Taiwan Authorized Representative (AR)

Foreign manufacturers without a legal entity in Taiwan must appoint a local Authorized Representative (AR), also referred to as a Taiwan Agent, before they can market medical devices or in vitro diagnostics (IVDs) in the country. The Taiwan Agent serves as the official representative of the manufacturer and acts as the primary point of contact with the Taiwan Food and Drug Administration (TFDA), operating under the Ministry of Health and Welfare (MOHW).

Beyond facilitating regulatory communication and helping foreign manufacturers to navigate Taiwan's regulatory framework, the Taiwan Agent plays a central role in ensuring that your products remain compliant with Taiwanese medical device regulations throughout their lifecycle. From registration to documentation, they provide the local regulatory presence required to successfully place and maintain medical devices on the Taiwanese market. 

Liaison with TFDA

Your Taiwan Agent acts as the official regulatory liaison between your company and the TFDA. They manage communications with the authority, respond to regulatory inquiries, and help ensure that all interactions with the TFDA are handled efficiently and in accordance with local requirements.

Registration

To perform regulatory activities in Taiwan, your agent must hold a valid Pharmaceutical Sales License. The Taiwan Agent is responsible for preparing and submitting your device registration dossier to the TFDA and guiding the registration process. After approval, the Taiwan Agent also maintains your registrations, including the Quality System Documentation (QSD) License and the Medical Device Product License, helping to keep them valid throughout the product's lifecycle.

Documentation

Your Taiwan Agent supports the QSD License process by preparing and submitting the necessary quality system documentation to the TFDA. Your Taiwan Agent’s details must appear on the Chinese label of your device, along with the registration number. In practice, local distributors typically add own contact details using a sticker to comply with local requirements.

Compliance

Your Taiwan Agent ensures compliance with TFDA regulatory requirements and remains responsible for maintaining your TFDA-approved Medical Device Product License. The Taiwan Agent also supports your ongoing regulatory compliance after market approval. This includes managing regulatory updates and coordinating the reporting of Serious Adverse Events (SAEs) to the TFDA whenever required.