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Healthcare Resource Guide: Taiwan

Taiwan Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Barriers

Trade Events

CS Contacts

Best Prospects

Market Size

Capital: Taipei

Population: 23.55 million

GDP*: US$529.7 billion

Currency: New Taiwan dollar (TWD)

Language: Mandarin

Summary

                              

With a population of 23.55 million, Taiwan is a thriving democracy, a vibrant market economy, and a highly attractive export destination, especially for U.S. firms.

As of May 2017, Taiwan was ranked as the United States’ 10th largest trading partner in goods, placing it ahead of markets such as Italy and Brazil1. It was also the 14th largest U.S. export market overall.

As living standards rise in Asia, there is increased demand for medical care. A key point of access to the Asian healthcare market, Taiwan’s strategic location in the transportation hub of the Asia-Pacific region makes it an ideal location for entering emerging markets, especially in the case of China.

Since launching the National Health Insurance (NHI) program in 1995, Taiwan has provided universal health coverage (99.9% of the population) through a single payer system.

There are over 20,000 primary and 500 secondary care units in Taiwan, many of which are small, privately owned clinics. In 2016, approximately 93% of all health care facilities were contracted by the NHI system to provide healthcare service. Taiwan’s NHI entered its second-generation phase in 2013, 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 to reimburse 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.

Taiwan is a major market for U.S. medical device exports and is ranked among the top 25 in the world in terms of value. As of 2017, the medical device market in Taiwan has grown to approximately US$5.937 billion. Business Monitor International expects that the Taiwan medical device market will continue to grow by CAGR of 7.7% from 2014 to 2019. Due to its own limited market size, Taiwan manufacturers export most their products, which consist primarily of mid-to-low end medical equipment and contracted manufacturing for multinationals. Major opportunities for imports in Taiwan are at the high-end level, where the United States and Japan have been the primary players. Over 70% of this market is still supplied by imports, 34.9% of which are supplied by the U.S.

                                          

Market Entry

For any manufacturer wishing to enter Taiwan, it is essential to appoint a local distributor. Private hospitals in Taiwan tend to make deals on a one-to-one basis with local agents. Equipment tenders for public hospitals are handled through the Taiwan Authorities procurement agency. According to the Taiwan Ministry of Health and Welfare, there are 55,926 registered dealers for medical devices and pharmaceuticals in Taiwan. 

Current Market Trends

With a population growth rate of 0.25%, approximately 13% of Taiwan’s population in 2015 was over the age of 65. This percentage of senior population is more than double the percentage in 1984. Some would attribute this trend to the success of Taiwan’s health care system.

The Ministry of Health and Welfare (MOHW) reports that Taiwan’s population will continue to rise until the year 2021, along with an increase in the population of seniors. As a result, the National Health Expenditure (NHE) should continue to increase. In 20152, Taiwan’s National Health Insurance expenditure was 3.2% of gross domestic product (GDP) and is expected to grow annually at a rate of 4.75%3, putting further strain on the healthcare system in the coming years. This trend, however, is not merely driven by an aging population, but also by economic performance, the universal healthcare coverage system and the 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. According to MOHW, Taiwan also had one of the highest per capita healthcare spending levels in the Asia Pacific region at US$2,621 per person in 2015, ranking 22nd among OECD countries4.

 

Main Competitors

The medical manufacturing sector in Taiwan mostly consists of small to medium sized enterprises. The sector is particularly strong in manufacturing products at the lower end of the technology scale. Taiwan is one of the world’s leading producers of wheelchairs, patient aids, rehabilitation products, bandages and other medical supplies, and basic medical and surgical instruments. The local sector has also gradually expanded into orthopedic and implantable products, contact lenses, and other medical instruments and devices such as blood pressure and glucose monitors.

The Taiwan pharmaceutical market is heavily reliant on imported drugs. Taiwan has approximately 1,900 manufacturers of Western medicines and about 200 Chinese medicine producers5. Most major international pharmaceutical companies are widely represented on the island.

Current Demand

Foreign imports are in high demand and supply 70% of the high-tech end of Taiwan’s medical device market. Imported advanced medical devices are generally from the United States, EU and Japan, a trend that is set to continue.

