U.S. DEPARTMENT OF COMMERCE

Medical Device Policy Mission to
Taiwan and South Korea

(October 24 – 28, 2005)

Description

The U.S. Department of Commerce’s International Trade Administration - Office of Health and Consumer Goods and U.S. Commercial Service are conducting a Policy Mission for medical device firms to Taiwan and South Korea October 24 - 28, 2005 that will be led by Albert A. Frink, Assistant Secretary for Manufacturing and Services.

The objective of the Mission is to create a more transparent trade environment for U.S. medical device export sales by facilitating U.S. industry interaction with officials in Taiwan and South Korea who develop and implement policies concerning the importation, regulatory approval, pricing/reimbursement levels, and marketing of products in the health technology sector.

The Mission is open to representatives of U.S. companies and trade associations in the medical device sector.

Commercial Setting:

Taiwan

Taiwan’s economy is ranked among the 20 largest in the world. Taiwan’s economic forecasts are bright with local predictions conservatively estimating growth at over five percent in the near term. Taiwan’s increasingly affluent population is spending a considerable amount of its income on health care. 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.

Although there is strong demand in Taiwan for high technology medical devices, U.S. firms face difficulties with Taiwan’s complicated regulatory system. Regulatory concerns include the need to provide large amounts of sensitive data to regulators, re-registration requirements, and limits on the number of products that a company can register in a given year. U.S. firms also face difficulties in getting their products reimbursed at rates that adequately reflect the value of the technology utilized in their products.

South Korea

South Korea is an economic leader in East Asia, with sustained growth since the 1998 Asian currency crisis. Bolstering the economic growth is Korea’s per capita income that recently ranked second, behind Japan throughout Asia. South Korea is one of Asia’s largest markets for medical devices, with a market of $1.4 billion in 2004. Approximately 28 percent of South Korea’s imports of medical devices come from the United States.

Market demand for advanced and innovative medical devices 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. However, U.S. firms face difficulties accessing this potential market due to South Korea’s difficult regulatory environment and reductions in the reimbursement rates for certain medical devices.

Mission Goals

The objective of the Mission is to create a more transparent trade environment for U.S. medical device export sales by facilitating the ability of U.S. industry to raise issues of concern with officials in Taiwan and South Korea. This includes providing input on recently issued medical device regulations and the establishment of pricing/reimbursement levels for both Taiwan and South Korea. This Mission will work toward this goal by establishing lines of communication between Department of Commerce, representatives of U.S. industry and the South Korean and Taiwanese officials who play a central role in developing and implementing policies governing the importation, regulatory approval, pricing, and marketing of products in the health technology sector. Improved interaction between U.S. industry and officials in Taiwan and South Korea will lay the groundwork for greater transparency in the regulatory and marketing environment and improve the ability of U.S. exporters to successfully sell their products in these two markets.

Mission Scenario

The medical device Policy Mission will take place over a five-day period of meetings in Taipei and Seoul. The U.S. Commercial Service will provide market briefings and schedule appointments with appropriate government officials involved with health technologies. Among the entities that will be invited to participate in meetings with the U.S. delegation are:

A. Taiwan Department of Health, Bureau of National Health Insurance, and the American Chamber of Commerce.

B. South Korean Food and Drug Administration, Ministry of Health and Welfare, Korean National Assembly’s Health & Welfare Committee, Korean Medical Device Industry Association, and American Chamber of Commerce in Seoul.

Most meetings will be group meetings led by Department of Commerce officials with opportunities for U.S. firms and industry associations participating in the meetings to provide input.

Timetable

Recruitment will begin in July 2005 and should be concluded no later than the end of August 2005. Applications received after that date will be considered only if space and scheduling constraints permit. A tentative schedule for the Policy Mission is attached.

The Policy Mission is tentatively scheduled to commence in Taipei, Taiwan and then travel to Seoul, South Korea. The precise schedule will depend on the availability of government and business officials, specific goals of Mission participants, and air travel schedules.

Participation Fees

The participation fee will be $2,200 per company or association, with a limit of one representative per firm or industry association. The participation fee does not include travel and lodging costs.

Criteria for Participation and Selection

• Relevance of a company’s business line to mission goals.
• Timeliness of company’s signed application and participation agreement (including a participation fee of $2,200).
• Potential for the company to do business in Taiwan and South Korea for.
• Minimum of six and maximum of eight participating companies in the mission (not including U.S. government officials).
• Certification that the company meets Departmental guidelines for participation. A company’s products or services must be either produced in the United States, or, if not, marketed under the name of a U.S. firm and have at least 51 percent U.S. content of the value of the finished product or service.

Any partisan political activities (including political contributions) of an applicant are entirely irrelevant to the selection process. Mission recruitment will be conducted in an open and public manner, including publication in the Federal Register, posting on the Commerce Department trade mission calendar - www.ita.doc.gov/doctm/tmcal.html - and other Internet web sites, press releases to the general and trade media, direct mail and broadcast fax, notices by industry trade associations and other multiplier groups, and at industry meetings, symposia, conferences, trade shows.

U.S. Contact Information:

Jay Biggs
U.S. Department of Commerce
Office of Health
and Consumer Goods
(202) 482 – 4431
jay_biggs@ita.doc.gov

Tentative Taiwan – South Korea Medical Device Policy Mission Schedule