New requirement for imported medical devices announced by Taiwan FDA

Taiwan FDA officer had explained that Medical Devices Act will be effective this coming 2021-05-01. In addition to meet the regulations, the electronic application pathway is also announced and explained in the online webinar held on 2021-04-06.

The electronic signature on the application documents signed by foreign suppliers can be accepted only if the supplier had her own published procedure book/SOP/working guidance on electronic signature application in her own management system. Otherwise, only the handwriting signature on the hard copy can be accepted for the imported medical devices registration(certification) application to Taiwan FDA.

Assistance with Taiwan FDA Regulations