Taiwan TFDA Medical Device Registration Requirements

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.