Partners
Market potential of the single markets
USA
The US medical technology market is the largest in the world with an estimated market volume of CHF 90 billion in 2011. Per capita expenditure, at CHF 285, is the third highest in the world. Without taking the current healthcare reforms into consideration, the market is expected to grow an average of 4% a year over the next five years – and still higher growth is anticipated over the long term due to the increasing proportion of the population over 65 years of age and a steadily rising life expectancy. In general, no import restrictions exist for Swiss medical technology products; however, the complex American regulatory, reimbursement and judicial systems can be a major obstacle. The increasingly complicated requirements of the Food and Drug Administration (FDA), which regulates medical products make it essential for companies to familiarize themselves with the federal regulations and requirements in order to avoid lengthy delays in entering the market and ensure reimbursement coverage. Additionally, US product liability law is complicated and Swiss companies should exercise great care to protect against expensive lawsuits.
>> upcoming events on the US market
>> senior advisor USA
>> available Reports
France
With a market volume of about CHF 9.7 billion in 2009, the French market is the second largest in Europe. An annual growth rate of 5.5% is forecasted through 2015. In general, agreements between Switzerland and the EU mean that Swiss exports to France do not face any additional regulatory costs, and therefore should not incur any additional administrative expenses. The CE mark intended to ensure that a product conforms to the essential requirements of the applicable directives, is mandatory for medical technology products sold and distributed within the EU. The cost of CE certification depends upon the classification of the product: the Medical Devices Directive for general medical devices; the Active Implantable Medical Devices Directive for products intended for permanent implantation in humans; and the In Vitro Diagnostics Directive for devices used to diagnose a patient’s medical condition. G-Med, the French counterpart to the Swiss certification authority Swissmedic, is responsible for certifications in the area of health and medical technology.
>> upcoming events on the French market
>> available Reports
China
China’s volume of CHF 10.9 billion makes it the world’s fourth largest medical technology market. It is forecasted to grow at an annual rate of more than 11% through 2014 due to huge population and economic growth. Although China depends heavily on imports, market access is complex: products must be registered with several different authorities, and cost varies according to product category. The State Food and Drug Administration, the Chinese regulatory authority, requires a significant amount of information to obtain an Import Medical Device Registration Certificate, including a Registration Standard document that must be submitted with product samples for testing. Manufacturers of some higher risk devices may need to submit clinical data generated in China. Companies must also appoint a Legal Agent (LA) and After Sales Agent. While distributors may fulfill the LA role, this severely limits a company’s flexibility to switch distributors since the LA also controls the company’s device approval. Hiring an independent LA provides more control over distribution. Compliance with the quality system requirements of the US FDA, Europe or Canada will be accepted in China. Import certificates are valid for 4 years.
>> upcoming events on the Chinese market
>> senior advisor China
>> available Reports
Germany
Germany, third largest market for medical technology products behind the USA and Japan, had a market volume of CHF 16.5 billion in 2010, and a per capita spend of CHF 200. At over 11% of GDP, healthcare expenditure is at a high level but is increasingly constrained. The domestic market remains tight, with continued downward pressure on prices. Based on agreements with the EU, Swiss exports to Germany are not subject to any duties or other taxes, except for the deduction of value-added tax (VAT). No additional administrative or regulatory requirements must be met. Like France, Germany recently enacted EU guidelines into national law; requiring national registration and CE certification before marketing medical technology. The CE mark, intended to ensure that products conform to essential requirements of the applicable directives, is mandatory for medical products sold and distributed within the EU. The cost of CE certification depends upon the classification of the product: the Medical Devices Directive for general medical devices; the Active Implantable Medical Devices Directive for permanent implants; and the In Vitro Diagnostics Directive for diagnostic products.
