Marketing authorization holders carry the Japanese post-market safety duties; persons operating Registered Manufacturing Sites do not report to the regulator directly but must pass to the marketing authorization holder, promptly, the events defined in the Ordinance for Enforcement of the PMD Act Art 228-20 (MO169 Art 55-3): serious malfunctions that may have caused health damage (domestic and foreign) and unlabelled non-serious ones (domestic); serious and domestic unlabelled adverse reactions caused by malfunction; actions taken abroad on equivalent devices to prevent public health hazards (suspension of manufacture, import or sale, recall, withdrawal); and study reports showing possible cancer, serious illness, injury or death from malfunction or infection, significant changes in occurrence rates, or lower effectiveness than approved.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.