Summary Market Entry Current Market Trends Main Competitors Current Demand
Registration Process Reimbursement Barriers Trade Events CS Contact
Capital: Jerusalem
Population: 8.6 million
GDP: $334 Billion
Currency: Israeli Shekel
Language: Hebrew/Arabic
Summary
Israel’s public healthcare system is well-advanced by international standards. Israel spends 7.5% of its GDP on the public healthcare system, providing universal healthcare coverage to its entire population via four health management organizations and a network of hospitals, community clinics and specialized doctors. Israeli healthcare facilities are modern and are open to adopting new, cost-effective technologies and procedures. Many Israeli doctors receive training in the United States and maintain personal and professional relationships with U.S. colleagues at major medical centers.
Israel’s healthcare policy makers have been focusing on promoting healthy nutrition and lifestyle, preventive medicine and early detection of cancer and other systemic and degenerative diseases. The public healthcare system is also promoting age-based diagnostic tests.
Israeli importers and distributors of medical and pharmaceutical products reported over $3.8 billion in sales in 2016. The U.S. share was about 14% at $530 million. Local distributors are looking for innovative healthcare technologies that help reduce cost and improve patients' healing prospects.
Israel is a global technology research and development center. Israel’s strength in this sector stems from inter-disciplinary capabilities, which bring together medicine, clinical expertise, materials science, electronics, software expertise and engineering know-how. Israeli development centers of multinational companies have an annual turnover of billions of dollars.
Market Entry
Under the U.S.-Israel Free Trade Agreement (FTA), American goods face no import duties upon entering Israel's market. Proper Shipping documents and an Invoice Declaration are required in order to benefit from the FTA. Every product is still subject to 17% Value-Added-Tax (VAT). VAT is levied on the CIF landed cost. For additional market entry guidelines please write to: yael.torres@trade.gov
Current Market Trends
Israel’s starting point in the digital world is especially good. There is a well-developed infrastructure and high-tech industry that offers innovative tools and applications. The Ministry of Health and Digital Israel are leading a national program that aims to harness and leverage the opportunity inherent in the digital revolution and progress of information and communication technologies. The system connects caregivers and allows them to watch the diagnoses and treatments performed by other practitioners in different organizations. The program also includes the deployment of an ER queues management application that notifies the progress of a patient’s treatment in the ER and increases the control on ER loads.
The aging population creates multiple challenges for Israeli society. The need to cope with the steadily increasing number of elderly with dementia is one of Israel’s healthcare system’s major challenges. The Ministry of Health developed a national strategic plan to address Alzheimer’s and other types of dementia and age-related chronic diseases. The plan offers a holistic perspective and emphasizes collaboration among all relevant agencies: government ministries, the health plans and other organizations. The Strategic Plan aspires to cope with key issues that make it difficult for the current service system to provide an appropriate response to the unique needs of elderly patients.
The proportion of private financing in national health spending in Israel, on top of the health tax, continues to rise. According to the Israel Central Bureau of Statistics, the proportion of private spending is 40%, making it one of the highest rates in the Organization for Economic Cooperation and Development (OECD), in which the aggregate rate of private health spending is only 28%. The trend is clear and consistent, resulting from an erosion of the public healthcare system's resources. Meanwhile, the public's spending on health insurance and private medicine in general grew. Private spending is composed of payments for dentistry (most dentistry in Israel is not included in the state health basket), supplementary and commercial health insurance, private care, purchases of medications, deductible payments and purchases of medical equipment.
The rate of public spending has not changed since 1995. The government refrains from increasing the health system's financial resources, despite population growth and technological requirements. Among other things, every purchase of an MRI machine, or a machine used in cancer radiology treatments, requires a special license. The rationale for this policy on diagnostic imaging devices like an MRI may very well be understandable, since increasing the supply can increase the demand, including unnecessary diagnoses.