 

Registration Process

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 MOHW, companies that import to Taiwan must submit the required documentation through their Taiwan importers or subsidiaries. Generally the following documents are required by Taiwan authorities for shipments of medical devices, regardless of content or shipping method: Commercial Invoice, Certificate of Origin, Packing List, Pro forma Invoice, and Bill of Lading. Additionally, medical devices also require a free sale certificate. The certificate for medical devices may be obtained from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

Medical devices require an application for reimbursement review while pharmaceuticals require approval by the Taiwan Food and Drug Administration (TFDA) before entering the market.

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 risk classifications of medical devices must meet the following labeling requirements:

  • Label must include product name, license number, and the name and address of the manufacturer printed in Chinese;
  • Label must include the manufacturing date and/or 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.

Reimbursement

 

The pricing and reimbursement for medical devices and drugs in Taiwan are set by Taiwan’s National Health Insurance Administration (NHIA). Once approval from Taiwan FDA (TFDA) is granted, the new medical device or drug manufacturer needs to submit an application with NHIA.

Following evaluation by a committee of stakeholders, the NHIA then decides whether a new medical device or drug will be listed for reimbursement. If a new product is added to the reimbursement list by the NHIA, its reimbursement price will be determined by the administration, and the product can be used at any healthcare facility in Taiwan.

Barriers

 

According to the U.S. Trade Representative (USTR) “2016 National Trade Estimate Report”, stakeholders continue to underscore the need for greater transparency and predictability in Taiwan’s pricing and reimbursement policies for innovative pharmaceuticals in Taiwan’s healthcare system. Concerns remain over the pilot drug expenditure target (DET) program’s inconsistent treatment of reimbursements for patented pharmaceutical products, the calculation of annual drug expenditure targets, and confusion over what actions will be taken if targets are exceeded.

As for medical devices, the National Health Insurance Administration (NHIA) currently does not provide reimbursement for implanted devices. Implants and a range of other commonly-used devices not approved for reimbursement must be issued a self-pay code, but this option is currently not available to a range of other non-implantable devices. Stakeholders have also expressed concern that the current balance billing system, which allows partial patient self-pay for high-end devices, does not clearly distinguish the effectiveness of different devices.

Procurement & Tenders

http://web.pcc.gov.tw

 

Trade Events

Taiwan International Medical & Healthcare Exhibition 2018 (MEDICARE Taiwan): June 21-24, Taipei

Bio Taiwan 2018 Exhibition: July 19-22, Taipei

ECA – Elder Care Asia: November 2-5, 2017, Kaohsiung

  

FAQs

Taiwan Food and Drug Administration (TFDA). Telephone: +886-2-2787-8000.

TFDA medical devices registration inquiry hotline: +886-2-8170-6008

Taiwan Center for Drug Evaluation (CDE): +886-2-8170-6000

 

U.S. Commercial Service Contact Information

 

Name: Evan Gao             

Position: Commercial Specialist          

Email: evan.gao@trade.gov            

Phone: +886-2-2720-1550 ext. 311              

Best Prospects

Below are the most promising subsectors:

  • Cardiovascular equipment
  • Endoscopy
  • 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
  • Catheters
  • Artificial joints
  • Prepared diagnostic and laboratory reagents

Market Size

Healthcare spending (including investment)

1,029,182 million NT$

... as percent of GDP

6.14%

... of which spent on inpatient services (including long-term care)

22.18%

... of which spent on pharmaceuticals/consumables

25.45%

... of which spent on investments

 

... of which spent on outpatient services

49.51%

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

494

…Public

81

…Private

413

Number of hospital beds

162,163

... available beds per capita

56.8 beds / 10,000 population

     ...of which in general hospitals

133,335

     ...of which in specialized clinics and rehabilitation centers

28,828 (clinics)

Physicians

44,006

Dentists

13,502

Demographics

Population

23,464,787

Life expectancy men/women

80.1 years (total population)

77 years (male)

83.5 years (female)

Infant mortality

4.4 deaths/1,000 live births

Percent of population older than 65

13.07%

...projection, 2030

23,586,654 (medium variant)

Annual deaths

7.3 deaths/1,000 population

1 US Census https://www.census.gov/foreign-trade/statistics/highlights/top/top1705yr.html

2 2016 onward NHI Expenditure figure isn’t yet available

3 2015 NHI Expenditure & Growth Rate: 2016 – 2017 NHI Annual Report/ 2015 GDP: Taiwan Directorate-General of Budget, Accounting, and Statistics (DGBAS)

4 MOHW 2016 Report p.26. (2017 Report isn’t yet available)

5 Source: BMI Research


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