Japan stresses importance of device reporting rules:
This article was originally published in Clinica
Japan's Pharmaceutical and Medical Safety Bureau (PMSB) has sent out a reminder to prefectural health authorities stressing their responsibilities under the medical device reporting regulations. The reminder was prompted by a number of cases in which companies which import and distribute pacemakers and antiseptic catheters failed to report product malfunctions and cases of infection, reports Pharma Japan. Japan amended its Pharmaceutical Affairs Law last year to strengthen post-marketing safety measures.