This is a best prospect industry sector for this country. Includes a market overview and trade data.
Last Published: 10/10/2018
With a population growth rate of 0.25%, approximately, 13% of Taiwan’s population in 2015 was over the age of 65, double the present over 65 in 1984. This trend is expected to continue. A recent MOHW report stated that in 2016, Taiwan National Health Expenditure (NHE) amounted to US$ 33.6 billion, representing 6.3% of GDP. The NHE is expected to grow annually at a rate of 4.7%, putting further strain on healthcare expenditures. This trend, however, is not merely driven by an aging population, but also by the slowing rate of economic growth, a universal healthcare coverage system and an increasing prevalence of chronic disease. About 62% of Taiwan’s healthcare expenditures are funded by the public sector, with the remaining 38% covered by out-of-pocket private spending. Taiwan has one of the highest per capita healthcare spending globally.
In 1995, Taiwan launched the National Health Insurance (NHI) program and has since that time provided high standard universal health coverage to 99.9% of the population through a single payer system. Taiwan is home to more than 20,000 primary and 500 secondary care units, many of which are small, privately owned clinics. Approximately 93% of all health care facilities are funded by the National Health Insurance (NHI) system. Beginning in 2013, Taiwan’s NHI entered its second-generation phase, which focuses on applying internet, cloud, and other information technologies to the system to optimize use and efficiency.
Many of the more advanced medical devices are too expensive for the NHI system. In these cases, a self-pay system is utilized, especially for items such as coronary stents, artificial ceramic hip joints, artificial intraocular lenses, and metal-on-metal artificial hip joints.
Taiwan is a major market for U.S. medical device exports. In 2017, the medical device market in Taiwan was US$ 4.3 billion. Business Monitor International expects that the Taiwan medical device market will continue to grow by 9% from 2017-2022. Taiwan’s lucrative medical device market is ranked among the top 25 in the world in terms of value.
Taiwan manufacturers export most their products to foreign markets. These exports consist primarily of mid-to-low-end medical equipment and contracted manufacturing for multinationals. The opportunity for imports is at the high-end, where the United States and Japan have been the primary suppliers. Over 70% of the market is still supplied by imports, of which the U.S. holds 34.9%, of the market share.
Generally, the following documents are required by Taiwan authorities for medical devices shipments, regardless of content or method of shipping: commercial invoice, certificate of origin, packing list, pro forma invoice, bill of lading, and 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 the regulations set by the MOHW, companies that import medical devices to Taiwan must submit the 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 meet the following requirements:
- Must be labeled with the product name, license number, name, and address of the manufacturer printed in Chinese;
- Manufacturing date and expiration date (the dates do not need to be in Chinese);
- The Chinese product name cannot be in a smaller print than the foreign product name.
The regulatory body for medical devices is the Division of Medical Devices and Cosmetics under the Taiwan Food and Drug Administration (TFDA).
Medical Devices Market Size
Unit: USD thousands
|Total Market Size||3,532,369||3,881,718||4,313,113||4,664,952|
|Total Local Production||2,848,943||3,098,141||3,577,889||3,863,558|
|Imports from the U.S.||362,336||370,052||368,140||401,273|
1 USD to NTD
Total Market Size = Total Local Production + Total Imports – Total Exports
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
- Cardiovascular equipment
- Computerized tomography
- Ultrasonic scanning apparatus
- Magnetic resonance imaging apparatus
- Hemodialysis apparatus
- Chromatographs and electrophoresis instruments
- Shock wave lithotripsy apparatus
- X-rays apparatus for dental uses
- Artificial joints
- Prepared diagnostic and laboratory reagents
- Growing elderly population and increasing National Health Expenditure (NHE) funding;
- High import demand over high end market;
- Access to Asia market: As living standards rise, there is increased demand for medical care in Asia. Taiwan is within a transportation hub in East and South Eas Asia, which makes Taiwan an ideal location for entering emerging markets in Asia.
- Taiwan Ministry of Health and Welfare
- Taiwan Food and Drug Administration
- Taiwan National Health Insurance Administration
- Taiwan Ministry of Economic Affairs (MOEA)
- Customs Administration, Taiwan Ministry of Finance
- Business Monitor International (BMI) Research
U.S. firms wishing to learn more about Taiwan’s medical devices market, as well expanding U.S. export opportunities to Taiwan are encouraged to contact CS Taipei Specialist Evan Gao at email@example.com or visit export.gov/taiwan.
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.