>> upcoming events on the German market
>> available Reports
Japan
With a market volume of CHF 21.9 billion in 2009, Japan is the world’s second largest market for medical technology products. A relatively low average growth rate of about 1.5% is expected in the short term; however some sectors , such as therapeutic devices, are projected to experience robust growth.. Although the Japanese government imposes no import duties on medical devices, legal regulations make access to this large market difficult. Bringing a medical device to market requires regulatory approval from the Ministry of Health, Labor and Welfare, and a manufacturing license specific to the facility where the device is produced. The approval must be held by a Market Authorization Holder, the entity that will actually bring the product to market in Japan. Depending upon the product, additional licenses may be required. The licensing procedure is complicated and takes considerably longer than in other countries; products are typically launched in Japan two to three years after debuting in Europe or the USA. The multistage distribution process adds additional cost and complexity, making entry into the Japanese market challenging.
>> upcoming events on the Japanese market
>> available Reports
India
India ranks among the world’s top 20 medical device markets with a current value of CHF 715 million, or slightly more than 1% of the nation’s $66 billion healthcare industry. Growth is projected to be 17% through 2016 when it reaches CHF 1.7 billion. Despite strong growth, the market remains disproportionately small with per capita spending of just CHF 2. The Indian market is largely unregulated and most medical devices can be freely imported. However certain device classes were regulated under the recently enacted Drugs and Cosmetics Rules and must now be registered. The regulating authority is the Central Drug Standard Control Organization in the Ministry of Health. Comprehensive legislation is pending and expected to go into effect for some classes of medical devices in 2011 or 2012. The procedure will only be clear after final regulations and import guidelines are published. Currently, manufacturers of medical devices requiring registration can leverage approvals from the US, Canada, Europe, Australia or Japan to register their products in India. It takes approximately 6-9 months to complete the process and once granted, registrations are valid for 3 years.
>> upcoming events on the Indian market
Russian Federation
The Russian medtech market is potentially huge, however health expenditures remain low and patients must often pay for treatment themselves. A medical insurance system is in place, but is ineffectual and quality varies widely. The healthcare structure tends to be bureaucratic and inefficient. Recently the government enacted a national ‘health’ project to improve standards. In 2011, the Russian market for medical technology is estimated at CHF 5 billion. Per capita spending is low by European standards at CHF 35 per capita. The main agency overseeing medical devices is the Department of Registration of Foreign Medical Equipment and Devices. Foreign companies are required to have a local “authorized representative” to communicate with authorities and register their products. Many companies appoint their distributor however this may give the distributor control over the device registration so care should be taken in selecting an independent representative. The Russian approval process is based on product testing, regardless of whether a product has been tested and certified to international standards. Russia does not recognize approvals from any other national government, however, it MAY require a device to have approval in its home market.
>> upcoming events on the Russian market
>> available Reports
Brazil
Brazil has the largest economy and medical device market in Latin America, but per capita medical expenditure is still very low. The Brazilian market was estimated at CHF 3.8 billion in 2010 with projected growth of more than 10%. Medical devices are regulated by the Agência Nacional de Vigilância Sanitária (ANVISA) and the regulations and classification schemes are similar to those found in Europe. Companies without a local establishment are required to appoint a Brazilian Registration Holder as a liaison with ANVISA. Once the Brazil Registration Holder role is appointed, it controls the registration for your products and cannot be transferred. A Technical File (TF) must be submitted for each product proving it is safe and effective. The Brazilian TF differs from European or FDA applications; however companies whose products already have CE Marking or FDA clearance will have conducted testing that satisfies most of the ANVISA registration requirements. The process of getting a Class I, II or III medical device approved typically ranges from 6-12 months. Good Manufacturing Practices, similar to those in the USA, must also be met, and biennial audits are conducted.