Main Competitors
Israel is a sophisticated and mature market. U.S. suppliers face intense competition and should therefore be ready to compete and support their local distributors through educational presentations, material and lobbying/advocacy. Major multinationals and large companies have established direct sales and marketing offices in Israel. Other exporters operate through local distributors. There are hundreds of medical distributors that are well-established throughout the country.
Current Demand
Israel has a growing elderly population and limited resources. As a result, the demand is for cost-saving products and for products which help patients monitor their health at home. Wound care, advanced diagnostics and minimally invasive procedures continue to be a high priority in the public healthcare market. In addition, well-developed private sector healthcare in the areas of dental, eye laser surgery and plastic/aesthetic surgery keep up the demand for advanced medical instruments and appliances. Israel has an excellent digital health tech base and is a world leader in mobile and E health implementations. Opportunities exist however, in further advancing drug monitoring and disease surveillance. Other best sales prospects include minimally invasive surgical instruments and technologies that are integrated with imaging capabilities, cardiology equipment, equipment and supplies for plastic surgery, smart implants, dental instruments, equipment and technologies for pain management, physiotherapy, ozone & oxygen therapy, or equipment & cost-saving single use products, point of care diagnostic kits and wound management technologies.
Registration Process
Market access is fairly clear for U.S. FDA and CE Marked medical products. U.S. companies interested in exporting to Israel need to appoint a local distributor, agent or other legal representative to register their products with the Israel Ministry of Health (MOH). The device registration should be accompanied by a 510(k), Pre-Market Approval (PMA) or an Investigational Device Exemption (IDE). The Ministry of Health has an overarching regulatory and policy making role. The average time it takes to obtain a market approval from the Ministry of Health is 120 days.
Medical Devices, including biologics that fall under a Biologics Certificate (BK) process in the USA Food and Drug Administration (FDA) center for biologics, must be registered with Israel's Ministry of Health (IMOH) Medical Device Registry before they can be sold in the country. Companies wishing to export medical equipment or devices to Israel must have a local Israeli agent or distributor who should request a pre-marketing approval from the IMOH. The request should be accompanied by one of the following documents: the U.S. FDA 510(k), or Pre-Market Approval (PMA). Biological devices fall under medical device classification and require FDA's BK. In most cases CE and Canadian documentation are also acceptable by the IMOH. If a product is approved by the FDA, it will be registered by the MOH with no further testing. However, electro-medical devices must be tested at the Standard Institute of Israel (SII) for safety and for compliance with the Israeli electric system. In most cases the SII does not accept certifications from other countries.
For any imported medical device, the Israeli importer/agent must submit a registration application to IMOH, Department of Medical Devices. The application should include (if available) a certificate issued by a competent authority of one of the following countries: Australia, Canada, European Community (CE) Member States (MSs), Japan, or the United States of America. If such certificate is not available, the registration process may still be available in some cases (usually for lower regulatory class devices) but will take longer, between two to six months, and the IMOH will determine what type of testing is needed.
Product registration supported by an existing FDA documentation usually takes approximately four months. The application for registration of a medical device shall be submitted to the Department of Medical Devices at the Ministry of Health. The application should be submitted on the special form designated for this purpose and shall include the following:
Note: A license (marketing authorization) for a medical device, granted by the IMOH, is valid for up to five years from the date of registration of the device, except for implants with a life-supporting function, for which the validity is for two years from the date of registration.
In addition to the usual requirements for the registration of medical devices, as applicable to the particular device, specific requirements exist for the products detailed hereunder, which should be included in the application:
Registration costs the equivalent in NIS of $300 per single item, and $1,500 per catalog registration. Catalog registration is, for example, on an EKG device with different channels and accessories. Registration fees are updated by the IMOH twice a year. Medical devices are classified according to FDA guidelines.
The Standard Institute of Israel (SII) is the agency responsible for the development of most product standards, compliance testing, and certification of products and industry quality assurance system. Israel has stated its intention to follow international standards whenever possible. However, it has been reported that some standards still exist that tend to favor domestic producers over foreign manufacturers. Medical devices must comply with Israel's electric standard of 220 V, 50 Hz.
