MedTech Current regulatory intelligence and device recall publications for China.
Five Chinese IVD guidance technical document projects cover POCT personnel, public health emergencies and CTC pre-examination processes. All remain at the drafting stage; the POCT project is intended to replace GB/Z 43281-2023.
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.
A reproduced CMDE neurostimulator draft details MRI configuration coverage, battery management and remote-programming evidence. Field strength alone does not justify test coverage, and battery evidence includes the interval from warning to loss of power. The copy remains unauthenticated against the official original.
A reproduced NMPA consultation draft combines general GMP and software provisions in a graded inspection checklist. Its clauses distinguish critical and major controls and specify lifecycle traceability and cloud responsibilities; the current copy remains unauthenticated against the official original.
NMPA is consulting on a pathway for eligible Class II and III devices with valid domestic registration certificates to be registered by a related applicant in another province. The draft would allow reuse of specified registration materials while retaining testing and quality-system requirements; comments are due October 30, 2026.
NMPA is consulting on an IVD reagent GMP inspection draft that integrates the general GMP and IVD appendix into 212 inspection items across three risk levels. Comments are due October 10, 2026; the same notice also covers a separate custom-made denture draft.
NMPA has opened comment on revised GMP inspection guides for sterile and implantable medical devices. The drafts combine the revised general GMP with the relevant special appendices and classify findings as critical, major, or general; comments are due October 8, 2026.