Regulatory Authority
Medical Device Division of the Israeli Ministry of Health (AMAR).
Classification
Israel does not have its own classification system but it recognizes USA, Europe, Australia and Japan ones.
Quality system
ISO 13485:2016
Under the new regulation, which came into force in 2012, all Medical Devices manufactured or marketed in Israel must be registered with AMAR.
The medical device registration procedure is based on first obtaining approval in one of the five founding countries of the Global Harmonization Task Force (GHTF) such as Australia, Canada, Europe, Japan or the United States. As regards manufacturers who have already obtained approval for their devices in one of the aforementioned markets (particularly Europe and the US), registration is almost automatic. As regards cardiac catheters and devices, the approval of the Cardiological Association is required.
Applicant
The registration procedure must be carried out through an Israeli Registration Holder (IRH), similar to the US Agent or the Mandator in Europe. The approval will be on behalf of the Local Representative.
Validity
Licenses issued by AMAR are subject to the expiry date of the medical device EC certificate. As regards devices with only FDA approval, expiration dates are more flexible.
Labelling and documentation language
The following documentation must be submitted in Hebrew.
Some official certification documents, for example, do not need to be translated if they are in English.
In case the medical device is intended for domestic use, the labelling and instructions for use must be provided in English, Hebrew and Arabic.
In the event that the product is intended for professional use only within health facilities, the labelling and instructions for use may only be in English.
Useful information
AMAR registration requires medical device prior approval in one of the Global Harmonization Task Force (GHTF) founding countries.
