MedTech Current regulatory intelligence and device recall publications for Japan.
PMDA has made its September draft review points for generative AI medical devices available in English. The draft discusses clinical scope, performance testing, supplier dependencies and life-cycle risk management; the translation introduces no newly effective requirements.
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.
PMDA has updated the currently available timing for face-to-face consultations conducted by its Programmed Medical Device Review Office, with scheduling now shown as November 2026 and later. The update is a consultation-capacity notice rather than a change to the statutory or standard review timeline for SaMD approvals.
Japan is adding MCCP, LC-PFCA and related substances to its Class I Specified Chemical Substances regime, with related import restrictions taking full effect on 22 November 2026. Medical device teams should first confirm product scope and the PMD Act/CSCL interface before treating finished devices as import-banned products.