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The Taiwan Food and Drug Administration (TFDA), a branch of the Ministry of Health and Welfare, is in charge of monitoring medical devices. Starting in May, the new Medical Devices Act will control the regulatory framework.
Classifying the product into one of the four categories listed below is the first step in selecting the regulatory pathway:I class (Low Risk),Type II (Medium Risk),Type III (High Risk).New (No predicate device previously approved by TFDA) (No predicate device previously approved by TFDA).
Applications for Class II, Class III, and New Medical Devices will be reviewed in two stages: administrative and technical. Products in Class I simply need to undergo an Administrative Review.
Only Class III IVDs and new products need clinical data. Class II medical devices with US or EU approval can typically substitute preclinical testing, quality control procedures, and test results with existing documentation.
The License is good for five years after it is issued. In Taiwan, licences can be transferred, although doing so requires cooperation from both the transferor and the transferee.
Taiwan medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
The Taiwanese government intends to introduce new standards for distribution, unique device identification (UDI), and other processes with the publication of new medical device legislation.
Through a phased implementation plan, Taiwan’s Medical Devices Act (link in Chinese) creates a new regulatory framework for medical devices. Several essential components of the new rule that the Taiwan Food and Drug Administration will implement (TFDA).
The Premarket E-Submission Portal was set up by the Taiwan Food and Drug Administration with the goal of making it simpler for manufacturers to submit their applications.
The new system, which is applicable to Class II and III items and will enable paperless submission, was introduced in March. This was done in an effort to hasten the application process after the new regulations took effect in 2021. Although not required, manufacturers are encouraged to use the system.
Only Class III IVDs and new products need clinical data. Preclinical tests, quality control procedures, and test reports are typically not required for Class II medical devices that have received approval in the US or EU. Instead, existing documentation can be used.
