Class II Medical and Diagnostic Devices manufactured from June 1st, 2023 on must be compliant with UDI (Unique Device Identification) labelling and reporting requirements in Taiwan.
In order to ensure compliance, manufacturers will need to work with their license holder to upload UDI and corresponding product information to the Taiwan UDI Database (TUDID).
Taiwan's UDI labeling/reporting schedule extended over three years.
- After June 2021: Class III implantable devices require UDI labeling/reporting.
- After June 2022: Class III non-implantable devices require UDI labeling/reporting.
- After June 2023: Class II mid-risk devices require UDI labeling/reporting.
Please refer to the link to the UDI database below.
Refer from https://udid.fda.gov.tw/
If you have any questions about UDI labelling,
Please contact us with the email below.
info@jnmglobal.net
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