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Taiwan FDA launches a new online Medical Device Electronic Pre-market Application Platform:TFDA Medical Device Premarket E-Submission System

【Update Date:2022-03-31unit:醫療器材及化粧品組

On January 21, 2022, the Taiwan Food and Drug Administration (TFDA) launched a new online pre-market application platform for medical devices, the TFDA Medical Device Premarket E-submission System. The system aims to provide manufacturers with an alternative way to submit pre-market application documents, so as to improve the convenience of pre-market applications for medical devices, and to comply with the trend of paperless, which can save the resources required to prepare paper documents. TFDA encourages but does not compel manufacturers to submit pre-market applications for class II and III medical devices through this new system.

According to the Medical Devices Act, for the manufacture and import of medical devices, an application shall be filed with the central competent authority (TFDA) for registration and market approval. No manufacture or import shall be allowed until such approval is granted and a medical device license is issued. All along, TFDA has always been committed to continuously improving the pre-market review of medical devices and harmonizing with international regulations. With the advancement of network technology and the demand for electronic remote application, since 2018, TFDA has also begun to develop an electronic document submission mechanism for pre-market applications for medical devices.

As the Medical Devices Act took effect on May 1, 2021, TFDA accelerated the development of the E-submission System, and officially launched the system on January 21, 2022. Information such as the “Implementation Instructions for the Application for E-Submission of Class II and III Medical Device Registration”, the system user manual and common Q&A were also released at the same time. Medical device manufacturers or dealers can choose to apply for Class II and III Medical Device registration, alteration of the registration or license extension through this E-Submission system. Details can be found in the “TFDA Medical Device Premarket E-submission System for Class II and III Medical Device Registration” area of ​​the TFDA official website (www.fda.gov.tw/TC/siteContent.aspx?sid=12014).