Medical devices must have Hebrew labeling stating country of origin, name and address of the manufacturer, name and address of the Israeli importer. Biological materials should be additionally labeled with their content, weight, and volume in metric units. Implantable medical devices require mandatory labeling in the patient's file. The labels must contain the following information:
Under the U.S.-Israel Free Trade Area Agreement (FTAA), American goods face no import duties upon entering Israel's market. However, products are still subject to Value Added Taxes (VAT) and purchasing taxes. In order to benefit from the FTAA, products must have a U.S. Certificate of Origin for Exporting to Israel (CO). VAT is levied on the CIF landed cost plus uplift
(if applicable) plus purchase tax (added to some products, primarily luxury and consumer items).
Reimbursement
Israel’s Reimbursement System is called “The Healthcare Basket”. It includes all the services, medications, supplies and medical equipment that the insured is entitled to receive according to the National Health Insurance Law. It was originally determined based on the health services that were provided by the Ministry of Health and the Clalit Health Fund as of January 1, 1994 and has been regularly updated by the Ministry of Health, on the basis of recommendations by a public committee.
The National Health Insurance Law describes the following fields of service to be included in the healthcare basket for which the health funds (HMOs) are responsible:
There are several health services that, as of now, have not been transferred to the health funds and remain the responsibility of the state:
Barriers
All tariffs on trade between the U.S. and Israel have been eliminated since 1995. The Israel Ministry of Health uses the FDA’s standards for the purpose of issuing licenses. Import permit procedures for American-made, USFDA-approved medical equipment are easily facilitated. There are many suppliers so U.S. companies should be ready to compete.
Procurement & Tenders
The Ministry of Health, its group purchasing organization – SAREL, and the four HMOs publish procurement requests and tenders on their websites. Tenders are published in the Hebrew language. U.S. companies that wish to participate would be required to engage with an Israeli partner.
Ministry of Health current tenders
SAREL: http://www.sarel.co.il/auction/
Clalit HMO Tenders
Maccabi Health Services Tenders
Trade Events
Name of Event: The Medical and Health-Care Device Development
Date: November 6, 2018
Location: Avenue Convention and Events Center, Airport City, Israel Website: https://10times.com/meditech-tel-aviv-yafo
Name of Event: Innovations in Cardiovascular Interventions (ICI) Meeting
Date: December 2-4, 2018
Location: Tel Aviv
Website: http://icimeeting.com/
Name of Event: Biomed Israel 2019
Date: May 2019
Website: http://biomed.kenes-exhibitions.com
Government Links
U.S. Commercial Service Contact Information
Name: Yael Torres
Position: Healthcare Industry Specialist
Email: yael.torres@trade.gov
Phone: 972-3-519-8522
Best Prospects
Point of Care monitoring and diagnostics - Israel has a growing elderly population and limited resources. As a result, the most significant demand is for cost-saving products and for products that help patients monitor their health at home. Awareness for preventive medicine and acceptance of diagnostic procedures into the reimbursement list opened the market to advanced diagnostic procedures. This shift includes early detection of breast and colon cancer and a set of standard, age-based diagnostic procedures.
Market Size
Healthcare spending (including investment)
$25 billion
... as percent of GDP
7.5%
... of which spent on pharmaceuticals/consumables
$3.8 billion
Hospitals, Procedures, Healthcare Professionals
Number of hospitals:
354
…Public
172
…Private
182
Number of hospital beds
44,715
... available beds per capita
.005
...of which in general hospitals
15,487
...of which in specialized clinics and rehabilitation centers
29,228
Physicians
35,000
Dentists
6,545
Demographics
Population
8.8 million
Life expectancy men/women
80.3/84.1
Infant mortality rate
3.1 per 1,000 live births
Percent of population older than 65
15%
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