On February 14, the Taiwan FDA (TFDA) promulgated new regulations for Class 2 and Class 3 medical devices. For these devices, a UDI code needs to be stamped on the outer frame of every packed medical device. For very small devices, the UDI code must be stamped on the outside of the sales package. If the device is custom-made, for export only, or a medical component only, no UDI code is required. This is a new update from the initial UDI regulation issued in Taiwan in the Spring of 2020.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.fda.gov.tw/ENG/newsContent.aspx?id=28380