Announcement of medical devices shall be indicated Unique Device Identifier.

In February 2023, TFDA established the Regulations for Medical Devices are required to place UDI on labeling or minimize package based on Article 33, of the Medical Device Act, and abolished Announcement No. 1101602479. The regulations require that UDI be displayed on the primary packaging or the device itself for class II and III medical devices. If the packaging or device is too small, the UDI should be marked on the smallest sales package.

What is a UDI?

Unique Device Identification, also known as UDI, is a unique identifier consisting of a series of digits or alphanumeric characters established by coding organizations for a specific type and specification of medical device.

UDI includes human-readable interpretation, HRI such as alphanumeric characters and automatic identification technology markings, i.e. barcodes, which must conform to international standards for one-dimensional/two-dimensional barcodes or radio-frequency identification.

UDI contains two parts: the device identifier and the production identifier:

• Device Identifier, DI which is used to identify the manufacturer, model, and version of the product. As it represents a specific device specification, the DI should be unique. The DI should be updated when the device is repackaged or updated.
• Production Identifier, PI which is used to identify information such as batch number, serial number, manufacturing date, and expiration date.

The purpose of mark UDI on a medical device is to make authority or users (such as medical institutions, medical professionals, and patients) :

• Easier search medical devices information on UDI database;
• Traceability of medical devices easier;
• Prevent falsified devices;
• Easier recalls of medical devices under specific circumstances.

Responsibilities of Manufacturers:

• Assign the UDI and base UDI-DI;
• Mark the UDI on the devices’ label or smallest package.
• The related information of medical device shall be submitted and transferred to the Unique Device Identification Database, UDID.

UDI exceptions of class II and III medical devices

• Customized devices;
• Devices for export only;
• Medical device combination packs used only for IVD, used only once, not for individual use, and not for sale as a non-implantable medical device component.

The related information which shall be submitted and transferred to UDID:

The devise which are UDI exceptions

TALENT has experience in counseling medical device manufacturers on the implementation of UDI for their products. If you need any consultation, please feel free to contact us.