Topic archive
MedTech Current publications and recall entries tagged Quality System.
Mexico's updated blood standard requires HIV, HBV and HCV nucleic acid testing and extends irregular antibody screening to all donors. It provides 180 calendar days before entry into force and a further 180 days for the two testing requirements.
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 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.
OSHA has issued a preliminary finding on Intertek’s application to add UL 3100 for automated mobile platforms to its NRTL scope. The proposed expansion remains subject to a final decision.
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.
MFDS has issued guidance on responding to MDSAP-related review scenarios for medical devices in Korea. For manufacturers and Korean import-license holders that already operate under MDSAP, the guidance is relevant to how audit reports and CAPA records may be used to support or simplify Korea-facing inspection and GMP processes.
FDA is seeking public comment on extending the existing voluntary information collection used for allegations of regulatory misconduct involving medical devices and CDRH-regulated electronic products. The notice does not create new enforcement standards; it continues the existing reporting channel, under which anyone may submit allegations and may provide supporting information anonymously or with contact details.