Mission Statement

U.S. Healthcare Technologies Trade Mission

Taiwan, Korea and The Philippines  

March 11-18, 2005

Mission Description:

The United States Department of Commerce, International Trade Administration, U.S. Commercial Service, Office of Global Trade Programs, is organizing a Healthcare Technologies Trade Mission to Taiwan and Korea, with an optional one-day stop in the Philippines, March 11-18, 2005.   The Trade Mission will target a broad range of sectors within the healthcare industry. The focus of the delegation will be to match participating U.S. companies with qualified agents, distributors, representatives, licensees, and joint venture partners in these markets, which all have a strong affinity for, and trading relationship with, the United States.

Commercial Setting:

Taiwan

The United States exported approximately USD 161 million of medical products to Taiwan in 2003.   

U.S. made medical products have an excellent reputation in Taiwan for high quality, advanced technology, and durability.   The major customers for U.S. products will continue to be public hospitals and large private clinics.   There are a total of 719 hospitals in Taiwan, of which 596 are public and 123 are privately owned.   Both the Department of Health and authorities at the local level control budgets for public hospitals and municipal hospitals.   The majority of the 17,012 clinics are privately operated.

There is strong demand in Taiwan for a number of medical products and services, including those related to orthopedics, rehabilitation, cardiology, and diagnostics, particularly pertaining to cancer detection. Additionally, due to increased male and female life expectancy in Taiwan, the demand for medical products for senior citizens continues to grow.  

Taiwan’s increasingly affluent population is spending a considerable amount of its income on healthcare.   Total consumption expenditures for medical care and related expenses have significantly expanded in recent years, fueled in part by the implementation of the National Health Insurance Program (NHIP), which covers 97 percent of Taiwan’s 23 million people.  

Taiwan is currently in the process of harmonizing domestic medical device classification with the commonly used international classification system. All medical devices will need to meet the Good Manufacturing Practice (GMP) requirement, based on ISO 13485.   In Taiwan, medical devices are regulated under the Pharmaceutical Affairs Law.     All medical devices, regardless of class, require pre-market approval.   If everything is in order, a license is usually granted within six months.   To market a medical device in Taiwan, the DOH’s pre-marketing registration approval must be obtained before the Board of Foreign Trade (BOFT) of the Ministry of Economic Affairs (MOEA) issues an import license.   A distributor in Taiwan can assist U.S. exporters with this process.

Taiwan’s economy is ranked among the 20 largest in the world.   The country holds the world’s third largest amount of foreign reserves, and in spite of recent challenges with SARS and political issues, Taiwan’s economy continues to grow steadily.   Taiwan’s economic forecasts are bright, with local predictions conservatively estimating growth at over five percent in the near term.   

Korea

Korea is one of the world’s largest markets for medical devices and pharmaceuticals.   The United States exported USD 227 million of medical products to the Korean market   in 2003.   There are approximately 1,000 hospitals and 20,000 clinics in Korea.  

A broad range of U.S. medical products have strong potential in Korea.   Market demand for advanced and innovative medical devices, including artificial joints, is expected to remain strong over the next several years as Korea's hospitals continue to purchase technology-intensive products from abroad, and as increasing numbers of elderly Korean patients require sophisticated medical procedures.

In compliance with World Trade Organization (WTO) obligations, the Korean Government plans to eliminate tariffs on medical products, in phases, providing an additional incentive for U.S. medical manufacturers to export their products to Korea.

All medical device products are required to obtain marketing clearance from the Korea Food & Drug Administration (KFDA) before they can be manufactured in, or imported into, Korea. To that end, a medical device follows one of two different regulatory pathways, depending on its classification under the Korean regulatory system. In particular, testing of Class II or III medical devices under the Korean classification system is mandatory before a product is approved and each time a shipment of the approved product is imported. However, there are general criteria under which imported devices may be exempt from local testing. Many U.S. firms may already have test reports conducted in the U.S., or elsewhere, which have been generated during the course of product development and can be used by a Korean partner to reduce time and costs of getting products to market.

