Taiwan changed three things about device clinical trials between 21 September and 7 October 2026. From 1 October, sponsors must register their trial data on the TFDA's digital device-trial platform. From 5 October, every application, amendment, progress report and final report goes through that platform, using forms filled in online. And since 21 September, the TFDA has published notes on how trial sites may and may not advertise for participants.
None of this changes whether a trial needs approval, what evidence a trial needs, or what it costs. It changes how a trial is filed and how it is recorded. For a sponsor already running a trial in Taiwan, that means a new filing route and a June-and-December reporting duty in a new place. For a startup choosing where to run its first clinical study, the rules that matter most did not change, and two of them are more useful than most founders realise.
This is separate from Taiwan's move to online filing for registrations on 1 October, which is covered in our October round-up. Every item below is checked against the instrument itself; where something is our reading rather than the text, we say so. Taiwanese instruments are dated in the Minguo calendar: year 115 is 2026.
What changed
1. Trial data is registered on one designated platform (from 1 October)
What changed. Taiwan's device GCP regulation requires the sponsor to register each trial on a web page the authority designates, within 30 days of approval: sites, sponsor, principal investigator, title, approval number and date, objective, inclusion and exclusion criteria, number of participants, device name and trial phase. The sponsor must update the entry within 30 days of an approved amendment, and every June and December while the trial runs (Regulations for Good Clinical Practice of Medical Devices, Art. 7). By an announcement dated 30 September 2026 (115/09/30, 衛授食字第1151609789號), the Ministry of Health and Welfare designated the Digital Medical Device Clinical Trial Platform, mdctp.fda.gov.tw, as that page from 1 October 2026.
The platform itself is not new. It has published approved device trials and taken online applications since 1 May 2023. What is new is that it is now the place where the legal registration duty is met.
Who it affects. The sponsor. That is you, not your CRO or your site, although you can delegate the work in writing.
What to do. Check that every trial you have running in Taiwan appears on the platform and is up to date. The next scheduled update is December 2026. The announcement says nothing about trials approved before 1 October. Our reading is that the June/December duty applies to them from now on, so treat December as the first update under the new designation.
2. The application instructions now assume online filing (from 5 October)
What changed. The Ministry replaced the 2021 Application Instructions for Medical Device Clinical Trial Protocols with a revised version, effective 5 October 2026 (115/10/05, 衛授食字第1151610689號). We compared the two texts line by line. The document list for a new application is unchanged: 13 items, from the protocol and consent form to the investigator's brochure, preclinical data and insurance. What changed:
- No paper. The 2021 version asked for three paper sets plus a disc. The new version sends every filing type to the platform: new applications, amendments, progress reports and final reports.
- Forms filled in on the platform. The application form, the Chinese protocol summary and the per-site enrolment table are completed on the platform's web pages, not uploaded as documents.
- Amendments carry a refreshed Chinese summary. A protocol amendment must now include an updated Chinese summary, entered on the platform.
- Progress reports now include enrolment. The per-site enrolment table used to be required only at close-out. It is now part of every progress report. The progress report template adds a "screened so far" count, and the enrolment table now gives adverse events and serious adverse events as both event counts and participant counts, per investigator.
- File formats. Attachments must be searchable ODF or PDF. Word is no longer listed.
- Wording. The preclinical checklist now says "quality management system (QMS), ISO 13485" instead of "GMP", and cites ISO 16142-1 and -2 instead of ISO/TR 16142.
New applications have been fully electronic since 1 October 2025 under an earlier TFDA notice, which still allowed paper on request in exceptional cases. The new instructions do not mention a paper route at all.
Who it affects. Whoever files: a Taiwanese company holding a medical device firm licence, or the clinical trial site itself, which is exempt from the licence requirement. Foreign sponsors file through one of those.
What to do. If your trial is running, the next amendment or progress report you file goes through the platform. Make sure whoever files for you has a platform account, has your current Chinese summary, and is collecting screening and adverse-event counts in the new format.
