Overview 

Taiwan is a major market for United States medical device exports. According to the 2022 Taiwan Biotechnology Industry Report published by the Taiwan Ministry of Economic Affairs (MOEA), Taiwan’s medical devices industry was valued at around 6.4 billion in 2021, a 22 percent increase over 2020, mainly as a result of official policies to support innovation and the demand created by the COVID pandemic. Also, Taiwan’s elderly population and region-leading healthcare systems make Taiwan an attractive market for U.S. medical device companies. Industry expects that the Taiwan medical device market will continue to grow by around 7 percent annually over the next five years, as a growing elderly population and the Taiwan authorities’ ongoing commitment to increase higher-value manufacturing; and greater adoption of innovative medical devices drives demands.

Despite the implementation of innovation incentive policies for domestic producers of priority technologies, it is likely that Taiwan’s medical device sector will continue to rely on imported devices. Taiwan manufacturers primarily manufacture and 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. The U.S. is still the largest import country, taking up 30 percent of the market share in most product areas such as orthopedics, diagnostic imaging, dental products and consumables. Other major importers include China, Germany, Japan, and other EU countries.      

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 to remote areas. During the COVID-19 pandemic, healthcare service was extended to some people in remote regions. To this end, the Taiwan authorities are interested in encouraging the long-term development of telemedicine.  This will require addressing Taiwan’s outdated regulations governing advanced medical devices.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). Class II and III 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. 

Unit: USD thousands

*Total Taiwan Medical Devices Market Size = (Total Local Production + Total Imports) – (Total Exports)

Sources: Taiwan Ministry of Economic Affairs

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 

Taiwan’s changing population demographics point to opportunities for U.S. healthcare companies. Approximately 24 percent of Taiwan’s 23.37 million population was over the age of 60 in 2022. Ministry of Health and Welfare (MOHW) reports indicate that the proportion of senior population will continue to grow, underscoring the importance of affordable, long-term care. In response to these trends, sustained growth in Taiwan’s National Health Insurance (NHI) budget and expenditures is also projected.

With increasing demand for high-end medical device imports, the importance of Taiwan’s 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.

Trade Shows 

• Bio Asia Taiwan 2023 (https://expo.bioasiataiwan.com/en/) 
• Medical Taiwan 2024 (https://www.medicaltaiwan.com.tw) 
• Healthcare+ Expo Taiwan 2023 (https://expo.taiwan-healthcare.org/en/) 

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