Since the Asian economic crisis in 1997-1998, Korea has implemented important structural reforms aimed at transforming its economy into one that is less regulated and more market-driven.   Korea is an economic leader in East Asia, with sustained growth since the economic crisis.   Bolstering the economic growth is Korea’s per capita income, which recently ranked only behind Japan throughout Asia.

The Philippines (optional one-day stop)

Despite recent economic and political challenges in the Philippines, demand for medical products continues to grow. The medical market is almost 100% imported, as the Philippines does not manufacture medical or surgical equipment. About 50% of medical disposables are also imported.   The United States exported USD 12 million of medical products in 2003.   U.S. products are highly regarded in the Philippine market.   However, U.S. manufacturers face increasing competition from third-country suppliers.   Among best prospects for U.S. companies are radiology equipment, electro-medical equipment, diagnostics, surgical and optical instruments, and cardiology-related products.

While the Philippine economy faces challenges, it continues to support an excellent market for American exporters, posting recent GDP growth of 4.7 percent, and a low inflation rate of 3 per cent.    In 2003, the United States had exports of USD 7.99 billion to the Philippines, making it the U.S.’s 19th largest export market.  

Mission Goals:

The Trade Mission's goal is to provide market entry into the Taiwan, Korean and Philippine markets for new-to-market, and/or new-to-export U.S. healthcare firms, as well as first-hand market information and access to key government officials and potential business partners.

Mission Scenario:

The trade mission will commence with an optional one-day stop in Manila, the Philippines; spend two days in Taipei, Taiwan, and two days in Seoul, Korea.  

In Korea, the following services will be provided to mission participants at no additional cost:

• Company literature will be displayed as part of the U.S. Commercial Service booth at the Korea International Medical Equipment Show (KIMES), the largest medical products trade show in Korea.   The booth will be staffed by CS Seoul Commercial Specialists and the mission Project Officer, who will collect and forward leads to the U.S. companies for follow-up, and provide assistance with follow-up as needed.
• Note: This literature event will also be offered to non-mission participants for a $250 participation fee.   
• Trade mission participants will also visit KIMES on March 18, 2005, the final day of the mission to “walk” the trade show floor and meet with Korean (and possibly other) enterprises.   More than 750 companies from 30 countries exhibited at KIMES 2004, with Korean and United States companies comprising the largest and second largest contingents, respectively, of exhibitors.  

At each stop, the U.S. Commercial Service will:

• Provide a market briefing highlighting opportunities in the healthcare technologies sector;
• Schedule one-on-one appointments with potential business partners for each participant;
• Arrange hospitality events to introduce participants to key business and industry officials (with the exception of Manila, the optional one-day stop).

Tentative Timetable:

Criteria for Participation:

• Relevance of the company's business line to the mission scope and goals
• Potential for business in the selected markets
• Timeliness of the company's completed application, participation agreement, and payment of the mission participation fee
• Provision of adequate information on the company's products and/or services and communication of the company's primary objectives to facilitate appropriate matching with potential business partners
• Certification that the company's products and/or services are manufactured or produced in the United States or if manufactured/produced outside of the United States, the product/service must be marketed under the name of a U.S. firm and have U.S. content representing at least 51 percent of the value of the finished good or service.

The mission will be promoted through the following venues: Export Assistance Centers and the healthcare team; industry newsletters; the Federal Register; relevant trade publications; relevant trade associations; past Commerce trade mission participants; various in-house and purchased industry lists, and on the Commerce Department trade missions calendar:   www.ita.doc.gov/doctm/tmcal.html .

Any partisan political activities of an applicant, including political contributions, will be entirely irrelevant to the selection process. The trade mission participation fee will be USD 3,500 for Taiwan and Korea, and USD 500 for the optional one-day stop in Manila.   The participation fee does not include the cost of travel and lodging.   Participation is open to the first 10 qualified U.S. companies.   Recruitment will begin immediately and will close on January 31, 2005.   Applications received after that date will be considered only if space and scheduling constraints permit.

Contact Information:

Bill Kutson, Project Manager
U.S. Commercial Service
Global Trade Programs
U.S. Department of Commerce, Room 2012
Washington, D.C. 20230
Tel: (202) 482-2839
Fax: (202) 482-0178
E-mail: William.Kutson@mail.doc.gov