1. Pharmaceuticals and Medical Devices Agency, Descriptive pamphlet. https://www.pmda.go.jp/files/000219906.pdf(in Japanese). Accessed June17, 2020.
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4. Ministry of Health, Labour and Welfare, Pharmaceuticals and medical devices. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/index.html(in Japanese). Accessed June17, 2020.
5. Ministry of Health, Labour and Welfare, Study Group on the Early Introduction of Medical Devices, etc. with High Medical Need. https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000095066.html(in Japanese). Accessed June17, 2020.