Taiwan - Country Commercial Guide
Medical Devices

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-09-13

Overview

Taiwan is a major market for United States medical device exports. It is estimated that in 2020, Taiwan’s medical device market grew to approximately US$4.3 billion. Business Monitor International expects that the Taiwan medical device market will continue to grow by 6.6 percent annually over the next five years, as growing elderly population and the Taiwan authorities’ ongoing commitment to increase higher-value manufacturing; and greater adoption of innovative medical devices drives demands.  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 32 percent market share.

One of Taiwan’s major goals in the next few years is the development of its digital healthcare sector, especially in the telemedicine area to provide healthcare support in remote areas. During the COVID-19 pandemic, healthcare service was extended to some people in remote regions. Recognizing opportunities for efficiencies, the Taiwan Authorities are considering how to encourage the long-term development of telemedicine; in addition, how to address outdated regulations governing advanced medical devices. Major Taiwan hospitals are working with ICT companies to improve care through digitization. There may be opportunities for U.S. companies that provide innovative solutions in smart medical care, big data health services, AI and blockchain. Opportunities for digital healthcare may grow not only in the domestic market, but also due to Taiwan’s critical role in the global ICT supply chain.

Import of Medical Devices

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

 

2018

2019

2020 (est.)

2021 (est.)

Total Local Production

$3,658,058

$4,008,635

$4,346,666     

$4,520,532     

Total Exports

$2,242,562

$2,410,754

$2,591,560

$2,695,222

Total Imports

$2,526,969

$2,676,060

$2,833,947

$2,947,304

Imports from the U.S.

$819,418

$867,764

$918,962

$955,720

Total Market Size

$3,942,465

$4,273,941

$4,589,053

$4,772,614

Exchange Rate:  USD1

30.59

30.11

30.11

27.89


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

  • Computed tomography apparatus
  • Ultrasonic scanning apparatus
  • Ozone therapy, oxygen therapy, aerosol therapy, artificial resp
  • Magnetic resonance imaging apparatus
  • Ophthalmic instruments and appliances
  • Artificial joints
  • Cardiovascular equipment
  • Catheters
  • Chromatographs and electrophoresis instruments
  • Endoscopes
  • Hemodialysis apparatus
  • Prepared diagnostic and laboratory reagents
  • Shock wave lithotripsy apparatus
  • X-rays apparatus for dental uses

Opportunities

Population demographics in Taiwan present opportunities for healthcare companies. Approximately 14.6 percent of Taiwan’s 23.59 million population was over the age of 65 in 2019. 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.

Trade Shows

  • Bio Asia Taiwan 2021
  • Medical Taiwan 2021, Taipei
  • Healthcare+ Expo Taiwan, Taipei

Relevant Authorities

  • Customs Administration, Taiwan Ministry of Finance (MOF)
  • Taiwan Food and Drug Administration (TFDA)
  • Taiwan Ministry of Economic Affairs (MOEA)
  • Taiwan Ministry of Health and Welfare (MOHW)
  • Taiwan National Health Insurance Administration (NHIA)
  • Business Monitor International (BMI) Research
  • U.S. Census Bureau

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.