• 2026-10-27 05:30:31

Taiwan's Food and Drug Administration (TFDA) released new guidance in August and September 2026 for C-Reactive Protein (CRP) assays and Antimicrobial Susceptibility Testing (AST) systems, two Class II in vitro diagnostic (IVD) device categories. The updates require CRM470 calibration traceability and additional clinical data for hsCRP cardiovascular risk claims, as well as multi-center accuracy studies for AST systems. This analysis reviews the key changes, their impact on registration timelines and market competition, and the value of an early technical documentation gap analysis.

• 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).

• 2020-08-13 02:35:55

TFDA is now collecting comments and suggestions for the drafting of “Regulations Governing Delegation or Commission of Medical Devices Test” (collecting deadline: 2020/09/07). This article presents a closer look of this upcoming regulation.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations of the Medical Device Quality Management System. This article provides a comparison between the current and the upcoming regulation.

• 2020-06-16 08:03:29

TFDA is now collecting comments and suggestions for the draft of “Regulations on Good Clinical Practice for Medical Devices”. This article provides a comparison between the current specification and the upcoming regulation.

• 2020-06-16 05:36:31

This is a specific pre-clinical testing guidance for products classified under Powered wheelchair in Taiwan. The guidance provided a clear standard of (1) product description and specification, and (2) safety and performance data. The overall pre-clinical test data should include inspection specifications, methods, original records, and results.