Updated on 19 April 2013
What's the confusion about in Taiwan?
Taiwan is a major economic player in the domain of electronics, information and communication technology, and is also considered a producer of intermediary and final products. Although its size and economy is not as robust as its neighbor, China, the island nation of 23 million inhabitants has a per capita gross domestic product (GDP) of $20,000 and spends around seven percent of its GDP on healthcare, which is higher than what is spent by most of its neighbors in Asia Pacific. Moreover, nearly 99 percent of its population is covered by the National Health Insurance Scheme.
The medical device market in Taiwan is valued at about $1.8 billion and is the fifth-largest medical device market in Asia. However, surprisingly Taiwan imports 75 percent of its medical devices from overseas. This shows that a considerable number of medical devices are used in Taiwan and this demand for medtech devices is only going to increase as the nation's 20 percent population become over 65 of age by 2025.
In Taiwan, all medical devices require registration with the Taiwan FDA (TFDA), regardless of the fact of whether they belong to Class I (pose the lowest risk) or Class III (pose the highest risk). For combination devices, classification depends on the product's primary function. There are two applications required for Class II and Class III medical device registration in Taiwan, the Quality System Documentation (QSD) and Product Registration.
Regulatory changes made in 2012-13
During late-2012, the Taiwan FDA announced that it would start using the Summary Technical Documentation (STED) format for medical device technical document submissions, joining regions such as Japan, Australia, Canada, the US, and the European Union. This change occurred to align the country with the Global Harmonization Task Force standards and to aid the goal of achieving uniformity between various countries' regulatory bodies.
STED is expected to fully be implemented for all Class II and III medical devices by July 2013. For product registration, foreign medical device companies have henceforth been advised to include device description and product specification (including variants, components and accessories), as well as an essential principles checklist (including risk analysis and control summary, design and manufacturing process).