ANSWERED ON THIS PAGE:
- Do foreign manufacturers need in-country representation in Taiwan?
- What are the requirements of a Taiwan Agent?
- Can we choose a device distributor as our Taiwan Agent?
The Taiwan Food and Drug Administration (TFDA) requires medical device and IVD manufacturers with no office in Taiwan to appoint an in-country regulatory representative, referred to as a Taiwan Agent.
Taiwan agent qualifications, role, and responsibilities
Your Taiwan Agent must have a legal entity established in Taiwan, certified with a Pharmaceutical Sales License. Your Agent will:
- Submit all registration documentation to the TFDA on your behalf
- Assist with obtaining the Quality System Documentation (QSD) Approval Letter (required for Class II and III devices, and some Class I)
- Serve as a regulatory liaison between you and the TFDA
- Oversee Serious Adverse Event (SAE) reporting for your device, if necessary
- Assist with maintaining your QSD License and device registration
Once your product has been approved by the TFDA, your Taiwan Agent will hold your medical device registration, known in Taiwan as a Medical Device Product License. Your Taiwan Agent is also responsible for filing the import authorization request to the TFDA for each distributor so they can import. For this reason, we recommend selecting an independent regulatory representative to serve as your Taiwan Agent, instead of a distributor.
Please read our article on the benefits of independent regulatory representation.
Choose Emergo as your independent Taiwan agent for regulatory representation
From our office in Taipei, Emergo has the resources and expertise to act as your independent Taiwan Agent and fully support your TFDA medical device registration and QSD Approval. Here’s how we can help:
- As your Taiwan Agent, we will coordinate and submit all documentation required for registration, while communicating with the TFDA on your behalf.
- We will provide guidance on the QSD Application process, such as the QSD route, which sites require a QSD Approval Letter, and how to update your quality system to comply.
- We will assist with any Serious Adverse Event (SAE) reporting or device recalls, if necessary.
- We will assist with the TFDA registration renewal process (every 5 years) as well as the QSD renewal process, if required (every 3 years).
- Because we focus on regulatory compliance, we will keep up to date on potential changes in Taiwan that may affect your devices.
- Our experienced consultants stay up-to-date on the latest TFDA medical device regulations to ensure that you experience smooth and efficient registration process.
Please contact us for more information on our Taiwan Agent representation service.
Frequently asked questions
Does my Taiwan agent need to appear on the labeling?
Yes, as the Taiwan Agent’s information must be included on the Chinese label, along with the registration number. The distributor will also usually add their information with a sticker. the Taiwan Agent’s name and address must be listed on the label and packaging (in Chinese language).
Is ISO 13485 required?
Technically, no. However, for non-US and non-Japanese manufacturers, an on-site audit by the TFDA is the only alternative to providing an ISO 13485 certificate for the QSD Letter Application (which is applicable to some Class I, and all Class II and III devices, including high risk and new devices). US companies can alternatively submit a Certificate to Foreign Government (CFG) issued by the FDA. Japanese manufacturers can alternatively submit their Japanese QMS audit report and certification issued by the PMDA or RCB, as applicable.
Can registration certificates be transferred?
Yes, the Taiwan Agent responsibility can be transferred as long as the original Agent cooperates, as the request must be submitted by both agents. Additionally, the registration letter can be transferred simultaneously with the QSD Approval Letter.