Taiwan is one of the the most advanced medical device markets in Asia with more than 70% market share contributed by foreign manufacturers. Due to its economic performance, rising demand of healthcare products from a rapidly growing aging society as well as National Health Insurance that covers almost all of its 23 million population, the medical device market in Taiwan is projected to grow by over 7% from 2014-2019. This certainly marks Taiwan as one of the most exciting medical device markets for import opportunities.
After the reform of Taiwan’s medical device regulations, the premarket assessment of high-risk products has adopted a kind of hybrid approach, with a largely GHTF style model mixed in with elements of US style regulations. Review is focused on comparisons with established predicate devices, detailed pre-clinical testing and quality control reports. In addition, the Summary Technical Documentation (STED) and Essential Principle (EP) Checklist are also required as part of the pre-market submission for high-risk devices.
Our Webinar (15th March) will walk you through everythe process for registering medical devices with the Taiwan and Drug Administration (TFDA), including TFDA’s introduction of STED format for the technical documentation for Class III submission. The key points which will be addressed in this topic are as follows:
- An overview of the medical device market in Taiwan
- Regulatory framework and reforms relating to medical device registration
- Quality System Documentation (QSD) review process
- Classification scheme and the associated regulatory requirements
- STED format mandatory for Class III technical file
- Labelling requirements
Register Now and join Rachel Tserng, Senior Regulatory Consultant on Wednesday 15th March @ 8:00am AEST to hear further details about the unique regulatory requirements for TFDA.