Ver 3.0 (14/07/24) Marketing Declaration Template To Whom It May Concern Please be advised that the Israeli Ministry of Health requires from all the manufacturers and importers of medical devices to issue a declaration confirming the registration of the devices and compliance with all required laws and regulations. In addition to the signing of the declaration by the foreign manufacturer our guidelines for the registration of medical devices require the local authorized representative / importer to provide us with the following information (please print on a company letterhead): Marketing Declaration Device Name: _______________________________________________________ 1. The relevant countries where the specific request is issued. (Only those countries: USA, EU, Canada, Australia, New Zealand, UK [please mention in what country]) 2. Quantities of sales per country in the above mentioned countries: Quantities of sales per country Country/ies ☐ Less than 50 ☐ Between 50 to 200 ☐ Between 200 to 1,000 ☐ Between 1,000 to 10,000 ☐ More than 10,000 ☐ More than 100,000 ☐ Millions Additional Information to be provided only for a "fast route" registration application:
