Taiwan Moves Device Filing Online on 1 October 2026 — And 8,322 Licences Renew Into It

On 25 August 2026 Taiwan's FDA announced that from 1 October 2026 it will stop accepting paper originals for medical device registration, licence variation and renewal, and will stop issuing paper approved-copies of labels, instructions for use and packaging. Both measures are formally a trial (試行), announced by TFDA's Medical Devices and Cosmetics Division under reference FDA器字第1151608570號函.

It reads like an administrative housekeeping notice. For anyone holding a Taiwanese licence it is not, for two reasons. The first is that the document set it digitises — Certificate of Free Sale, foreign manufacturer's letter of authorisation, declarations, labelling — is precisely the set that foreign manufacturers depend on their local licence holder to handle. The second is arithmetic: 8,322 Taiwanese device licences come up for renewal in the first twelve months of the new regime, and 5,147 of those in the first six months alone.

What actually changes

1. Online review, originals retained rather than posted

For Class 1, 2 and 3 registrations, licence variations and renewals submitted through TFDA's electronic submission system, every document that previously had to arrive as a paper original — the Certificate of Free Sale from the country of origin, the foreign manufacturer's letter of authorisation, the various declarations, labels, IFUs and packaging — is now completed in the system and uploaded as a colour scanned PDF. The paper originals are no longer posted to TFDA. The device firm or licence holder keeps them on file for inspection.

There is one important exception, and it is the part most likely to be missed. Where a variation or renewal is approved through the electronic system, you must still post TFDA a copy of the approval letter together with the original paper licence certificate (醫療器材許可證正本) within one month of receiving the approval, so the licence can be endorsed. TFDA returns it. The envelope needs the approval letter's reference number and the name of the TFDA case officer written on it. So the paper trail does not disappear — it inverts. You stop posting documents to get a decision and start posting a certificate after you have one, on a clock.

2. No more paper approved-copies of labelling

From the same date, approved Class 2 and Class 3 registrations and variations no longer receive a paper approved-copy of the label, IFU or packaging. The controlled version becomes the electronic one published in TFDA's licence system, carrying an electronic straddle seal (電子騎縫章), which anyone can look up, download and print.

Several practical consequences follow:

• Paper submissions now need one copy of the labelling draft rather than two.
• Variations that change the device firm name, the manufacturer's name or address, or the Chinese or English product name must include the new labelling as an electronic file at the point of application.
• Variations that cancel or delete a specification must do the same.
• When a labelling variation is approved, TFDA publishes the new electronic version and voids every earlier approved version automatically. Old paper approved-copies do not need to be returned — but they also stop being the controlled document the moment the new one publishes.

That last point is the one to take back to your quality system. If your document control procedure treats a TFDA paper approved-copy as the controlled artefact, that procedure is out of date on 1 October. The controlled artefact is now a record in a government database that can change without anything arriving in your post.

3. Fees move to the platform, and only the platform

For anything filed through the electronic system from 1 October, fees can be paid only through the system's electronic collection platform. Four channels are offered: online credit card, internet or physical ATM transfer, over the counter at Bank of Taiwan, or at a convenience store. If your local partner currently settles TFDA fees by any other route, that route closes.

Separately — and not part of this announcement — TFDA published a draft amendment to the medical device administrative fee schedule on 30 June 2026. Fee levels are a different question from fee mechanics, and that draft is worth tracking on its own.

Why this matters more than a process notice usually would

Taiwan occupies an unusual position in how Western manufacturers actually expand, and it is not the one most market-entry decks assume.

Across our corpus, of the manufacturers holding a United States or European Union registration who hold exactly one Asian registration, Taiwan is that single Asian market more often than any other — 27.1%, or 1,456 companies. Thailand is second at 15.2% and South Korea third at 13.7%. Singapore, which is routinely described as the Asian gateway, accounts for 3.5%. Japan accounts for 1.3%.

