www.mhlw.go.jp/stf/newpage_06675.html
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This page documents the 17th regular opinion exchange meeting on medical device and in vitro diagnostic approval reviews held on July 29, 2019, at PMDA headquarters. The Ministry of Health, Labour and Welfare presented initiatives to accelerate access to innovative medical devices, including the Sakigake Designation System and Conditional Early Approval System. Director General Tarumi emphasized the importance of advanced technologies like genomic medicine and AI in drug development. PMDA's President Fujiwara committed to providing high-quality reviews proportional to examination fees. The meeting aimed to gather stakeholder opinions on regulatory strategies for medical devices and diagnostics.
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