Taiwan Medical Device Registration: Local Agent, Classification, and QSD Compliance

Taiwan Medical Device Registration: Local Agent, Classification, and QSD Compliance

Medical device regulations in Taiwan are overseen by the Taiwan Food and Drug Administration (TFDA), a division of the Ministry of Health and Welfare. The regulatory system is governed by the comprehensive Medical Devices Act, enacted in May 2021. For imported products, manufacturers must appoint a Local Agent or Importer to act as their regulatory representative.

Classification and Regulatory Pathway

The registration pathway, required documentation, and associated fees depend on the device’s classification:

• Class I (Low Risk): Requires only an Administrative Review. Most devices in this class have the shortest timeline (1–2 months).
• Class II (Medium Risk) & Class III (High Risk): Require both Administrative and Technical Reviews, leading to longer timelines (8–12 months and 9–14 months, respectively).
• New Device (No Predicate): A new category for devices without a previously approved predicate by the TFDA. These have the longest review timelines (10–15 months) and may require additional clinical data.

A key aspect of the process is identifying a predicate device (similar products previously approved by the TFDA) to support the application. Taiwan generally does not require approvals from reference countries (like the US or EU) as long as the device is registered in its country of origin and a Free Sale Certificate is provided.

Quality System Documentation (QSD)

Before a Class I (Sterile/Measuring), Class II, Class III, or New device can be marketed in Taiwan, manufacturers must demonstrate compliance with Taiwan Good Manufacturing Practice (GMP) standards through Quality System Documentation (QSD).

• Mandatory Scope: QSD approval is mandatory for all products except non-measuring, non-sterile Class I devices.
• Process: The QSD review can take 6–8 months and is often run concurrently with the device application review. Final registration approval is contingent on QSD approval.
• Expedited Pathway: Manufacturers can expedite the QSD process by utilizing an ISO 13485 certificate issued by one of the TFDA-approved Notified Bodies under the TFDA-EU Technical Cooperation Program (TCP III).

Key Registration Requirements

Required documents typically include:

• Application form and Authorization letter from the manufacturer.
• Copy of Chinese labeling, Instructions for Use (IFU), and packaging inserts.
• Free Sale Certificate (FSC) from the country of origin's health authority.
• Product structure, materials, specifications, and intended use documentation.
• Preclinical test reports and quality control procedures.
• Clinical Data: Required only for Class III In Vitro Diagnostic Devices (IVDs) and New products.

Once issued, a medical device license is valid for 5 years and is transferable between local agents with the joint execution of a transfer application.