TFDA outlines new UDI requirements for medical devices in draft guidance

The Taiwan Food and Drug Administration (TFDA) published a draft guidance document (link in Chinese) for public consultation on November 5. The guidance ​​outlines new requirements relating to the creation and application of Unique Device Identification (UDI) information for medical devices and IVDs.

Guidance addresses UDI labeling and uploading information to database

Under the new requirements, Class II and III medical devices and IVDs will need to be labeled with UDI information on the body of the product itself or on individual packages. In cases where the product is too small for this condition to be feasible, the UDI labeling may be applied to the smallest unit of bulk packaging used for sale. The guidance also lists certain types of products that are exempt from UDI labeling requirements, including personalized medical devices.

The TFDA will require UDI information for products to be uploaded to a dedicated database, here referred to simply as the UDI Database or UDID. Two annexes to the guidance provide details on the composition of product numbers and bar codes, along with requirements for their inclusion in the UDID.

Phased implementation of UDI requirements will begin with higher-risk devices

The proposed timelines for mandatory implementation of UDI requirements are as follows:

• Class III implantable devices – June 1, 2021
• Class III non-implantable devices – June 1, 2022
• Class II devices – June 1, 2023

The TFDA will be accepting public feedback for 60 days from the date of publication of the draft guidance. Contact information is provided in the announcement. 

More resources on global UDI requirements from Emergo by UL:

• Medical device UDI consulting and training
• EU IVDR gap assessment
• Whitepaper: Understanding US FDA UDI regulation
• Whitepaper: An introduction to South Korea’s medical device UDI system
• Webinar: NMPA medical device registration requirements in China