Taiwan is a high-income country with considerable healthcare expenditures. The country imports about 70% of its medical device supplies and approximately 99% of Taiwan’s population is covered by governmental National Health Insurance. To keep its people active and healthy, Taiwan has a high demand for medical devices and pharmaceuticals, making it an attractive market for device manufacturers looking to export their products.
In this white paper, we provide a high-level overview of what it takes to start selling your medical device in Taiwan. You will learn:
quality management system requirements for foreign and domestic manufacturers
Taiwan Agent representation requirements
Steps in the product registration process
An overview of the priority review process
TFDA vigilance reporting requirements
Upcoming regulatory changes
and much more.
Download this 6-page white paper to learn how to register your medical device with TFDA.
