Healthcare Technologies Resource Guide - Export.gov

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8 The Austrian market for medical equipment is sophisticated and well-served. Industry giants such as Siemens, Philips, Hitachi, and Toshiba are well entrenched. General Electric GmbH, Agilent Technologies Oesterreich GmbH, Nova Biomedical GesmbH, and Tyco Healthcare Austria GmbH are only a few of the Austrian subsidiaries of U.S. medical device suppliers. Against the heavy German competition in this market, American products can usually compete well on the basis of price and innovation. Current Demand The following high-quality products and devices are currently in demand in Austria: • Nuclear medical instruments (nuclear magnetic resonance scanners) • Diagnostic apparatus including cardiology instruments, echocardiography systems, advanced electrocardiograph equipment, monitoring systems,ultrasound equipment, gynecology and urology diagnostic systems, and endoscopes • Scanners, computer tomography imaging systems, magnetic resonance imaging • Dialysis equipment • Pacemakers • Sophisticated digitalized x-ray equipment • Clinical laboratory equipment including blood cell counters, and blood gas analyzers • In-vitro diagnostic products The trend is moving toward miniaturization of electro-medical devices and nano-technology products. Registration Process All U.S. medical devices have to be marked with the mandatory CE (Conformité Européenne) conformity mark. With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives. Deviating from sector directives regulating other industrial goods, medical devices have to comply with “essential requirements” as described in Annex I of Directive 93/42/EEC. According to this, medical devices must not only be safe but must also function in a medical-technical way as described in the manufacturer’s “intended purpose.” Compliance with these requirements is proved within a certified quality management system according to EN ISO 13485. Barriers Austria is a highly developed open market with relatively liberal policies and sharp competition. The import climate is favorable towards U.S. products. American exporters, like domestic and European firms, are subject to packaging and other collection, recycling, and reprocessing laws. There are no significant trade barriers or limitations on U.S. medical devices. Trade Events At the present time, there is no general medical fair planned in Austria. Some smaller specialized medical exhibitions are organized in connection with medical conventions. The great majority of Austrian medical importers/distributors regularly attend the most important European medical fair: MEDICA November 14–17, 2012; November 20–23, 2013; November 12–15, 2014 Messe Duesseldorf GmbH, Duesseldorf, Germany Considered the world’s most important and largest international fair for medical equipment, the annual MEDICA draws 134,000 trade visitors from 85 countries. Over 5,200 distributors from 65 foreign countries are able to exhibit with over 2.8 million square feet of space in 17 halls. Available Market Research • Austria—Dental Industry Market Brief 2011 • Austria—In-Vitro Diagnostics 2011 U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013
Belgium Summary Belgium produces less than 10 percent of its overall needs for medical equipment. This leaves the market open for heavy competition among suppliers from the U.S., Germany, France and Great Britain. The United States currently has a 20 percent share of total medical equipment imports into Belgium. In 2010, the Belgian market for medical equipment was estimated at $4.2 billion and employed 18,000 people. Belgium imported approx. $1.9 billion worth of medical equipment from the U.S. in 2010. Over the past 5 years, this sector has seen an annual growth of approximately 3 to 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 10.5 million inhabitants. In 2010, total healthcare expenditure was estimated at $28 billion. 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. The following EU directives were transposed into national law: • Directive 90/385/EEC on active implantable medical devices • Directive 93/42/EEC on medical devices • ec.europa.eu/health/medical-devices/regulatory-framework Current Market Trends Belgium’s healthcare system is currently facing several challenges. Belgium’s growing aging population and the higher health expectations will have an important impact on healthcare expenditures in the coming years. The GOB is therefore looking at various cost-saving measures. Thus, innovative technologies and equipment offering cost savings will have a strong market Statistics Capital: Brussels Population: 10,438,353 GDP: USD 418.6 billion (2011) Currency: Euro (€) Language: Dutch, French, German U.S. Commercial Service Healthcare Technologies Resource Guide | 2012–2013 Contact Danny Dumon Commercial Advisor danny.dumon@trade.gov +32 2 811 5476 9
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148 Certification Reference Chart E
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154 Vermont Susan Murray—Montpeli
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1208-05-17
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