Taiwan TFDA Trials Online Review and Electronic Label Approval from October 2026

Taiwan's Food and Drug Administration (TFDA) will trial two document-handling measures from 1 October 2026. The 25 August announcement and letter FDA器字第1151608570號 distinguish electronic submissions from the replacement of paper approved labelling. Their scope is different, and paper submission remains available.

Which applications are affected?

These are announced trial measures. The notice specifies their start date but no trial end date. It encourages use of the electronic filing system; it does not require every applicant to abandon paper filing.

Electronic filing still has a physical licence step

The originals covered by the upload-and-retain measure include the certificate of free sale, foreign manufacturer's registration authorisation, declarations, and labels, instructions for use (IFU) or packaging required by the applicable filing rules. The notice removes the need to mail those supporting originals to TFDA.

However, following an electronically approved licence amendment or extension, TFDA instructs applicants to send a copy of the approval letter and the original licence within one month of receiving the approval letter. TFDA endorses the licence and returns it. The mailing does not need a separately registered correspondence number, but the envelope must identify the approval-letter number and TFDA case officer shown in the letter.

This distinction matters: retaining the supporting originals does not mean retaining the original licence when this endorsement step applies.

How approved labelling changes

New electronic approved versions will carry an electronic seal across pages and can be searched, downloaded and printed from the licence system. TFDA also changes the handling of label, IFU and packaging files:

• Paper registration or amendment applications: one draft copy may be attached instead of two.
• Specified name changes: for amendments adding or changing the approved medical device firm's name, the manufacturer's name or address, or adding, deleting or changing the approved Chinese or English product name, applicants may attach an updated electronic file for publication after approval.
• Cancellation or deletion of specifications: the updated electronic file must accompany the amendment application.
• Approved labelling amendments: publication of the new electronic version voids all previous approved versions. Old paper approved copies do not need to be returned.

The change concerns TFDA's approved copies. It should not be read as general permission to remove physical labels or replace the IFU supplied with a product. Articles 32 and 33 of the Medical Devices Act separately govern Chinese labelling, required particulars and the devices for which electronic instructions are permitted.

Payment and preparation

From 1 October, fees for applications made through the electronic system must be paid through its collection platform. TFDA lists four channels: online credit card, web ATM or ATM transfer, Bank of Taiwan counter payment, and convenience-store collection. The announcement concerns payment channels; it does not announce new fee amounts. Its enquiry number is 02-8170-6008.

Pure Global analysis: prepare a filing checklist that separates three records: the retained supporting originals, the original licence needed for endorsement, and the current approved electronic labelling. Assign an owner for each and trigger the one-month endorsement task when the approval letter arrives. For amendment packs, distinguish optional updated electronic files from the mandatory file for specification deletions. This avoids treating all electronic submissions or all labelling amendments as the same workflow.

For the broader pathway, see Taiwan medical device registration and Taiwan TFDA.