3. Notes on recruiting participants (from 21 September)
What changed. The TFDA published Notes on Methods of Recruiting Participants for Medical Device Clinical Trials (115/09/21, FDA器字第1151610205號). They are guidance, issued as a reference for trial sites and their ethics committees. They apply to trials that need TFDA approval and to trials that need only ethics committee review. Recruitment material must be approved by the ethics committee before it is published, and it must show that approval and the version date. It must not:
- name the investigational device or the device company
- stress that the trial is approved
- claim that taking part is safe or better than current treatment
- offer the product free
- create urgency
Referral fees to participants are not allowed. Social media recruitment is not restricted in principle. A retrospective study that pulls patients' electronic records counts as recruitment in the broad sense, and must follow the medical-records and personal-data rules.
Who it affects. Anyone running a trial in Taiwan, and especially a startup planning digital recruitment.
What to do. Strip product and company names from recruitment copy before it goes to the ethics committee.
What did not change, and matters more to a startup
A founder deciding where to run an early study needs the rules that decide whether Taiwan works, not the filing mechanics. They have been in place since May 2021. Few companies outside Taiwan use them.
Some trials need ethics approval only
Taiwan's Medical Devices Act requires authority approval for a device trial unless the Ministry has announced it as no-significant-risk (Art. 37). The announced categories (110/04/27, 衛授食字第1101603684號) are:
- a device already licensed in Taiwan and used within its approved scope
- a device tested on lawfully obtained specimens or data, with results not used for clinical diagnosis
- a device without ionising radiation that sits on the body surface or does not touch it, used to collect data, with results not used for diagnosis
Trials in these categories need only the ethics committee. The TFDA's own Q&A confirms this.
For software and AI this is the important part. TFDA guidance from February 2022 works through AI/ML examples:
- CAD software that reads chest X-rays already taken in routine care, with outputs not used to treat the patient, is no-significant-risk.
- So is a wrist-worn ECG study collecting training data.
- An analysis of de-identified data with no participants is not a device clinical trial at all.
Taiwan's categories are a fixed list, unlike the US, where the sponsor and the IRB decide whether a study is non-significant-risk (21 CFR 812.2(b)). If you cannot tell whether your study fits, you can ask the TFDA for a formal risk determination for NT$20,000.
An approved US IDE gets a simplified procedure
A trial that the US FDA has approved can use a simplified procedure in Taiwan. You file a sworn undertaking that the protocol is identical, the FDA's approval letter and the US IRB approval. This was in the 2021 instructions and is unchanged in the 2026 version. No other country's approval gets this treatment. A US startup with an approved IDE can add a Taiwanese site more cheaply than a European startup with a CE mark can.
A Taiwanese trial can stand in for a home-country approval
This is the provision founders most often miss. To register a Class 2 or 3 device in Taiwan, a foreign manufacturer normally needs a Certificate of Free Sale from its home country, which means a home approval first. Under the registration regulation, a world-first device with no similar product is exempt from that certificate. Instead it files a report of a TFDA on-site inspection of the foreign manufacturer and the report of a clinical trial conducted in Taiwan (Regulations on Licensing and Listing of Medical Devices, Annex 2, item 4(2)5, amended 2023-11-27). Separately, a product that has had government priority support and has been or will be validated in a Taiwanese trial can ask for priority review (Art. 9).
Our reading is that, for a genuinely novel device, Taiwan can be a first market rather than a follow-on, provided the trial runs there. The on-site inspection is not cheap: the fee schedule puts a foreign QMS on-site inspection at NT$600,000. Whether a Taiwanese trial is required is still decided case by case (Annex 2, item 9(2)).
The practical gates
- Someone local has to file. Either a Taiwanese company with a device firm licence or the site itself. Choose this partner as carefully as a future licence holder: in Taiwan they are often the same company.
- Importing the investigational device is a separate application. It is a special approval under the rules for specially approved manufacture and import of specific devices. The device must be made under the QMS regulation and labelled "for clinical trial use only" (GCP Art. 13).
- The principal investigator must qualify. They need five years in clinical practice and 30 hours of trial training in the last six years, including nine hours on device trials and nine on ethics (GCP Art. 27).
- The authority and the ethics committee can review in parallel. The TFDA's Q&A confirms this. The protocol and consent versions that each approves must match.