Sole Asian market held	Manufacturers	Share
Taiwan	1,456	27.1%
Thailand	817	15.2%
South Korea	735	13.7%
Vietnam	456	8.5%
Malaysia	449	8.4%
Indonesia	422	7.9%
India	310	5.8%
China	296	5.5%
Singapore	187	3.5%
Hong Kong	105	2.0%
Japan	69	1.3%
Philippines	69	1.3%

Read that carefully, because it is a statement about where a single-market Asian footprint sits, not proof of the order companies moved in. But the implication holds either way: for a large population of US and EU manufacturers, Taiwan is their entire Asian regulatory presence. A change to how Taiwan processes filings is, for those 1,456 companies, a change to how Asia works — and many of them are exactly the mid-size manufacturers least likely to have someone reading TFDA announcements in Chinese.

That is the other reason this is easy to miss. TFDA published it on its Chinese-language announcements page. It is not on the English site.

Who is exposed, and how much

Taiwan's register holds 93,061 device registrations from 19,077 distinct manufacturers — a register with roughly the same record count as Japan's spread across five times as many companies. Taiwan publishes an expiry date on every one of those records, which is unusual and means the renewal exposure can be counted rather than estimated.

Exposure	Registrations
Total Taiwanese registrations on the register	93,061
Renew between 1 Oct 2026 and 31 Mar 2027	5,147
Renew in the first year (1 Oct 2026 – 30 Sep 2027)	8,322
Recorded as Class 2 or Class 3 (at least)	24,736

The Class 2/3 figure is a floor, not a total: 49,850 Taiwanese records carry no risk class in the public register, so the true number affected by the labelling change is higher. We would rather give you a number we can defend than one that looks more impressive.

What to do before 1 October

1. Find out who is actually filing for you. In Taiwan the licence sits with a local entity. Every mechanical change here — the scanning, the platform fee payment, the one-month certificate return — lands on them, not on you. Confirm they know about it. The announcement is six weeks old at publication and only exists in Chinese.
2. Check whether any of your licences renew in the window. If you have a renewal falling between October and March, it is going through a process that is new for everyone, including the reviewers. Build slack into the timeline.
3. Get colour scans of your originals now. Certificates of Free Sale and letters of authorisation are the classic long-lead documents. The requirement is a colour scan of a valid original — which means the underlying original still has to be current, legalised where required, and in your possession.
4. Fix your document control before it breaks. If a TFDA paper approved-copy is referenced anywhere in your QMS as the controlled labelling artefact, update the procedure to point at the electronic version in TFDA's licence system.
5. Confirm the fee route. If your partner pays TFDA fees outside the electronic platform today, that stops working for electronically filed cases on 1 October.

The wider signal

Taiwan is not doing anything unique here. Fully electronic submission, authority-published controlled labelling, and originals retained by the applicant rather than surrendered to the regulator are the direction of travel across Asia. What is worth noticing is the shape of the transition: Taiwan is not removing the paper obligation so much as moving it, from a pre-decision requirement onto the applicant's own records, backed by an inspection right. The burden does not vanish. It converts from postage into record-keeping, and record-keeping is the kind of obligation that is easy to fail quietly, years later, in an audit.

If you hold Taiwanese registrations and cannot immediately say who holds them, when they expire, or which of them are Class 2 or 3, that is the actual gap this announcement exposes — and it was there before TFDA published anything.

Sources and method

The regulatory content is from TFDA's announcement of 25 August 2026, FDA器字第1151608570號函, issued by the Medical Devices and Cosmetics Division and published on TFDA's Chinese-language announcements page. Read it in the original before acting on anything above; the enquiry line given in the notice is 02-8170-6008.

The counts are from Meridian Trace's corpus as at 25 August 2026: 93,061 Taiwanese registration records, and the cross-market manufacturer analysis drawn from 159,418 resolved manufacturer entities across 30 markets. Two limits worth stating. Entity resolution is a derived judgment, so the "sole Asian market" figures are directional rather than exact — a company registered in a second Asian market under a name we have not connected would move between rows. And 49,850 of the Taiwanese records carry no risk class in the public register, which is why the Class 2/3 number above is given as a floor.

This is not regulatory advice. Verify against TFDA's current guidance before making a filing decision.