Taiwan - Draft Regulation on the Unique Device Identifier (UDI) on Medical Device Labels

ARQon
Jul 8, 2021
2 min read

On 5 November 2020, Taiwan announced a draft regulation for their Unique Device Identifier (UDI) Requirements for Medical Device Labels. All imported and domestic Class II and Class III medical equipment will be subjected to this legislation. Exemptions are allowed for customised medical equipment, special medical equipment for export, or Non-implantable medical equipment components of medical device kit or IVD medical equipment that are for single-use only and are not use separately and sold

The UDI should be placed on the single package or device body of the second and third level medical devices. If the single package or the device is too small, the UDI may be placed on the minimum sale package.

UDI Database (UDID) The owner or license holder of the medical device shall upload the corresponding product information of the UDI to UDI Database (UDID) established by Taiwan FDA. Some of the required information are license number, license type, catalog number, device description, serial number and technical details. UDI Coding & Marking principles

Device Identifier (DI) to represent the model and specification of a medical device. In the event that the device changed to a new model or new package, the DI should be updated.
Production Identifier (PI) to recognize product information such as batch number, serial number, manufacturing date, shelf life etc.
The UDI label should include Human Readable Interpretation (HR) & Automatic Identification and Data Capture (AIDC) format.
The UDI label is not intended to replace or modify the original medical device label.
The AIDC acknowledged one-dimensional barcode, two-dimensional barcode or radio frequency identification (RFID) electronic tags.
The UDI label should be clear and identifiable during the product life cycle.
Individual UDIs are required for reusable medical device kit or IVD that have the potential to be separated from other components of the kit.
The version number of the software should be used as the PI.