will not be able to obtain an import approval for the relevant medical equipment. Relevant registrants can submit a renewal request in one of the following tracks:
Declaration Track
This track is intended for low-risk medical equipment (class I) and low-risk laboratory equipment (IVD), which is registered and marketed in recognized countries, and is based solely on the registrant’s declaration.
The registration is self-administered and immediate.
Registration under the Declaration Track opens on October 1st for the following year.
Fast Track
This track is intended for medium-risk medical equipment (class II) and medium-risk laboratory equipment (IVD), which is registered and marketed in recognized countries, and which meets the conditions specified in the fast track registration procedure.
Applicants may transfer open registration requests, which were previously submitted in the regular registration track, to the fast track registration process.
Regular Registration Track
This registration track is intended for medium-risk medical equipment (class II), high-risk medical equipment (class III), and laboratory equipment (IVD) in equivalent risk levels.
Additionally, the path is intended for medical equipment of Israeli manufacturers that is not registered and marketed in recognized countries.
In order to properly facilitate the registration, applicants must include in their application all necessary information and supporting documents, including valid regulatory approvals (for all products included in their registration request). Please also note that registration may be renewed based on expired CE approvals, which comply with European regulations, subject to the requirements set forth in the “Conditions for the Registration of Medical Equipment Based on European Regulatory Approvals Extended During the Transition Period to the New European Regulation,” published on MED’s website.
This publication is provided as a service to our clients and colleagues, with explicit clarification that each specific case requires individual examination and discussion in writing.
The information presented here is of a general nature and is not intended to answer the unique circumstances of any individual or entity. Although we strive to provide accurate and available information, we cannot guarantee the accuracy of the information on the day it is received, nor that the information will continue to be accurate in the future. Do not act on the information presented without appropriate professional advice after a comprehensive and thorough examination of the specific situation.
