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: 2020-09-25

Overview

In 2019, Taiwan’s medical device market grew to approximately $ 4.2 billion.  Business Monitor International expects that the Taiwan medical device market will continue to grow by 7 percent annually over the next five years, as Taiwan’s aging drives demands.   Taiwan manufacturers primarily produce mid-to-low-end medical equipment, mostly through contract manufacturing for multinationals.  High-end medical devices present the greatest opportunity for exports to the Taiwan market: over 70 percent of Taiwan’s market is still supplied by imports, of which the United States holds approximately a 32 percent market share.

As the sixth largest medical device market in the Asia Pacific region, according to BMI Research, Taiwan’s medical device market opportunities are reinforced by its above average spending per capita and robust market growth.  Taiwan has one of the world’s best healthcare system which facilitates patient access to affordable and high-quality medical services.

The January 15, 2020 Medical Device Management Act is a positive step in creating a dedicated regulatory system for medical devices in Taiwan.  Industry believes the Act will help create a pathway for innovative medical devices more rapidly entering the Taiwan market.

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.  Additionally, the Chinese product name cannot be in smaller print than the foreign product name.

Medical Devices Market                                                                   Unit: USD thousands

 

2017

2018

2019 (est.)

2020 (est.)

Total Local Production

$3,487,342

$3,658,058

$4,008,635

$4,346,666      

Total Exports

$2,097,689

$2,242,562

$2,410,754

$2,591,560

Total Imports

$2,445,193

$2,526,969

$2,676,060

$2,833,947

Imports from the U.S.

$804,991

$819,418

$867,764

$918,962

Total Market Size

$3,834,846

$3,942,465

$4,273,941

$4,589,053

Exchange Rate:  USD1

29.65

30.59

30.11

30.28

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.  According to the Taiwan’s Ministry of the Interior, by 2026, Taiwan will become a “super-aged” society with more than 20% population over age 65.  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 very costly and will result in cost constraints for the NHI system.  Therefore, NHI and industry are discussing the expansion of the self-pay and balance billing (partial patient self-pay mechanism) categories, especially for items such as coronary stents, artificial ceramic hip joints, artificial intraocular lenses and metal-on-metal artificial hip joints.

The promulgation of the Medical Device Act brings implementation of a dedicated regulatory system for medical devices a step closer.  The Act will deregulate some low risk devices by allowing them to be exempt from premarket review, it will also introduce a fast-track approval process for innovative devices that fulfills unmet clinical needs, which will stimulate innovation in the medtech sector.

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.