Japan, Ministry of Health, Labour and Welfare:

Japan, Ministry of Health, Labour and Welfare:

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.”

https://www.pmda.go.jp/files/000227842.pdf

By |2019-09-12T16:41:49+00:00January 1st, 2019|Global Regulatory Resource|0 Comments