• 2026-06-26 06:18:15

On 4 June 2026, the Taiwan Food and Drug Administration (TFDA) announced the Good Machine Learning Practice (GMLP): Development and Management Principles for Artificial Intelligence Medical Devices, providing a lifecycle management framework for AI-enabled medical devices. The guidance outlines 10 key principles covering product design, data quality, clinical evaluation, human oversight, cybersecurity, and post-market monitoring, while further aligning Taiwan's regulatory expectations with international AI medical device frameworks.

• 2023-10-20 06:31:20

Recently, TFDA has announced an amendment to the classifications of medical devices. The scopes and identifications of several medical device classifications have been updated to provide more specific and clearer instructions. Among these, the risk level of 3 classifications has been re-determined and there are 11 new additional classifications.

• 2022-03-25 11:56:37

Recently, TFDA has announced an update in the Quality Management System (QMS) application required documents for manufacturers in the US, Puerto Rico, or Guam. Considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit report issued under MDSAP could be provided instead.

• 2021-05-22 07:03:29

As TFDA's Medical Device Act has come into force on May 1st, 2021, supporting measures and announcements following the Act have sprung up like mushrooms recently. This article provides a quick guide and introduction to each corresponding measure.

• 2020-11-27 01:49:09

The previous regulation: “Products under classification I.0007 Hyaluronic Acid Implants required to conduct PSUR” is ceased since July 23rd, 2020. TFDA has re-evaluated the product safety and decided that each medical device under this classification may be reviewed individually for the necessity for conducting Periodic Safety Update Report (PSUR).

• 2020-10-15 05:09:36

FAQs for TFDA Good Distribution Practice (GDP)

• 2020-08-13 02:35:55

TFDA現在正在收集有關起草“醫療器材檢驗委任或委託作業辦法”的意見和建議（截止日期：2020/09/07）。 本文詳細介紹了即將到來的法規。

• 2020-06-16 08:03:29

TFDA現在正在收集有關“醫療器材品質管理系統檢查及製造許可核發辦法”草案的意見和建議。 本文提供了當前法規和即將頒布的法規之間的比較。

• 2020-06-16 08:03:29

TFDA現在正在收集有關“醫療器材優良臨床試驗管理辦法”草案的意見和建議。 本文提供了當前法規和即將頒布的法規之間的比較。

• 2020-06-16 05:48:04

台灣TFDA發布軟性（親水）隱形眼鏡產品的特定臨床前測試指南。 該指南為（1）產品說明和規格以及（2）安全和性能數據提供了明確的標準。 臨床前的整體測試數據應包括檢查規範、方法、原始記錄和結果。