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Ministry of Health, Labour and Welfare: Pharmaceuticals …

    https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/index.html
    Registration opens for EMA/FDA/MHLW-PMDA Orphan Product Designation Workshop. Overview of Orphan Drug/Medical Device Designation System. Information for those …

MHLW Pharmaceuticals and Medical Devices Safety …

    https://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0002.html
    MHLW Pharmaceuticals and Medical Devices Safety Information. This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information …

Pharmaceuticals and Medical Devices Agency - Pmda

    https://www.pmda.go.jp/english/
    February 15, 2023 PMDA-ATC Seminar Schedule for FY2023 has been released. February 14, 2023 MHLW Pharmaceuticals and Medical Devices Safety Information No.398 …

MDSAP Revision of MHLW MO169, Japan medical …

    https://www.bsigroup.com/en-US/medical-devices/News-center/E-updates/2022-news/mdsap-revision-of-mhlw-mo169/
    MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003. …

Welcome to Ministry of Health, Labour and Welfare

    https://www.mhlw.go.jp/english/
    Health Insurance Pharmaceuticals and Medical Devices Data-based Health Management Initiatives Children and Childrearing Promotion of Balancing Work and Family Health and …

Revision of Japanese Medical Device QMS requirements

    https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html
    The Japanese medical device Quality Management System requirements are stipulated in MHLW Ministerial Ordinance No. 169 (2004) titled "the Ministerial Ordinance on …

MHLW Pharmaceuticals and Medical Devices Safety …

    https://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0019.html
    MHLW Pharmaceuticals and Medical Devices Safety Information; PMDA Alert for Proper Use of Drugs; ...

Ministry of Health, Labour and Welfare: Information for …

    https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/180822-01.html
    A call has been put out for requests for the development of medical devices and in-vitro diagnostics whose use has to date been approved in Western countries, etc. but not in Japan (hereafter, medical devices, …



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