Taiwan IVD Product Registration: High-Risk Classification and Mandatory QSD Compliance

In Taiwan, the regulation of In Vitro Diagnostic (IVD) products falls under the Taiwan Food and Drug Administration (TFDA), adhering to the new Medical Devices Act enacted in May 2021. For imported IVDs, manufacturers must appoint a Local Agent to serve as the official regulatory representative.

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IVD Classification and Registration

IVD products are classified based on risk from Class I (Low Risk) to Class III (High Risk), plus a New category for devices without a predicate.

A critical distinction for IVDs in Taiwan is the registration requirement:

• Class I and Class II IVDs: These low to medium-risk devices do not require product registration with the TFDA.
• Class III and New IVDs: These high-risk products require mandatory registration and are subject to both Administrative and Technical Reviews by the TFDA.

The registration process requires key documentation, including an application form, a Free Sale Certificate from the country of origin, the manufacturer's authorization letter, Chinese labeling, preclinical test reports, and quality control procedures. Clinical Investigation Reports and a Literature Review are specifically required for Class III and New IVD products.

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Quality System Documentation (QSD)

Before a registrable IVD can be legally marketed, the manufacturer must obtain approval for its Quality System Documentation (QSD). This documentation verifies the manufacturer’s compliance with Taiwan’s Good Manufacturing Practice (GMP) standards.

• Mandatory Requirement: QSD approval is mandatory for all registrable IVDs (Class III and New).
• Timeline: The QSD review process typically takes between 6 to 8 months and runs concurrently with the product application review. Final license issuance is contingent upon QSD approval.

The TFDA license, once approved, is valid for 5 years.

Fees and Timelines for Registrable IVDs