- Fees are modest. Under the fee schedule as amended 23 February 2023: protocol review NT$50,000, amendment NT$5,000, final report review NT$50,000, import special approval NT$10,000. A draft revision of the schedule was published in June 2026, so check before you budget.
Who actually runs device trials in Taiwan
We counted publicly registered trials with a device intervention and at least one Taiwanese site that started on or after 1 May 2021, when the current device GCP regulation took effect. We matched their company sponsors against our corpus. Figures are as at 19 October 2026.
| Measure | Trials |
|---|---|
| Device trials with a Taiwanese site, started since 1 May 2021 | 624 |
| Led by a hospital, university or other non-company sponsor | 527 (84%) |
| Led by a company, with no drug or biologic arm | 50 |
| Of those 50, Taiwan the only country | 39 |
| Of those 50, led by a foreign company | 12, from 7 companies |
| Foreign company sponsors already holding Taiwanese registrations | 7 of 7 |
Every foreign company that ran a company-led device trial in Taiwan in that period was a multinational already registered there. Eleven of their twelve trials were multi-country studies that added a Taiwanese site. We found no foreign company without a Taiwanese registration sponsoring a device trial there. The other 38 trials came from Taiwan-based companies. In a spot check of five, all five already held Taiwanese registrations under their Chinese names.
Two cautions. Public registration of a trial is not compulsory for every Taiwanese device study. Studies that need only ethics approval are probably under-counted here. The TFDA platform's own public list would be the complete source, and we could not reach it. So the finding is narrower than "foreign startups do not use Taiwan". In public trial records, they have not, and the three provisions above are a reason to ask why.
If your trial is already running
- Confirm your trial is registered on mdctp.fda.gov.tw and that the entry is current. Plan the December 2026 update.
- File your next amendment, progress report or final report on the platform, with the application form and Chinese summary entered online.
- Start collecting screened counts, and AE/SAE counts both by event and by participant per investigator, so the next progress report is not rebuilt by hand.
- Convert attachments to searchable PDF or ODF.
- Have your site's ethics committee re-check any live recruitment advertising against the September notes.
The calendar
- 21 September 2026 (115/09/21): recruitment notes issued
- 1 October 2026 (115/10/01): the platform is designated for trial registration
- 5 October 2026 (115/10/05): the revised application instructions take effect and the 2021 version lapses
- December 2026: the first half-yearly registration update under the new designation
Whether your next study belongs in Taiwan is a cross-market decision. It depends on where your first approval will come from, whether an IDE is coming, and whether a Taiwanese trial could carry you to a Taiwanese licence before your home market. That is the question our market assessments are built to answer.
Sources
- Ministry of Health and Welfare announcement 衛授食字第1151609789號, 30 September 2026 (115/09/30): designation of the Digital Medical Device Clinical Trial Platform, effective 1 October 2026. Published by TFDA on 2 October 2026.
- Ministry of Health and Welfare announcement 衛授食字第1151610689號, 5 October 2026 (115/10/05), with the revised Application Instructions for Medical Device Clinical Trial Protocols. Replaces 衛授食字第1101603667號 (23 April 2021). Published by TFDA on 7 October 2026.
- TFDA announcement FDA器字第1151610205號, 21 September 2026: Notes on Methods of Recruiting Participants for Medical Device Clinical Trials.
- TFDA notice, 2 October 2025: new applications fully electronic from 1 October 2025. TFDA letter FDA器字第1121601869號, 15 March 2023: platform in operation from 1 May 2023.
- Medical Devices Act, Art. 37. Regulations for Good Clinical Practice of Medical Devices, Arts. 4, 7, 13, 27, 58, 67. No-significant-risk categories, 衛授食字第1101603684號 (27 April 2021). TFDA Q&A on the GCP regulation (rev. 7 September 2021). TFDA AI/ML no-significant-risk examples (February 2022).
- Regulations on Licensing and Listing of Medical Devices, Art. 9 and Annex 2 (amended 27 November 2023). Standards for Medical Device Administrative Fees (amended 23 February 2023).