Japan formally joins international pilot on single audit for medical devices
This article was originally published in SRA
Executive Summary
Japan's health ministry and healthcare products regulator agency have formally joined the pilot phase of the international medical device single audit program (MDSAP)1. Until now, the country's Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency have only been involved as observers and active participants in MDSAP's Regulatory Authority Council (the MDSAP's governing board) and its subject matter expert groups2.