Successful Medical Device Registration in Taiwan
In 2021, Taiwan’s “Medical Device Act” came into effect, establishing new regulations for medical devices in the country under the supervision of the Taiwan Food and Drug Administration (TFDA).
The level of effort required to register a medical device in Taiwan depends on the risk class, which is divided into Classes I, II and III. For example, manufacturers of Class II and III medical devices must, among other things, provide evidence that their quality management system complies with Taiwanese requirements (Quality System Documentation, QSD).
In addition, non-Taiwanese manufacturers must appoint a local representative (Taiwan Agent) to submit the registration application to the authority.
What makes our seminar unique?
In this interactive seminar, you will not only learn about the various requirements, but we will also use your products as examples to show you which approval process is right for you and how to navigate the approval process.
Numerous illustrative examples and practical tips will help you successfully register your product in Taiwan.
- Content
- Regulatory and Legal Requirements
- Organization of the TFDA
- Overview of the HPA Legislation
- Taiwan Agent
- Access to the Taiwanese Market
- Product Classification
- Determining an Appropriate Approval Procedure
- Quality Management Requirements: Quality System Documentation (QSD)
- Regulatory and Legal Requirements
- Your Benefits
- You will learn about the various requirements for product approval in Taiwan.
- You will walk through the approval process for your specific product during the seminar.
- You will understand the structure of the Taiwan Food and Drug Administration (TFDA) and how the approval process works.
- You will receive practical solutions tailored to your business.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- RA Specialists
- QM Specialists
- Medical device developers and manufacturers
- Project managers
- Medical device manufacturers and exporters
