Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
FAQs
U.S. Commercial Service Contact Information
Executive Summary
Belgium produces less than 10% of the total medical equipment supply it consumes domestically. This leaves the market open for heavy competition among suppliers from the United States (U.S.), Germany, France, and the United Kingdom (UK). According to the latest available figures (2020), the U.S. has a 23% share of total medical equipment imports into Belgium. U.S. suppliers are particularly dominant in the sectors of diagnostic imaging apparatuses, orthopedic and implantable products, and medical and surgical instruments.
The Belgian market for medical equipment and supplies is estimated at $3.4 billion USD in 2022. Between 2021 and 2026, the market for medical devices is expected to grow by 5.1%.
Belgium is a large transshipment hub. The country is a regional distribution center for many companies with more than two-thirds of medical device exports sent to other countries within the European Union (EU).
The Belgian Social Security System, which includes the Health Care System, is considered to be among the most extensive and efficient national healthcare systems in Europe. It covers nearly 100% of Belgium’s total population of 11.8 million citizens.
Belgium is also home to many HealthTech start-ups. Traditionally, the healthcare technology sector has had many spin-offs, but new businesses no longer must have a research background to be successful. University affiliated medical complexes and knowledge centers continue to be fertile ground for new entrepreneurship in health. However, many health startups find it difficult to source risk and growth capital in order to develop their business model at an international level.
Covid 19 had an impact on the use of medical software, telemedicine, ehealth and mhealth, especially during the first wave. The success of mhealth resulted in a legal framework allowing the reimbursement of all mobile health applications from prevention to diagnosis and aftercare, providing they comply with certain standards such as CE mark and Privacy. There is currently a strong push from the sector federation (bemedtech) to also apply the legal framework for digital therapeutics (DTx). Digital Therapeutics (DTx) are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. They have to comply with the 2017/745 (EU MDR).
Market Entry
Belgium is an effective starting point for marketing medical equipment to the rest of Europe due to its geographical location, effective healthcare system, and relatively open attitude regarding procurement. As a key distribution hub for many multinationals, the value of Belgian medical imports is significantly higher than the value of the market itself.
To enter the medical equipment market in Belgium, American suppliers should be familiar with the EU directives concerning the registration, marketing, and health/safety standards required throughout Europe, as well as regulations specific to Belgium. It is therefore advisable to work with a local partner/distributor. See the EU Healthcare Resource Guide for more information.
The European Directive 2004/18/EC on public procurement applies to all hospitals for the purchase of medicines and medical devices. The directive requires that for purchases over the threshold of €200,000, a European tender should be released and published in the supplement of the Official Journal of the European Union. Procurement with a threshold between €85,000 and €200,000 requires a tender in Belgium and publication in the Official Journal.
Current Market Trends
Belgium’s healthcare system is currently facing several challenges. A growing elderly population and higher health expectations have and will have an important impact on healthcare expenditures in the coming years. In this context, the government is looking at various cost-saving measures. Thus, innovative technologies and equipment offering cost savings will have strong market potential. Diagnostic products to detect chronic diseases in their early stages, orthopedic products, homecare products, and obesity and diabetes products are in high demand.
Over the next few years, major measures are expected to be introduced in Belgium to continue improving the quality of care and efficiency of the health system. Among them are the continuation of the hospital landscape reform, mental health care reforms and integrated care projects, the development of a national health research system, the reform of the national fee schedule, and the implementation of a new law on quality practice in health care.
Best Prospects
Although there are several Belgian innovative companies offering Digital Therapeutics (DTx), there is still room for new DTx applications such as mental care.
There is a focus on RWD (real World Data and Integrated care) but the landscape is very fragmented with hospitals using different internal systems. To realize the full potential of e-Health and m-health, the overall healthcare ecosystem must be reformed. Swift data transfers between all stakeholders, such as hospitals, patients, public authorities, research institutes and industry, supported by an effective regulatory framework, can help the effective use of ‘big data’. A fully informed healthcare network provides for more coherent communication and efficient decision-making. Although e-Prescription and electronic records are finally implemented, there is still a need for interoperability, allowing healthcare providers to share patient information.
Innovative technologies and equipment that can help cut costs.
Diagnostic products to detect chronic diseases in their early stages, orthopedic products, homecare products, obesity and wound care products are in high demand.
Market Size
Healthcare spending (including investment)
… as percent of GDP
10.7 % (2020 est.)
