Medical device registration in Israel

To obtain access to the Israeli market for a to a medical device, registration with the Israeli Ministry of Health (AMAR) is required, according to Medical Devices law – 2012, #5772-2012.
Registration with AMAR is based on the registration of the device in one of the countries of the Global Harmonization Task Force (GHTF): Australia, Canada, Europe, Japan or United States.
The registration procedure is based on the ability to demonstrate, through certificates and documents, compliance with the standards and regulations of the GHTF countries where the medical device is already registered.
The registration procedure, according to Section 3 (d), must be carried out through an Israeli Registration Holder (IRH), that could be an Israeli citizen or a corporation established in Israel.
The registration documents must be in Ebrow.
Maytal experts, together with their partners located in Israel, can prepare the necessary documents and manage the relationships with AMAR in order to obtain the registration on behalf of the company.