Taiwan

Taiwan Food and Drug Administration – Medical Devices Division (Taiwan FDA or TFDA)

Medical Devices Act

Class I: 1–2 months

Class II: 7–8 months

Class III: 8–12 months

Chinese

5 years

country resident

A manufacturing site inspection is not required except for high-risk products (e.g. heart valves). However, for most devices, a paper-based quality system review, called a QSD, is required

A brief algorithm for registration of medical devices in Taiwan:

Determining the classification of medical devices

Verification of classification

Application for registration

Preparation of registration documents and payment of fees

Class I, II, III may be further categorized into IVD and Non-IVD

Application shall be submitted to Taiwan Food and Drug Administration

Documentation review:

Applications for Class II, III medical devices and new medical devices undergo two stages of review: Administrative and Technical.

Class I products require only administrative review.