Taiwan: TFDA shifts device submissions to online review from October

On 25 August 2026 TFDA announced two measures for medical device registration, license variation and extension, taking effect on 1 October 2026 (ROC year 115). The measures are a trial of online review with originals retained for reference, and an end to issuing paper approved copies of labels, instructions for use or packaging.

What changes on 1 October 2026

• Class I, II and III applications filed through the electronic submission system must complete the forms in the system and upload colour-scanned PDFs of originals, including foreign free-sale certificates, manufacturer authorizations, declarations, labels, instructions and packaging.
• After an electronic variation or extension is approved, the applicant sends a copy of the approval letter and the original license within one month so TFDA can update the license and return it.
• Approved Class II and III registrations and variations, whether filed on paper or electronically, will no longer receive a paper approved copy. The electronic version on the TFDA license system replaces it, carries an electronic seal, and voids earlier approved copies. Old paper copies do not have to be returned.
• Paper filings may attach one draft of the label, instructions or packaging instead of two.
• Fees for applications filed through the electronic system are paid only through that system’s payment platform.

Source: TFDA announcement, 25 August 2026.