How do the MHLW and PMDA collaborate in the oversight of medical devices in Japan?

The MHLW and PMDA collaborate by setting regulatory standards, conducting pre-market evaluations, and post-market surveillance of medical devices. MHLW formulates policies and regulations, while the PMDA handles dossier reviews, scientific reviews, inspections, and adverse event monitoring, ensuring safety, efficacy, and quality of medical devices in Japan.

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