Taiwan Despite its small size compared with larger East Asian countries such as China and Japan, Ta

Taiwan
Despite its small size compared with larger East Asian countries such as China and Japan, Taiwan has one of the most developed medical device markets in Asia, boasting a market size of $1.6 billion. With a population of more than 23 million people, Taiwan’s potential for growth in the medical device market cannot be ignored.

The Taiwan Food and Drug Administration (TFDA) decided in May that it would adopt the Summary Technical Documentation (STED) system for registering medical devices. This will bring Taiwan’s medical device registration system on par with the standard outlined by the Global Harmonization Task Force (GHTF) in “GHTF SG1-N11: 2008—Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.” In an attempt to facilitate communication between regulatory agencies in different countries, the GHTF has been promoting the use of STED among medical device manufacturers and government regulatory agencies.

The implementation of STED in Taiwan will be phased in over the next year. From July through December this year, the Experimental Stage 1 (voluntary) for Class III medical devices will begin. Experimental Stage 2 (voluntary) for both Class II and Class III medical devices will take place January to June 2013; then, starting in July 2013, Implementation Stage 3 (mandatory) will be in effect for both Class II and III medical devices.

To ensure a smooth transition into STED, the TFDA encourages foreign medical device companies to submit a description of each product that includes its specifications, such as components and accessories. An essential principles checklist is available for foreign companies’ reference. Items on the checklist include design and manufacturing process, product verification and validation, risk analysis and control summary, as well as complete test reports for every STED (for Class III medical devices only).