Current Regulations in Israel and the IRH (Israeli Regulations Holder) Role

The Israeli parliament, passed a new law in May 2012 regulating the registration of medical devices. Under this legislation, all medical devices manufactured or marketed in Israel must be registered with the Ministry of Health registrar (AMAR - The Medical Device Division of the Israeli Ministry of Health) who is responsible for registering and supervising medical devices in Israel.

The Health care system in Israel, one of the largest in the Middle East, is both universal and compulsory ensuring that all residents of Israel are covered.  It is administered by several HMOs with funding from the government.  All Israeli citizens are entitled to the same uniform, government controlled, benefit package (sal briyut), regardless of which organization they are a member of and regardless of their financial means. 

Israel has become recognized worldwide for its numerous innovative and cutting-edge contributions in medical technology. These advances have been enabled, in part, by a close network of cooperative relationships between medical research institutions and industry. The country has the highest proportion of new patents in this sector and number of physicians per caita. There are nearly 1000 companies in this field.

Israel’s strength in this sector come from multi-disciplinary capabilities, which bring together medicine, engineering, clinical expertise and software. Some of the world’s leading universities with renowned R&D faculties, leading edge medical centers, and a remarkable high-tech sector combined with a spirit of entrepreneurship have all contributed to the dynamic growth in medical devices.

In recent years Israel’s medical device sector is attracting increasing amounts of foreign investment. This is achieved through VC funds, IPOs and direct investments from major US and international companies such as: Johnson & Johnson, Boston Scientific, Medtronic, Bayer and Guidant.

According to the new Law applications for registration shall be done only by an Israeli citizen or by an independent professional and skilled third party established in Israel - The Israeli Registration Holder (IRH) who is responsible for the interface between the AMAR division and the manufacturer, prepare and submit the registration applications, reporting of adverse events, perform Post Marketing activities and many other activities.

 Adi Ickowicz, MedicSense