Understanding the Different Classes of Medical Device Licenses in Taiwan

When entering the medical device market in Taiwan, one of the most important regulatory steps is determining the correct classification of your product. Taiwan classifies medical devices into three categories...

QSD (Quality System Documentation)

When it comes to registering medical devices in Taiwan, one critical component is obtaining a Quality System Documentation (QSD). QSD serves as a paper-based evaluation and acts as a substitute for onsite...

Becoming a License Holder in Taiwan: Eligibility and How Wonderville Can Assist

We get asked two questions all the time when it comes to medical device registration in Taiwan: Can I register my device as an individual? and Can I use my existing company (from another country) to register...