>> upcoming events on the Brazilian market
>> available Reports
Taiwan
Taiwan is among the top 25 medical device markets in the world with a value of CHF 190 in 2009 and projected growth of 7.3% through 2014. Over 75% of the market is supplied through imports. One of the richest countries in Asia, Taiwan has a strong healthcare system and universal health insurance; however it is constrained by rising costs and an aging population. Medical devices are regulated by the Department of Health (DOH) and required to obtain premarket registration before they can be manufactured locally or imported. Since DOH issues licenses only to locally based firms, all foreign suppliers must have a Taiwan importer or registered subsidiary. To market a medical device the registration approval must be obtained before an import license will be issued. Taiwan is harmonizing domestic medical device classifications with the commonly used international classification systems. All medical devices must now meet the Good Manufacturing Practice Requirements which are based on ISO 13485. In general, the number of days for GMP and registration approval is 90-120 days. Local clinical trials are required for certain categories of devices as specified by DOH’s Medical Reviewing Board.
>> upcoming events on the Taiwanese market
United Arab Emirates
The UAE market for medical devices was estimated at CHF 600 million in 2010 and projected to average 13.2% growth through 2015 to CHF 1.1 billion. Healthcare spending, estimated at CHF 8 billion, represents only 3.3% of GDP, however per capita spending is among the top 20 in the world at CHF1420. Imports account for approximately 94.8% of the market and growth is expected to remain strong due to the country’s limited domestic production capability. The main authorities regulating healthcare are the Ministry of Health (MOH), the Health Authority-Abu Dhabi, the Dubai Health Authority, and the Emirates Health Authority. Medical devices are supervised by the Drug Control Department (DCD) of the MOH and subject to Medical Devices Registration Guidelines. The UAE regulatory process is similar to systems from the EU, USA, and Australia. Manufacturers must register with the MOH before marketing their products. Companies wanting to import products must do so via a local, licensed representative or distributor. The appointed representative or distributor must submit a registration application to the DCD, which if approved, is valid for five years. The approval process is estimated to take 8-12 weeks.
>> upcoming events on the U.A.E. market
Switzerland
Switzerland is among the global hotspots for medical technology with over 1,400 companies currently active in the sector. Accounting for about 2% of the Swiss GDP, the medical technologies field has become a pillar of the Swiss economy and currently employs about 1.4% of the Swiss workforce. The Swiss medical technologies industry consist of about 730 suppliers and manufacturers as well as about 650 traders, distributers, and service providers.
Contributing to the success of the Swiss medical technologies field is the wide diversity of specializations and products. Currently Switzerland houses about 10,000 different product families. Implantable technologies compose the majority of products, followed by products for orthopedics, trauma, and dentistry. Due to a focus on precision, quality and innovation, Swiss medtech companies have established a stable position in the global market for medical technologies.
Swiss medical technology industry (SMTI) suppliers and service providers also contribute to the overall success of the industry. The SMTI supplier base is broadly specialized with more than 55% of suppliers concentrating on various components, systems, and materials processing. Additionally Swiss service providers offer services and expertise to businesses across the globe with IT services dominating this sector, followed by providers of management consulting, engineering, and planning and design.
The Swiss medical technologies sector covers the entire value chain from research and development to manufacturing and product distribution. With a commitment to excellence and innovation, the SMTI provides the global medtech market with new technologies and opportunities for profitable collaborations.
>> Search for Swiss medtech companies
>> upcoming events
>> available Reports
Canada
The Canadian medical device market was estimated at $6.2B in 2009 and is primarily an import market with 52% of all imports destined for the US. Geographically, the medical device industry is concentrated in the provinces of Ontario, Quebec and British Colombia with over 80% of the industry located in Ontario and Quebec. The health care industry in Canada has experienced steady growth in the past decade, driven by universal access to health care, an aging population, and advances in pharmaceutical and medical technologies. The best represented technology markets in Canada are disposable equipment and supplies (including in vitro diagnostics), electro-medical devices, and medical imaging equipment and supplies. In terms of therapeutic applications, the largest market segments are cardiovascular and dental devices, both predominantly import-dependent markets. Due to its location, Canada acts as a great entry point for medical parts and materials suppliers for local manufacturers selling into the US market.
>> upcoming events on the Canadian market
>> available Reports