March 08, 2018
The regulatory body for medical devices is Division of Medical Devices and Cosmetics under Taiwan Food and Drug Administration (TFDA). The important legal rules that govern Medical Device Affairs are the Pharmaceutical Affairs Act and the Regulations for Governing the Management of Medical Device.
How are the medical devices regulated in Taiwan?
Premarket approval is required for all classes of medical devices prior to enter Taiwan market. In accordance to the function, intended use, instruction for use and working principle, medical devices are classified into 17 categories (similar to US FDA classification system) and three classes (I, III and III) according to their level of risks. The official turnaround time to get Class I, II and III device approval are 2-3 months, 6-8 months and 12-18 months respectively. Clinical data or clinical trial might be required for Class III and New Medical Devices.
Ø Can we appoint multiple distributors for identical medical device?
TFDA recognize and issue the license on the basis of their brand names. Each brand can only be represented by one In-Country Representative.
Ø What is the qualification request to be the owner of medical device registration certificate?
It requires a local legal entity who has the following three licenses:
a. A company establishment license from Ministry of Economic Affairs with business scope of medical device distribution,
b. A Pharmaceutical Company License from TFDA,
c. Good Distribution Practice (GDP) Compliance*: TFDA has completed the procedures of draft announcement in 2015 and it’s expected to be implemented soon.
Ø Do we have to appoint a distributor to manage our product registration certificate?
Foreign medical device manufacturers may appoint a third party representative to manage their device registration while product import and distribution may still be operated by your designated distributor.
Ø Any preclinical testing that we could take reference from?
To reinforce the safety and efficacy of medical device, TFDA has announced fifty-six preclinical testing guidance for public reference by 2016 and the list is still growing. Please click here to find out whether your device is enlisted.
Ø What are the custom duty and VAT in Taiwan?
Custom duty ranges from 0% to 10%. To identify the rate of your product, please click here (Customs Administration, Ministry of Finance). VAT is 5%.
Ø Want us to identify the class of your products or have more questions? Mail us now!
Facts about the Medical Device Industry in Taiwan
According to ITIS, Ministry of Economic Affairs, the medical device industry size in 2017 was 103 billion TWD (3.5 billion USD) at 2.5% growth rate. 42% of the medical device market is supplied by imports, of which the United States, Japan and Germany have been the primary import partners. Among imports, the United States holds one third, or approximately 34.9%, of the market share. The opportunity for imports is at the high-end medical equipment & devices and self-pay medical treatment on aesthetic, dental and ophthalmological aspects.
Due to limited market size, Taiwan manufacturers export the majority of their products to foreign markets. In 2017, the major exports are contact lens, antiseptic catheters (urological catheter & specialty catheter) and cannulas.
Distribution channels in Taiwan
According to the Ministry of Health and Welfare (MOHW) statistics, there are 22,384 healthcare institutions by the end of 2016 where hospitals and clinics accounts for 490 and 21,894 respectively. Statistic (Table 4) shows there is a continuing decrease in hospitals whereas a significant increase in clinics over the years. Decrease in hospitals is because small, independent hospitals and district hospitals are the most vulnerable to financial stress as occupancy rates decline and lack of facilities to attract patients comparing with medical centers and regional hospitals. Increase in clinics is contributed mostly by family medical clinics, aesthetic clinics and dental clinics.
83% of hospitals are private-funded whereas there were only 81 public hospitals by the end of 2016. The hospital accreditation system classified hospitals into medical centers, regional hospitals, district hospitals and clinics. Special diagnostic and treatment services are available in medical centers and regional hospitals. Based on the statistics from MOHW, we organized two tables below to show you the amount and area coverage for special diagnostic medical equipment in Taiwan. CT and MRI are general and evenly distributed where advanced and special treatment are allocated mostly in northern Taiwan.
Healthcare Expenditure Index and Future Medical Device Industry in Taiwan
With a population of 23 million and 20% of its population would be over 65 by 2025, Taiwan’s health expenditure is expected to grow driven by aging population and increasing prevalence of chronic diseases. In 2016, Taiwan’s National Health Expenditure (NHE) was 35 billion USD, 6.34% of its GDP whereas the health spending was 9% of GDP on average in the OECD. About 66% of Taiwan’s healthcare expenditures are funded by the public sector with the remaining 34% covered by out-of-pocket private spending. The health spending per capita in Taiwan was TWD 46,219 (USD 1,577) per person in 2016.
Through 23-year implementation of National Health Insurance, Taiwan has a maturely-developed healthcare environment and decade of national health statistic data, how to take advantage to use the big data through digital analytics and artificial intelligence is the future medical device industry developing focus.