Healthcare Resource Guide: Belgium

 

Belgium Statistics

Summary
Market Entry

Current Market Trends

Main Competitors


Current Demand
Barriers

Registration Process

Trade Events

CS Contact

Capital: Brussels Population: 11 million
GDP*
: USD 527.8 billion (2014)
Currency:
Euro (€)
Language
: Dutch, French, German

Summary

Belgium produces less than 10 percent of medical equipment consumes domestically. This leaves the market open for heavy competition among suppliers from the U.S., Germany, France and U.K. According to the latest available figures, the U.S. has a 28 percent share of total medical equipment imports into Belgium. U.S. suppliers are particular dominant in sectors of diagnostic imaging apparatus, orthopedic and implantable products and medical and surgical instruments.

The Belgian market for medical equipment and supplies is estimated at $2.8 billion. Over the past 5 years, this sector has seen an annual growth of approximately 4 percent. 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 percent of the population of 11 million inhabitants.

Market Entry

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. Belgium is a distribution center for many multinationals: products are imported into Belgium and exported to other European countries.

In order 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.

Since July 1, 2013, 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 a strong market potential. Orthopedic products, homecare products, obesity and diabetes products are in high demand.

Furthermore, there is a trend towards treating chronic diseases with new technologies allowing patients to stay home and minimizing the impact on their quality of life.  Medical software, telemedicine, ehealth and mhealth are as a consequence sectors with a strong market potential.  Belgium’s current nomenclature and reimbursement system will be revised in 2015 and a legal framework will be put in place so that telemonitoring, medical apps, and wearable medical technologies can be used and reimbursed in the near future.

Main Competitors

Belgium has approximately 800 companies manufacturing or distributing medical products. The majority of these firms are small or medium-sized, employing an average of 20 to 50 people. Belgian suppliers do well in niche markets, including anaesthesia equipment, diagnostic imaging, cancer diagnosis, and teleradiology.

Belgium is home to many subsidiaries of American companies such as GE Medical Systems, 3M, Abbott Vascular, Baxter, Johnson & Johnson Medical, Medtronic, Becton Dickinson, Boston Scientific.


Current Demand

Best prospects:

  • Innovative technologies
  • Minimally invasive and non-invasive equipment
  • User friendly homecare products
  • e-Health
  • Orthopedic and implantable products
  • Diabetes products.

Furthermore, there is a trend towards treating chronic diseases with new technologies allowing patients to stay home and minimizing the impact on their quality of life.

Barriers

There are no significant trade barriers on American medical devices.


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/

From 2014 some implantable medical devices will have to be registered from bringing the product on the Belgian market 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 marking must be accompanied by a four-figure number indicating the notified body. www.export.gov/cemark


Trade Events

 

Healthcare

Brussels, October 2016

Trade show for home healthcare products.
http://www.health-care.be/

U.S. Commercial Service Contact Information

Name: Danny Dumon
Position:
Commercial Specialist
Email:
danny.dumon@trade.gov
Phone
: +32 2 811 54 76


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