Topic archive
MedTech Current publications and recall entries tagged Clinical & Evidence.
China's 2026 HCV genotyping guidance replaces the earlier overall clinical sample-size wording with recommendations for individual genotypes and subtypes. Analytical coverage, comparator selection and labeling remain important to substantiating the claimed detection range.
China's 2026 HER2 gene amplification guidance replaces fixed clinical sample counts with a statistical estimation framework for positive and negative agreement. Separate designs for each indication, drug-linked comparators and borderline-sample evaluation remain central to the evidence package.
The non-binding MHLW guidance distinguishes non-clinical equivalence evidence from the human oral clinical evaluation generally needed for implant-related use, while preserving justified exceptions.
The new hub brings together existing guidance and publications on real-world evidence. Device developers should distinguish the hub’s launch from the dates, status and scope of its linked resources.
South Korea's MFDS has issued a new guide for evaluating the clinical accuracy of non-invasive automated blood pressure monitors, outlining auscultatory and invasive reference methods, subject and test-design requirements, analysis methods, and considerations for pregnant populations in alignment with ISO 81060-2.
The Philippine FDA is consulting on a draft Administrative Order that would establish a more complete regulatory framework for medical device clinical investigations and IVD clinical performance studies, including sponsor and CRO licensing, ethics review, FDA study approvals, safety reporting, and inspections. The draft remains under consultation and may change before final issuance.