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 the device? Unfortunately, the answer to both is no. To legally register and import a medical device in Taiwan, you’ll need to go through a locally registered entity.

Local Company Requirement for Registration
To put it simply: you must have a local company registered in Taiwan to register a medical device. Even if your company is already established abroad, it won’t be enough to register your device under that company’s name. Taiwan’s regulations require that the registration process is handled by a company that's set up in the country.

Medical Device Business Permit and Import Technician
Once your local company is established, the next step is obtaining a Medical Device Business Permit. In order to get this permit, your company must have a registered Import Technician. This person ensures that the devices you're importing comply with Taiwan’s regulations.
Here’s a helpful note: the Import Technician doesn’t have to be an outside hire. It could even be the company owner or another member of your team, as long as they meet the necessary qualifications for the role.

Assistance in Company Setup and Licensing
While Wonderville doesn’t directly assist with setting up companies, we can refer you to a trusted local accountant we’ve worked with for years. They specialize in helping international companies get established in Taiwan, ensuring that all the regulatory requirements are met. From company registration to securing your medical device business permit, we can point you in the right direction for the help you need.

Responsibility of the License Holder
Now, it’s important to note that the holder of the medical device business permit has a significant responsibility. This includes ensuring the device complies with regulations throughout its lifecycle, as well as managing post-market activities like recalls.
This is different from the role of a representative in other countries, where the representative may not have the same level of responsibility for the device’s compliance after it hits the market.

Wonderville as License Holder
At Wonderville, we’re ready to act as a license holder for select clients. However, we are very selective about who we work with. We only accept clients who adhere to the highest standards of legal compliance and ethical business practices. Our commitment to regulatory integrity is key, and we ensure that all involved parties meet Taiwan’s legal requirements.

Conclusion
To sum it all up, if you’re planning to register a medical device in Taiwan, you’ll need to establish a local company, obtain a Medical Device Business Permit, and ensure that an Import Technician is part of your team. While Wonderville doesn’t handle company formation directly, we can refer you to a reliable local accountant to guide you through that process. We can also help you with securing the necessary permits and even act as a license holder for qualified distributors. However, we are discerning in our selection and work only with those who are fully compliant with Taiwanese laws.
​
If you’re ready to start the process or have any questions, don’t hesitate to get in touch. We’re here to help you navigate this journey with ease and ensure full compliance.