This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 11/8/2019

Overview

Taiwan is a major market for United States medical device exports. In 2018, Taiwan’s medical device market grew to approximately $4.6 billion and was ranked among the top 25 globally in terms of value. Business Monitor International expects that the Taiwan medical device market will continue to grow by 7.8 percent annually over the next five years. Due to limited market size, Taiwan manufacturers primarily export mid-to-low-end medical equipment, mostly through contract manufacturing for multinationals.

High-end medical devices present the greatest opportunity for imports in the Taiwan market: over 70 percent of the market is still supplied by imports, of which the United States holds about a 34.9 percent market share.

Regardless of content or method of shipping, documentation for medical devices shipments must include a commercial invoice, certificate of origin, packing list, pro forma invoice, and bill of lading. Additionally, medical devices also require a Certificate of Free Sale. The Certificate of Free Sale for medical devices may be obtained from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

In Taiwan, medical devices must be registered with the Ministry of Health and Welfare (MOHW). Licenses are granted only to individual products and not to product lines. According to MOHW regulations, companies that import medical devices to Taiwan must submit required documentation through their Taiwan importers or Taiwan subsidiaries.

In Taiwan, medical devices are divided into three risk classification levels: Class I (low risk), Class II (medium-risk) and Class III (high-risk). The latter two medical devices sold in Taiwan must be labeled in Chinese with the product name; license number; name and address of the manufacturer; and, manufacturing date and/or expiration date (these need not be in Chinese). Additionally, the Chinese product name cannot be in smaller print than the foreign product name.

Medical Devices Market                                                                                                                 Unit: USD thousands
 2016201720182019 (est.)
Total Local Production$3,098,141$3,577,889$3,863,558$4,164,916
Total Exports$848,853$944,533$995,165$1,072,788
Total Imports$1,540,942$1,721,703$1,728,938$1,863,795
Imports from the U.S.$507,492$547,147$561,711$605,524
Total Market Size$3,790,230$4,355,059$4,597,331$4,955,923
Exchange Rate:  USD132.4029.6530.5930.86
Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
Sources: Total Local Production: Taiwan Ministry of Economic Affairs; Total Exports: Customs Administration, Taiwan Ministry of Finance; Total Imports: Customs Administration, Taiwan Ministry of Finance; Imports from U.S.: U.S. Census Bureau; Exchange rates: U.S. Treasury Department

Leading Sub-Sectors

  • Artificial joints
  • Cardiovascular equipment
  • Catheters
  • Chromatographs and electrophoresis instruments
  • Computerized tomography
  • Endoscopes
  • Hemodialysis apparatus
  • Magnetic resonance imaging apparatus
  • Prepared diagnostic and laboratory reagents
  • Shock wave lithotripsy apparatus
  • Ultrasonic scanning apparatus
  • X-rays apparatus for dental uses

Opportunities

Population demographics in Taiwan present opportunities for healthcare companies. Approximately 13.86 percent of Taiwan’s 23.62 million population was over the age of 65 in 2017. Ministry of Health and Welfare (MOHW) reports indicate that Taiwan’s population will continue to grow until the year 2021 as will the proportion of seniors, underscoring the importance of affordable, long-term care. National Health Insurance (NHI) expenditures are also projected to grow through this period and into the future.

With high demand for high-end medical device imports, the importance of Taiwan’s National Health Insurance (NHI) program will grow, as many of the more advanced medical devices are too expensive for the NHI system to reimburse their users. In such cases, a self-pay category is utilized, especially for items such as coronary stents, artificial ceramic hip joints, artificial intraocular lenses and metal-on-metal artificial hip joints.
As living standards rise throughout Asia, the demand for medical care will continue to rise. Taiwan is within the transportation hub of the Asia-Pacific region, making it an ideal location from which to enter the emerging markets of Asia, especially mainland China.

Web Resources

Trade Shows

Relevant Authorities

U.S. firms interested in learning more about the Medical Devices market and seeking to expand their export opportunities to Taiwan are encouraged to contact CS Taiwan Commercial Specialist Grace Tao at Grace.Tao@trade.gov or visit our website.

Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.