Class II Medical and Diagnostic Devices manufactured from June 1st, 2023 on must be compliant with UDI (Unique Device Identification) labelling and reporting requirements in Taiwan. These requirements do not apply to Medical/Diagnostic Devices manufactured prior to that date.

In order to ensure compliance, manufacturers will need to work with their license holder to upload UDI and corresponding product information to the Taiwan UDI Database (TUDID).

If you have questions concerning UDI compliance in Taiwan or other Asian markets, please contact us here to set up a consultation.

Class II Medical Devices Require UDI Labelling in Taiwan

In 2021, the TFDA introduced the Medical Device Act, which among other regulations, introduced a timeline for UDI Labelling/Reporting for newly manufactured Medical and Diagnostic Devices, which stretched out across three years. Per these regulations, the following requirements were laid out: 

• Class III implantable devices require UDI labelling/reporting, which began in June 2021,
• Class III non-implantable devices require UDI labelling/reporting, which began in June 2022,
• Class II moderate risk devices require UDI labelling/reporting beginning June 2023.

Note: An amendment application is not required for adding UDI to a device’s labelling.

Grow With Us

Asia Actual is available to help navigate the medical device registration requirements and regulatory pathway for medical devices and IVDs in Taiwan. 

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.