Five years after Taiwan first urged medical device manufacturers to include unique identification (UDI) codes on the labels of their products, regulators are seeking public consultation on making the voluntary labeling protocols mandatory.
The draft requirements would mandate UDI labels include a host of identifiers, including license and serial numbers, license type and expiration date, batch numbers, and date of manufacture. Under the guidelines, the UDI labels would be carried on the actual package or body of Class II and Class III medical devices, or on the smallest unit of the device available for sale.
In addition, manufacturers would need to upload the same information to the medical device identification system database of the Taiwan Food and Drug Administration (TFDA).
Devices exempt from the draft requirements include personalized devices and single-use non-implantable in vitro diagnostic medical equipment.
Feedback on the draft requirements is being sought by the TFDA until Jan. 4.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------