Taiwan Medical Devices Regulations

Registration Routes in Taiwan

Medical Device and IVD Registrations

Medical Device
Pre-market approval is necessary for all classes of medical devices before Taiwanese market entry. The TFDA issues a "medical device permit license upon product registration approval." 

If no similar devices have previously been approved by the TFDA, your device will be considered a PMA device in Taiwan. This is the case even if your product has a Substantially Equivalent (SE) device approved by the U.S. FDA. 

Class II and III devices must have approval from their home country before Taiwanese registration. 

Class I sterile, Class I measuring, Class II, and Class III medical devices must comply with GMP requirements before the TFDA grants product licenses.  

TFDA-authorized auditing organizations perform on-site inspections for local manufacturers by GMP and review quality system documentation (QSD) provided by foreign manufacturers. 

Before a medical device can be sold in Taiwan, Quality System Documentation (QSD) registration for the manufacturing facility is required in addition to medical device registration. QSD registration is only waived for Class I (non-sterile) medical devices. A QSD license (received upon QSD registration approval) in Taiwan is similar to a Good Manufacturing Practice (GMP) for medical devices. 

IVD 
The registration process for IVDs in Taiwan, overseen by the TFDA, varies according to the device's risk class, similar to that for medical devices. 

Class I and II IVDs: These devices do not require registration and are subject to less stringent regulatory requirements than higher-risk devices. 

Class III and New IVDs: These devices must undergo a two-stage review process, including Administrative and Technical Reviews. 

The Role of a Taiwan Agent in Medical Device Registration

Local Representative 

To sell medical devices or in vitro diagnostics (IVDs) in Taiwan, manufacturers without a local office must appoint an in-country regulatory representative, a Taiwan Agent. The Taiwan Agent is your liaison with the Taiwan Food and Drug Administration (TFDA) and is critical in ensuring compliance with Taiwanese regulations.

Your Taiwan Agent must:

• Be a legally established entity in Taiwan.
• Hold a Pharmaceutical Sales License to perform regulatory activities.

The Taiwan Agent provides comprehensive regulatory support, including:

• Registration Submission: Preparing and submitting all necessary documentation to the TFDA on your behalf.
• QSD Approval: Assisting with obtaining the Quality System Documentation (QSD) Approval Letter, which is mandatory for Class II, Class III, and specific Class I devices.
• Regulatory Liaison: Acting as the primary regulatory connection between your company and the TFDA, facilitating communication and compliance.
• SAE Reporting: Managing Serious Adverse Event (SAE) reporting should issues arise with your device.
• License Maintenance: Ensuring the QSD License and device registration remain current.
• Medical Device Product License Management: Holding your TFDA-approved Medical Device Product License, a requirement for all registered devices.

Your Taiwan Agent’s details must appear on the Chinese label of your device, along with the registration number. Additionally, distributors typically add their information using a sticker to comply with local practices.

The Taiwan Agent’s role is vital for navigating the complex regulatory landscape in Taiwan. They ensure your device meets all TFDA requirements, maintain your product’s compliance, and act as your local point of contact for regulatory issues.

Manufacturers can confidently expand their business into the Taiwanese market by appointing a reliable Taiwan Agent, ensuring compliance and a smooth approval process.

Contact us today to learn how Qserve can assist you in appointing a Taiwan agent and managing your regulatory needs in Taiw