Taiwan Medical Device Registration Consulting

Overview of medical device registration in Taiwan

ANSWERED ON THIS PAGE:

• How are medical devices classified in Taiwan?
• What are the TFDA medical device submission requirements?
• Do we need in-country representation to sell our medical device in Taiwan?

Taiwan medical device registration requirements

Medical device companies interested in commercializing their products in Taiwan must comply with registration requirements of the Taiwan Food and Drug Administration (TFDA). Pre-market approval is necessary for all classes of medical devices prior to Taiwanese market entry. With a presence in Taipei, we can assist with all aspects of the TFDA registration process, including application preparation and submission and in-country representation.

Medical device classification in Taiwan

What is the medical device classification process in Taiwan? Properly classifying your medical device is the first step towards registering your device in Taiwan. The Taiwanese regulatory system classifies devices as Class I, II or III depending on risk. Class II and III devices must have home country approval in place prior to Taiwanese registration.

Registering your medical device with the TFDA

For Class I devices, a registration application must be submitted to the TFDA for approval. Class II and III devices also require the submission of a dossier that includes technical information, product test reports and any necessary clinical data.

Additionally, the TFDA requires applicants to have Quality System Documentation (QSD) certification, prior to registration for many devices.

If you are located outside of Taiwan, you must appoint a Taiwan Agent to manage your device registrations.

Taiwan medical device registration with Emergo by UL

Emergo has many years of experience supporting clients’ medical device registration efforts in Taiwan. Here’s how we can help:

• We can assist you in properly classifying your device to ensure a smooth registration process.
• Emergo can compile the necessary documentation for registration application and design dossier submission.
• Our Taiwan Agent services allow us to submit application documents and communicate with the TFDA on your behalf.
• Our experienced QMS consultants can assist you with QSD certification, FDA QSR (21 CFR Part 820) and ISO 13485 compliance.

Taiwan medical device registration FAQs

How do I register a medical device for sale in Taiwan?
Taiwanese medical device market access requires applying for pre-market approval for your device from the TFDA. Higher-risk devices also require providing additional technical, testing and clinical data to Taiwan regulators. Foreign manufacturers must appoint Taiwan Agent in-country representatives to manage their registrations and liaise with the TFDA.

How are medical devices classified in Taiwan?
The Taiwan FDA uses a three-tier, risk-based classification system for medical devices and IVDs, from Class I (lowest risk) to Class III (highest risk). How your device is classified determines registration routes and documentation requirements for your registration.