Points to Consider for the Preparation of Applications for Marketing Approval of Remanufactured Single-use Medical Devices (Provisional Translation January 2019)

“…We have prepared detailed instructions concerning the handling of applications for marketing approval of reprocessed single-use medical devices (R-SUDs) as provided below. We request your cooperation in circulating the information contained in this Notification to marketing authorization holders (MAHs) of medical devices, etc. under your supervision.”