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In Depth: Taiwan Medical Device Approval and Compliance

Interested in selling your medical device in Taiwan? If so, there are important steps you need to follow to comply with medical device regulations in this market. Taiwan has a robust medical device industry with a well established regulatory system, overseen by the Taiwan Food and Drug Administration. In this video series, we'll take a deep-drive into what it takes to sell a medical device in Taiwan, from quality system requirements to classification rules. Here's what you'll learn:

  • How to determine device classification and grouping options
  • What is the best registration route for your device
  • What to include in your registration submission to the TFDA
  • What are your post-market obligations once your device is approved
  • Do you need in-country representation in Taiwan
  • How do you comply with quality management system requirements

With a presence in Taiwan, Emergo is fully equipped to help you start selling your medical device in this market. Learn more about our Taiwan consulting services.