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.