Taiwan TFDA Updates Electronic Clinical Trial Submission Guidance

Taiwan has designated the Digital Medical Device Clinical Trial Platform (數位化醫療器材臨床試驗平台, mdctp.fda.gov.tw) for sponsors' trial-registry entries under Article 7 of the Regulations for Good Clinical Practice of Medical Devices (醫療器材優良臨床試驗管理辦法) from 1 October 2026. Revised application guidelines effective 5 October 2026 replace the 2021 paper-and-optical-disc instructions with an electronic submission workflow and updated forms for initial applications, amendments, status reports and final reports.

The 5 October announcement expressly says that electronic submission had already been adopted. It formalizes that channel in the revised guidelines; it does not establish 5 October as the platform's launch date or the first day electronic filing became available.

Two-Part Regulatory Action and Effective Dates

1. Mandatory GCP Article 7 Sponsor Data Logging (衛授食字第1151609789號, effective 1 October 2026): Issued on 30 September 2026 and published on 2 October 2026 (official announcement PDF), this announcement designates https://mdctp.fda.gov.tw as the central competent authority's official webpage under Article 7 of the Regulations for Good Clinical Practice of Medical Devices. Under Article 7, clinical trial sponsors (試驗委託者) must log 12 categories of trial information on the designated platform:
   • Initial registration: Within 30 days after clinical trial approval under Article 4, Paragraph 1 (logging the clinical trial institution name, sponsor name, principal investigator name, trial title, approval document number, approval date, trial objective, subject inclusion and exclusion criteria, number of subjects, investigational device name, clinical trial phase, and other required items).
   • Amendment updates: Within 30 days after approval of any clinical trial protocol amendment.
   • Periodic updates during trial execution: Semiannually in June and December of each year while the clinical trial is ongoing.
2. Revised Application Guidelines for Medical Device Clinical Trial Protocols (衛授食字第1151610689號, effective 5 October 2026): Issued on 5 October 2026 under Article 165 of the Administrative Procedure Act and published on 7 October 2026 (official announcement PDF; 24-page revised guideline PDF), this announcement brings the revised 醫療器材臨床試驗計畫案申請須知 into force on 5 October 2026 and states that the prior 23 April 2021 guideline (衛授食字第1101603667號) no longer applies. The revised application guidelines are an administrative guideline issued under Article 165; the sponsor's Article 7 registration duties derive from the separate GCP regulations.

Key Changes in the 5 October 2026 Revised Application Guidelines

A section-by-section and page-by-page comparison between the superseded 1 May 2021 guideline PDF and the 5 October 2026 revised guideline PDF shows five operational changes for sponsors, contract research organizations (CROs), and clinical trial institutions:

Updates to Appendices 1, 7, 9, and 11

In addition to restructuring the submission workflow in Sections I–VII, the 5 October 2026 guideline updates four appendices:

• Appendix 1 (Application Form, page 4): Clarifies in the sequential checkbox instruction (★請依序勾選 1–3 點) that Item 2 (Simplified procedure / Appeal) need not be checked if not applicable (第2點如不適用則無需勾選).
• Appendix 7 (Preclinical Data Reference Standards, page 18): Updates Item 7 from 品質系統 (Quality system) — GMP、ISO 13485 to 品質管理系統 (Quality management system) — QMS、ISO 13485, and updates Item 9 (Particular requirements) from ISO/TR 16142 to ISO 16142-1、ISO 16142-2.
• Appendix 9 (Trial Status Report Template, page 20): Adds a dedicated header field for the ** current number of screened subjects** (目前篩選人數：___人) alongside planned enrolled subjects (預計納入人數) and current enrolled subjects (目前納入人數).
• Appendix 11 (Trial Site Enrollment Summary Table, page 24): Clarifies 受託研究機構（若有） (CRO, if any), inserts a new Principal Investigator (試驗主持人) column next to the trial institution column, and splits the previously combined adverse event columns (AE 發生件數 (x件/x人) and SAE 發生件數 (x件/x人)) into four distinct numeric columns: AE event count (AE 發生件數), AE subject count (AE 發生人數), SAE event count (SAE 發生件數), and SAE subject count (SAE 發生人數).

Unchanged core provisions include the Simplified Procedure (Section III) for clinical trials already approved by the US FDA. Applicants must still provide the initial application dossier plus the Appendix 8 affidavit bearing the required organizational seals, the US FDA approval letter and the US IRB approval letter. The simplified procedure applies after TFDA confirmation; protocol amendments also require TFDA approval before implementation. Investigational Device Importation (Section VII) still requires a separate application under the Regulations for Special Approval of Manufacturing or Importing Specific Medical Devices (特定醫療器材專案核准製造及輸入辦法).

Pure Global analysis: Sponsors and CROs should map each submission to the correct online form, retain the required signatures, and prepare searchable PDF or ODF attachments. Check that trial data systems can supply site-level screening counts and separate adverse event (AE) and serious adverse event (SAE) event and subject totals for the expanded Appendix 11. Maintain two distinct schedules: Article 7 registration updates after approval and in June/December, and trial status reports at the times specified in the approval letter under Section V. Sharing a platform does not make these the same filing or establish that Appendix 11 must accompany every Article 7 update. The Taiwan market guide provides the wider device-registration context.