QT Analysis: Taiwan TFDA Upgrades IVD Regulatory Requirements for CRP and AST Systems – How Should Companies Adjust Their Market Strategy? – September/October 2026

• 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.

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Qualtech Webinar: Navigating Medical Device Studies in the US - Regulatory Strategy, Study Design, and Subject Management - March 2026

• 2026-03-04 08:36:52

Join Qualtech's free webinar, "Medical Device Studies in the US: Regulatory Requirements, Study Design, and Best Practices in Subject Management" on March 26, 2026. This complimentary session is designed to provide clear and practical insights into US regulatory expectations, study design considerations, and effective subject management strategies.

Take advantage of this opportunity to strengthen your understanding of US medical device study requirements

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