… of which spent on inpatient services (including long-term care)
5.4% (2019)
…ofo whicho spento ono pharmaceuticals/consumables
1.8% (2019)
… of which spent on investments
NA
… of which spent on outpatient services
1.9% (2019)
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
164
…Public
49
Private
115
Number of hospital beds
63,962
… available beds per capita
5.6 per 1000 inhabitants
…of which in general hospitals
52,565
…of which in specialized clinics and rehabilitation centers
17,604
Number of surgical procedures
(Per 100,000 population)
20,712
…of which [top procedure]
Cataract
… of which (Second Highest Procedure)
Colonoscopy with or without biopsy
Physicians
47,808
… of which surgeons
9,010
… of which internists
1,397
…of which pediatricians
2,045
Dentists
8,697
Demographics
Population
11,847,338 (2022 est.)
(Life expectancy men/women
male: 78.6 years (2019 est.)
female: 83.1 years (2019 est.)
Infant mortality
3.4 deaths/1,000 live births
Percento ofo populationo older than 65
19.6% (2021 est.)
…projection, 2030
22.4%
Annual deaths
11.0 deaths/1,000 population (2020 est.)
…caused by [highest disease burden]
COVID-19 (2020)
…caused by [second highest]
Heart Disease
Prevalence of Heart and Vascular diseases
16.5% (% of Total Deaths)
Sources: CIA World Factbook, Statbel, Eurostat, IndexMundi, OECD, Federal Public Service (FPS) Health, Food Chain Safety and Environment
Main Competitors
Belgium has approximately 800 companies manufacturing (50) or distributing medical products. Many of these firms are small or medium-sized, employing an average of 10 to 50 people. Belgian suppliers do well in niche markets, including anesthesia equipment, diagnostic imaging, cancer diagnosis, and teleradiology.
Belgium is home to many subsidiaries of American companies such as GE Medical Systems, 3M, Abbott, Baxter, Johnson & Johnson Medical, Medtronic, Becton Dickinson, Boston Scientific, Cyberonics, and Edwards Lifesciences.
Current Demand
There is a trend towards treating chronic diseases with new technologies allowing patients to stay home, minimizing the impact on their quality of life. As such, innovative technologies, minimally invasive and non-invasive equipment, user-friendly homecare products, medical software, telemedicine, e-health and m-health are sectors with a strong market potential.
Additionally, orthopedic and implantable products, as well as diabetes products, are in demand.
Registration Process
The distribution of medical devices is regulated by Belgian law. Distributors of medical devices, including active implantable devices, should notify the Federal Agency for Medicines and Health Products (http://www.fagg-afmps.be/en/human_use/health_products/medical_devices_accessories/ ).
Since 2014, implantable medical devices must be registered consistently during the time the product is introduced to the Belgian market through to implanting the medical device. Furthermore, a databank will collect information regarding all implantable medical devices that are available on the Belgian market, allowing patients to check if an implant is registered or not.
Medical devices must bear the CE marking for conformity when marketed. Custom-made implantable and non-implantable devices and devices for clinical investigation do not require CE marking. If a notified body has been involved in verifying the procedure of conformity, the CE mark must be accompanied by a four-digit number indicating the notified body. Information on CE Marking can be found here: http://export.gov/europeanunion/eustandardsandcertification/index.asp
The new European Medical Device Regulation (MDR) was adopted in April 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). On 26 May 2021, the MDR came into full force. The goal of the MDR is to further improve patient safety with increased traceability and to tighten regulations for clinical trials, particularly for high-risk products. Under the new regulations, both medical devices and in-vitro diagnostic medical devices are divides into four risk categories. Depending on the risk class of the product, a different conformity assessment procedure is foreseen before the product can be place on the EU market. In case of medium or high-risk classes, Notified Bodies are involved in the process.
Reimbursement
Belgium has a centralized system of reimbursement. In order to be eligible for reimbursement under the national social security scheme, medical devices need to be included on a list of reimbursable medical services and devices known as the Nomenclature. Inclusion on the list and the level of reimbursement is determined by the national health insurer INAMI in conjunction with the federal Ministry of Health (MoH).
The current trend is to regulate reimbursement policy much more strictly as part of a drive to increase the cost effectiveness of the healthcare system. At the same time, efforts are being made to facilitate the introduction of innovative technology which can demonstrate a clear health/cost benefit over existing medical practice. To this end, health technology assessment, involving detailed analysis of cost effectiveness and health outcomes of alternative treatments, is increasingly used to determine reimbursement policy.
Barriers
There are no significant trade barriers on American medical devices.
Procurement & Tenders
Healthcare Procurement:
http://justitie.belgium.be/nl/overheidsdienst_justitie/organisatie/belgisch_staatsblad (Procurement with a threshold between €85,000 and €200,000)
http://ted.europa.eu/TED/main/HomePage.do (Procurement >€200,000)
FAQs 1. Is the CE mark enough to export a medical device to Belgium? http://www.fagg-afmps.be/en/human_use/health_products/medical_devices_accessories/ ).
2. What is the custom import health clearance?
3. What are the major sales channels in Belgium?
U.S. Commercial Service Contact Information
Name: Danny Dumon danny.dumon@trade.gov
