Last Updated: October 2019
Current Market Trends
Current Demand Registration Process
Population: 11.4 million
GDP: USD $492.5 billion
Currency: Euro (€)
Language: Dutch, French, German
Belgium produces less than 10% of medical equipment consumed 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, the U.S. has a 28% 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 $2.6 billion in 2019. Over the past five years, this sector has seen an annual growth of approximately 4%.
The following data are in billions of dollars:
Total Market Size
Total Local Production
Imports from the U.S.
1 Euro = 1.1069 1.1297 1.180 1.14 (projected)
Belgium is a large transshipment hub resulting in large differentials. The country is also 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 among the most extensive and efficient in Europe. It covers nearly 100% of the population of 11.4 million inhabitants.
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. Universities, knowledge centers and university hospitals remain fertile ground for new entrepreneurship in health. However, many health startups find it difficult to source risk and growth capital in order to develop the business model at an international level.
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Belgium is an effective starting point for marketing medical equipment to the rest of Europe due to its geographical location, its effective healthcare system, and its 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 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.
Belgium’s current nomenclature and reimbursement system is under revision and a legal framework will be put in place so that telemonitoring, medical apps, and wearable medical technologies can be used and reimbursed soon. By the end of 2019, all hospitals should have an electronic record for each patient.
Belgium has approximately 800 companies manufacturing or distributing medical products. Many of these firms are small or medium-sized, employing an average of 20 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.
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.
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). 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. Some medical products, including surgical reusables and biomedical products, will be put in higher risk classifications.
It will also mean more unannounced inspections by notified bodies and Competent Authorities and additional requirements for the accreditation and supervision of notified bodies. All European notified bodies will lose their accreditation after the MDR and the European In-Vitro-Diagnostics Directive take effect and will have to be newly accredited within six months. Manufacturers of currently approved medical devices will have a transition time of three years (until May 26th, 2020) to meet the requirements of the MDR and five years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices. More information on the new regulation is available here: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_nl
Patient access to over-the-counter medical devices will be significantly improved under a new regulation that will allow distribution through supermarkets and other stores for the first time. From February 2019, various medical devices that were only allowed to be sold in pharmacies will become available in supermarkets and other stores. The change mainly concerns sterile consumables such as bandages and probes.
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.
There are no significant trade barriers on American medical devices.
Medica Duesseldorf – November 12-15, 2018
International Trade Fair for Medical Equipment
Procurement & Tenders
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)
1. Is the CE mark enough to export a medical device to Belgium?
No. The distribution of medical devices is regulated by Belgian law. Manufacturers and 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/).
2. What is the custom import health clearance?
All medical devices entering the Belgian market will be checked at customs, which will issue an import health and safety clearance. To obtain the clearance the following documents are required: Declaration of Conformity, CE certificate, Registration Number from the Belgian Medical Device Registry, and Product labeling (as required in the EU directive), including CE marking, authorized representative, Serial number/lot number, and Lot numbers (all lot numbers need to be reported, preferably on the invoice but if this is not possible on the bill of entry).
3. What are the major sales channels in Belgium?
Many Belgian distributors supply medical devices to hospitals and health professionals. A few companies focus on the distribution of rehabilitation and orthopedic supplies to the orthopedic retail sector including some pharmacies. Online sales are growing slowly.
Healthcare spending (including investment)
... as percent of GDP
10.3 % (2017 est.)
... of which spent on inpatient services (including long-term care)
... of which spent on investments
... of which spent on outpatient services
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
Number of hospital beds
... available beds per capita
5.7 per 1000 inhabitants
...of which in specialized clinics and rehabilitation centers
Number of surgical procedures
(Per 100,000 population)
...of which [top procedure]
… of which (Second Highest Procedure)
Colonoscopy with or without biopsy
… of which surgeons
… of which internists
…of which pediatricians
11,560,762 (2018 est.)
(Life expectancy men/women
male: 78.6 years (2018 est.)
female: 83.9 years (2018 est.)
3.4 deaths/1,000 live births
Percentoofopopulation older than 65
18.78% (2018 est.)
9.7 deaths/1,000 population (2018 est.)
...caused by [highest disease burden]
Heart and Vascular Diseases
...caused by [second highest]
Prevalence of Heart and Vascular diseases
Sources: CIA World Factbook, Statbel, Eurostat, IndexMundi, OECD, Federal Public Service (FPS) Health, Food Chain Safety and Environment
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