FDA Taiwan Medical Device Registration

The Taiwan Food and Drug Administration (TFDA) is the regulatory authority responsible for overseeing Taiwan medical device registration and compliance. The Medical Devices Act (2021) governs the regulatory framework.

Medical devices in Taiwan are classified based on their risk level: Class I (lowest risk), Class II, and Class III (highest risk). This classification determines the regulatory requirements for medical device Taiwan, including the necessity for a technical dossier for Class II and III devices, which must include test reports and clinical data.

Foreign manufacturers must appoint a Taiwan Agent to facilitate interactions with the TFDA. Additionally, they must obtain ISO 13485 certification for all devices, excluding Class I non-sterile devices. Under TFDA regulations, manufacturers must also submit a quality system review application to obtain a Quality System Documentation (QSD) certificate, followed by the device registration application.

ISO 13485 certification is required for all medical devices except for Class I non-sterile devices. This certification is part of the quality and safety standards emphasized by the Medical Devices Act (2021) and is necessary for the Taiwan FDA medical device registration process.