Israeli Ministry of Health’s Notice regarding European Regulatory Approvals of Medical Devices
Earlier this week, the Israeli Ministry of Health (“MOH”) announced a pilot program broadening the scope of foreign marketing approvals that may be referenced when locally registering medical devices (the “Pilot”). The Pilot was initiated in light of the entrance into effect of the medical devices’ EU regulations (EU MDR).
The Pilot will enable the MOH to recognize, for purpose of registration of medical devices in the Israeli medical devices registry (the “Registry”), approvals issued by Notified Bodies*, from EU countries that are not included in the “recognized countries” list detailed in the Israeli Medical Devices Law, 5712 – 2012, provided that (i) such Notified Bodies are accredited by the EU in accordance with the MDR regulations; and (ii) the approvals/certifications used for the local registration in the Registry have been granted pursuant to the MDR regulations.
As of this date, the list of “recognized countries” includes the following countries: Austria, Australia, Italy, Iceland, Ireland, Belgium, United States, United Kingdom, Germany, Denmark, the Netherlands, Greece, Norway, New Zealand, Spain, Portugal, Finland, France, Canada, Sweden and Switzerland.
This Pilot will remain in effect until June 30, 2022. The MOH’s continuing policy on the subject matter will be re-examined based on the Pilot’s results.
* This language appears in the MOH announcement.
We note that the above is merely a short summary of the subject matter, and does not cover all relevant provisions of the guidelines. For additional information please contact your Gross & Co. attorney or one of the following Adv. Hili Cohen, partner and head of life sciences department (Hili@gkh-law.com) Adv. Tami Fishman, partner (Tamif@gkh-law.com), or Adv. Ofir Goldstein (Ofirg@Gkh-Law.com).
