Israel Medical Devices Import Reform

The Medical Devices Market in Israel

Medical devices have traditionally been the leading healthcare sub-sector in Israel, both for local developers and for foreign exporters, and it accounts for approximately half of the total healthcare industry market share. The medical devices market size (as of 2022) is $2.4 billion, with a compound annual growth rate (CAGR) (2022-2028) of about 2%. The prominent segments of medical devices in the market are cardiovascular devices, hospital supplies, orthopedic devices, neurology devices, general surgery devices, minimally invasive surgical instruments and technologies integrated with imaging capabilities, dental instruments, equipment and technologies for pain management, physiotherapy, ozone & oxygen therapy. Following the global trend, medical devices in Israel is developing towards digital innovation, integrated IT capabilities for better accuracy, focus on tools improving physician-patient interface.

Medical Devices Import and Registration Reform

Starting in 2021, the Government of Israel has promoted several reforms in the importing process and standards for an array of industries. The goal of these programs was streamlining and improving the import process, as well as to reduce the cost of living in Israel. In alignment with the government’s policy, the Israeli Ministry of Health has launched a plan to revise the medical devices market in the country; the medical devices import reform is purposed to alleviate some of the regulatory burdens of the import process, make it quicker and more efficient, and ultimately increase the variety of the medical devices and equipment in Israel.

The new registration tracks are available for FDA or EU approved devices and equipment, and they divide products into ‘classes’ by levels of risk. For low-risk devices (class l), registration is self-declaration based. Low-to-medium risk equipment (class ll) qualifies for either self-declaration registration or a 60-day expedited registration, granted that the product is registered and marketed in a recognized country. Registration of class lll products - high risk equipment – remains unchanged.

For the detailed reform outline, please visit the Ministry of Health’s circular (Hebrew only)

The reform in medical devices registration and import is expected to ease the process of importing goods into Israel. Furthermore, the Ministry of Health estimates that the reform will lead to a decrease of up to 20% of regulatory expenses included in the medical devices import process, which will save the market roughly 90 million ILS (~$24 million) a year.

U.S. companies interested in learning more about the Israel medical devices market or other opportunities in Israel’s healthcare sector may contact Inbar.Marom@trade.gov.