Israel Medical Device Strategy Report
The Israeli Ministry of Health's Department of Medical Devices (AMAR) is responsible for oversight of the country's medical device market. However, the Israeli medical device regulatory system is based on prior marketing authorization in and one of the five founding Global Harmonization Task Force countries: Australia, Canada, Europe, Japan, or the United States.
Most medical devices require registration with AMAR prior to commercialization, though some types are exempt. In addition to device registration, most devices also require an import permit, issued by AMAR, in order to pass Customs.
Let Emergo assist you in evaluating the Israeli medical device regulatory framework as it applies to your device(s).
Leveraging our global network of consultants, as well as industry and regulatory contacts, Emergo can provide in-depth analysis of multiple medical device markets, including Israel. The following topics are covered in our Regulatory Pathway reporting service for the Israeli market:
- Regulatory Background on AMAR and the Israeli Ministry of Health
- Product Assessment
- In-Country Representation Requirements in Israel
- Medical Device Registration Requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Regulatory Roadmap for Israel
- Post-Market Obligations