ASIA
ISRAEL
Market Information
Israel ’s healthcare expenditure anticipates a continuous rise from 2024 to 2028, amounting to a total increase of $10.8 billion (+26.85 percent). Following thirteen successive years of growth, expenditures are expected to hit $51.2 billion in 2028, marking a new peak.
Market Trend: About 9.8 million people, which is 100% of the population, are covered by health insurance.
Israel’s medical equipment market is projected to reach US$3.25bn in 2024. It is expected to show an annual growth rate (CAGR 2024-2028) of 6.49%, resulting in a market volume of US$4.18bn by 2028.
In Israel, oversight of medical devices falls under the jurisdiction of the Medical Device Division of the Ministry of Health, known as AMAR. Created under the Medical Equipment Law of 2012, AMAR is tasked with the registration and authorization of medical devices. According to Israel's Ministry of Health, the inception of the Medical Device Division dates back to 1993 when it was originally formed as the Medical Device Unit. Its responsibilities encompass licensing and oversight of medical devices and equipment, facilitating the registration process, issuing import permits, and providing relevant guidelines and protocols.
Medical Device Regulation
Medical Device Division (AMAR), under the MOH.
Regulation of medical devices done under the Israel’s Registration and Renewal of Medical Devices Regulations 2013 and its Medical Equipment Law of 2012.
Classification, Fees, Timeline
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Product Registration Routes
Class I, II, III
Useful Information
Validity of License: Licenses issued by AMAR are subject to the expiry date of the medical device EC certificate.
License transfer: A new application is needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
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