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Health and medical to Germany

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(Last updated: 26 Sep 2011)

Trends and opportunities

The market

Germany is the third largest medical device market in the world, ranking behind the USA and Japan. In 2010, the German medical device market was estimated at €14.7 billion, equal to €181 per capita. Nearly every German citizen benefits from health insurance. About 90 per cent are covered by one of the public insurance providers, while about nine per cent choose a private system. The challenges of an ageing society are met by new subsector products such as generics and health management – these sectors are also fostered by the health reforms recently passed by the German government.

Although in decline, the population of Germany still accounts for around 20 per cent of the total population of Western Europe with an estimated 81.6 million inhabitants in 2011.

At over 11 per cent of GDP, healthcare expenditure is at a high level but is increasingly constrained. The domestic market remains tight, with continued downward pressure on prices. Government funding of hospitals in recent years has remained static, therefore hospitals in the public sector are maintaining existing equipment rather than investing in new appliances. This has led to domestic producers becoming increasingly reliant on the export market.

Germany has a history of producing high quality medical equipment, with particular emphasis on diagnostic imaging, dental products and optical technologies. The country has a handful of large producers, headed by Siemens, B. Braun and Fresenius. Total production is estimated to be in the region of €20 billion, an increase of 8.9 per cent compared to 2009 (€18.3 billion).

Despite a strong domestic manufacturing industry, imports, which totalled €10.4 billion in 2009, supply around three-quarters of the medical market. Today, the German medical technology (med-tech) industry employs more than 170,000 people in more than 11,000 companies. The industry is dominated by medium-sized companies with 95 per cent of them employing less than 250 people. The sector ranks second behind the US in terms of market share in registered patents and generated a total of €18.3 billion in 2009. The broad spectrum of technologies available in this area ranges from electrical engineering/ electronics to precision mechanics and optics. Moreover, technologies from the textile industry, the plastics processing, pharmaceutical and, most recently, from the biotechnology industry are also utilised in German medical products.

Opportunities 

Germany is the largest market for medical devices in Europe and the third-largest in the world. The med-tech industry is considered to have the highest growth potential. According to a survey carried out by the German Federal Ministry of Education and Research in 2008, there will be an increasing demand for products and solutions in the following areas: 

  • Imaging systems
  • Prostheses and implants
  • Telemedicine and model-based therapy
  • Operational and interventional devices and systems
  • In-vitro diagnostics
  • Device and system networking

Based on cost cutting measures from the government, the med-tech industry must be prepared to define new target groups and additional sales channels beyond health insurance reimbursement.  

Competitive environment

Australia's main competitors in commodity products (such as single use syringes and other cheap products made from plastic) are low labour-cost countries in Southern Europe and Asia. In technology intensive product areas, leading sources of import to Germany in the medical devices/technology sector are the US, Japan and other countries from within the European Union (EU).

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Tariffs, regulations and customs

Industry standards

The EU has a harmonised trade system. Common Customs Tariff (CCT) is applicable to goods from non-EU countries, including Australia. Most duties are ad valorem (per cent), based on the GATT Valuation Code (approximate CIF value).

Before shipping any goods to Europe, you should obtain a written customs duty ruling from the local customs service. These rulings are called Binding Tariff Information (BTI). Getting a BTI is free and will prevent any conflict over customs or excise duty.

Import duty ranges from 6.9 per cent to 13.8 per cent depending on the type of product. An import turnover tax, similar to the Value Added Tax levied on domestically produced goods, of 19 per cent applies.

For further information on import duties please visit http://ec.europa.eu/taxation_customs/dds/tarhome_en.htm

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Marketing your products and services

Market entry

Foreign manufacturers of medical devices tend to enter the German market by setting up subsidiaries. It is also possible to enter the market by contracting with a specialised importer/wholesaler or distributor in the medical device field or by participating in the tender procedures of hospitals or clinics. Another way of finding business partners in Germany is by participating in specialised trade fairs.

All medical devices intended for the German market must bear a CE marking before they can be sold or installed. The CE marking is a mandatory conformity mark attached to certain products intended for sale within the EU, which indicates conformity with the essential health and safety requirements set out in the applicable European directives.

Depending on the type of product, conformity can be assessed either by the manufacturer himself or by an authorised office.

Foreign exporters must be aware that, in order to place medical devices on the market for the first time, the products must be registered with the appropriate competent authorities. In general, the manufacturer or authorised representative is responsible for the introduction of new medical devices on the market. The medical device importer is responsible in cases where the manufacturer's location is outside the EU and an authorised representative in the EU has not been designated.

The Federal Institute for Drugs and Medical Devices (BfArM) offers detailed information on the EU directives on medical devices as well as guidance in accessing the German medical device market and the prerequisites to be fulfilled. Furthermore, a list of notified bodies can be found on the German Institute of Medical Documentation and Information's website (DIMDI).

Manufacturers and importers of medical products must also make sure that their products comply with the Registration, Evaluation and Authorization of Chemicals regulations (REACH).  According to REACH, companies are required to prepare information on the chemical substances used in their products and register the data with the European Chemicals Agency (ECHA). Registration is required for most hazardous substances above one tonne per year, for substances toxic to the aquatic environment above 100 tonnes per year, or substances manufactured or imported above 1,000 tonnes per year. For many medical products compliance with REACH is a prerequisite for affixing the CE marking.

Major trade shows in Germany
Rehacare International – 21-24 September 2011, Düsseldorf 
International trade and congress for rehabilitation and care 
www.rehacare.com

Medica (Weltforum der Medizin) – 16-19 November 2011, Düsseldorf 
International trade fair and congress (including Compamed – international trade for hi-tech solutions for medical technology)
www.medica-tradefair.com

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Links and industry contacts

Association for Diagnostics Technology (German only) – www.vdgh.de/home.html
European Medical Industry Trade Representation – www.eucomed.org/
Federal Institute for Drugs and Medical Devices – www.bfarm.de/cln_103/EN/medDev/marketAcc/marketacc-node-en.html  
Federal Ministry of Health – www.bmg.bund.de/nn_1493790/EN/Ministerium/ministry__node.html?__nnn=true
German Association of Biomedical Engineering – www.vde.com/en/Technical Societies/Pages/DGBMT.aspx
German Electrical and Electronic Manufacturers' Association – www.zvei.de/index.php?id=552
German Industry Association for Optical, Medical and Mechatronical Technologies –
German Institute of Medical Documentation and Information – www.dimdi.de/static/en/index.html
German Medical Technology Association – www.bvmed.de/Start/?language=2
Hospimed International Database (German only) – www.hospimed.de/start.html
www.spectaris.de/english/index.htm
Medical Dealers Association (German only) – www.zmt.de/

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Contact details

The Australian Trade Commission – Austrade – is the Australian Government’s trade and investment development agency.

Through Austrade’s network of offices in over 50 countries, we assist Australian companies to succeed in international business, attract productive foreign direct investment into Australia and promote Australia's education sector internationally.

For more information on how Austrade can assist you, contact us on:

Australia ph: 13 28 78 | Email: info@austrade.gov.au

A list of Austrade offices (in alphabetical order of country) is also available.

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