MASAMUNE Ken    Department   Research Institutes and Facilities, Research Institutes and Facilities    Position   Professor
Article types	Review article
Language	Japanese
Peer review	Non peer reviewed
Title	Research to compare regulations related to post-marketing data collection of medical devices among Japan, the U.S.A., and the EU and to investigate performance of Survey on the Results of Usage system
Domestic / Foregin	Domestic
Volume, Issue, Page	pp.1-93
Total page number	93
Publication date	2023/03/31
Summary	Post-marketing data collection of medical devices is important for proper use of medical devices and safety measures. In Japan, the relevant regulations have been changing. For example, the Pharmaceutical Affairs Law was revised to Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices in 2014. In the European Union, introduction of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is ongoing. In this way, the related regulations are being changed in response to changes in the technology and environment surrounding medical devices. In this research, we conducted a survey on the latest regulations related to post-marketing data collection of medical devices in Japan, the U.S.A., and the EU (and the UK), a survey on the performance of the Survey on the Results of Usage system in Japan and the Post-Approval Studies (PAS) system in the U.S.A. We also conducted interviews on the operation of the related regulations. These survies and interviews aimed at contributing to further measures related to postmarketing data collection and discussions on international harmonization. As a result, it was confirmed that a malfunction reporting system has been established in each country/region that specifies the necessity and due date of reporting depending on the details of malfunctions, and that a system requiring companies to conduct post-marketing studies has been introduced. We believe that the systems that require these studies have/may be different in operation. Also, it should be noted that only the EU has a mechanism for requesting Periodic Safety Update Reports (PSURs) according to the class of medical devices.