単回使用医療機器の「再製造」に関する制度の対象品目を初めて承認しました
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単回使用医療機器の「再製造」に関する制度の対象品目を初めて承認しました
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This page announces that Japan's Ministry of Health, Labour and Welfare has approved the first medical device under its remanufacturing system for single-use medical devices. The system, established in 2017, allows manufacturers to collect, disassemble, clean, replace parts, reassemble, and sterilize used single-use medical devices for reuse. On August 30, 2019, "Remanufactured Lasso 2515" by Japan Stryker Corporation was approved as the first target device. This cardiac electrophysiology and temporary pacing device has been used in the US and Europe, with cleanliness and safety confirmed by PMDA.
