Taiwan Medical Device Regulations

This process chart illustrates the TFDA approval process per device classification in Taiwan and is available for download in the Regulatory Affairs Management Suite (RAMS).

Overview of Taiwan medical device regulations

All manufacturers planning to sell a medical or in vitro diagnostic (IVD) device in Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA). All classes of medical devices require pre-market approval prior to entering the Taiwanese market.

Taiwan medical device regulatory approval process

The chart illustrates the TFDA approval process per device classification in Taiwan and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.

Step 1
Determine the classification of your device according to the TFDA’s device database.

Step 2
Appoint a Taiwan Agent to manage your device registration and interact with the TFDA on your behalf.

Step 3
Unless your device is exempt, prepare a quality system documentation (QSD) application. Submit the application and pay the associated fee. The TFDA will review your documentation and, upon approval, issue a QSD certificate.

Step 4
Prepare a registration application/dossier for submission to the TFDA.

Step 5
Pay the application fee. The TFDA reviews the application and may request additional information.

Step 6
Upon TFDA approval, you will be issued a registration license.

Log in to RAMS to view the chart

This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for Taiwan when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.

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