Executive Summary
Israel’s public healthcare system is advanced by international standards. Israel spends 7.5% of its Gross Domestic Product (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 open to adopt new, cost effective technologies and procedures. Many Israeli doctors receive training in the United States (U.S.) 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 age-based screening standards. In 2018, the Ministry of Health (MoH) announced it will establish new procedures to shift from hospital care to homecare. The MoH also continues to improve the national patient medical record system, both for the benefit of the patient and for clinical research purposes.
Israel’s healthcare technology market is estimated at $6.2 billion, of which devices account for $2.4 billion and pharma $3.8 billion. Imports make up over 65% of the device market and about 60% of the pharma market. Top medical device imports are surgical instruments and other medical electronics, lab reagents, diagnostic equipment, and catheters. Top pharma imports include medicaments in measured doses for retail sale, antisera and blood fractions and immunology products. The U.S. is Israel’s largest single-country source of medical devices and pharmaceuticals, followed by China and Germany. Total imports of medical devices from the U.S. to Israel in 2018 accounted for $458 million. Total imports of pharmaceutical products from the U.S. to Israel in 2018 accounted for $373 million. Many U.S. multinationals also have production lines in Europe; therefore, the U.S. market share is larger when considering imports of U.S. brands that are being produced in Europe or shipped to Israel via a European country.
Israel is a global technology research and development center. Israel’s strength in this sector stems from its interdisciplinary 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 Cost, Insurance and Freight (CIF) landed cost.
Current Market Trends
Digital Health
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 MoH 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 Emergency Room (ER) queue management application that monitors the progress of a patient’s treatment in the ER and increases the control on ER loads.
Aging Population
The aging population creates multiple challenges for Israeli society. The need to cope with the steadily increasing number of elderly people with dementia is one of the major challenges for Israel’s healthcare system. The MoH has 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, including government ministries, the health plans, and other organizations. The strategic plan aims 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.
Increasing Private Health Spending
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 has grown. Private spending is composed of payments for dentistry (most dentistry in Israel is not included in the state health system), supplementary and commercial health insurance, private care, purchases of medications, deductible payments, and purchases of medical equipment.
The rate of public spending on healthcare 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 for non-essential CT and MRI screening.
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
Israel’s Healthcare Technologies Market Size and Trade Data ($ billion)
| Year |
2015 |
2016 |
2017 |
2018 |
Change % 2015-2018 |
| Total Local Production |
10.8 |
12 |
12 |
11.2 (Est) |
+1.8% |
| Total Exports |
9 |
10.3 |
10 |
8.9 |
-1% |
| Total Imports |
3.75 |
3.8 |
3.8 |
3.925 |
+4.5% |
| Imports from the U.S. |
0.464 |
0.490 |
0.530 |
0.832 |
+44% |
| Total Market Size |
5.3 |
5.5 |
5.8 |
6.2 |
14.5% |
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 that help patients monitor their health at home. Wound care, advanced diagnostics, and minimal invasive procedures continue to be a high priority in the public healthcare market. In addition, a well-developed private health sector 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 and oxygen therapy, OR equipment and cost-saving single use products, point of care diagnostic kits, and wound management technologies.
Registration Process
The MoH has an overarching regulatory and policymaking role. U.S. companies interested in exporting medical devices or pharmaceuticals to Israel need to appoint a local distributor, agent or other legal representative to register their products. The device registration application should be accompanied by a 510(k), Pre-Market Approval (PMA) or an Investigational Device Exemption (IDE). Pharma registration is more complex and requires additional testing and clinical investigation on top of the product file and FDA certification. The average time it takes to obtain a market approval from the MoH is 150 days for medical devices and about 360 days for pharmaceuticals.
Regulations
Medical Devices, including biologics that fall under a Biologics Certificate (BK) process at the USA Food and Drug Administration (FDA) Center for Biologics, must be registered with Israel’s MoH 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 MoH. 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. If a product is approved by the FDA, it can be registered with 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 MoH, 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 U.S. If such a 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 and six months, and the MoH will determine what type of testing is needed.
Product registration supported by 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 MoH. The application should be submitted on the special form designated for this purpose and include the following:
- Name and address of the manufacturer, and of the importer as applicable
- Description of the intended use of the medical device and of its medical indications.
- Technical details of the medical device and of its components, and if the device or the components are not new, information should be provided on the date of renovation.
- Certificate attesting to the safety of the device, issued by a competent authority of one of the following countries: Australia, Canada, European Community (EC), Member States (MSs), Israel, Japan, USA
- Information on any risk which may be associated with the use of the device (including precautionary measures to be taken).
- Instructions for use of the device in Hebrew; the MOH may allow the instructions to be in English for certain devices.
- Details of the standards to which the device complies.
- Description of the technical and maintenance services, including periodic checks and inspections.
- Declaration, as appropriate: of the local manufacturer/importer, and of the foreign manufacturer.
Note: A license (marketing authorization) for a medical device, granted by the MoH, 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 device, specific requirements exist for the products detailed hereunder, which should be included in the application:
- Tissues, including corneas, for transplantation into human beings
- Medical devices containing components derived from animal origin
- Kits for diagnosis of HIV infection
- Bare metal as well as Drug Eluting Coronary stents
Registration costs the equivalent in ILS 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 MoH twice a year. Medical devices are classified according to FDA guidelines.
Technical Standards
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 systems. 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.
Labeling
Medical devices must have Hebrew labeling stating the country of origin, name and address or the manufacturer, and name and address of the Israeli importer. Biological materials should additionally be 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:
- Name and address of the manufacturer
- Name and address of the importer
- Medication element needed
- U.S. Israel Free Trade Agreement & Customs Evaluation
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 MoH and the Clalit Health Fund as of January 1, 1994 and has been regularly updated by the MoH, 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:
- Diagnosis, consultation and medical treatment
- Medications according to a list, some of which are provided only for a particular indication
- Hospitalization in a general hospital
- Rehabilitation, including hospitalization
- Accessories and medical supplies
- Medical services in the work place
There are several health services that, as of now, have not been transferred to the health funds and remain the responsibility of the state:
- Preventive medicine – well-baby clinics and inoculations
- Certain general rehabilitation devices, walking and other mobility devices, for which the
- Ministry of Health participates in the cost
- Health services for schoolchildren
Barriers
All tariffs on trade between the U.S. and Israel have been eliminated since 1995. The Israel MoH 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 MoH, 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.
U.S. Commercial Service Contact Information
Name: Yael Torres
Position: Healthcare Industry Specialist
Email: yael.torres@trade.gov
Phone: 972-3-519-8522
