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Pharmaceuticals and Medical Devices Agency - Pmda

    https://www.pmda.go.jp/english/
    February 14, 2023 MHLW Pharmaceuticals and Medical Devices Safety Information No.398; February 14, 2023 Revisions of PRECAUTIONS:Exenatide, etc. posted; February 9, 2023 Notifications Related to Safety Measures (In-vitro Diagnostics) : Consultation …

Regulatory Information | Pharmaceuticals and Medical …

    https://www.pmda.go.jp/english/review-services/regulatory-info/0002.html
    Revision of Japanese Medical Device QMS requirements; Procedures for Developing Post-marketing Study Plan; Principles for the Evaluation of Vaccines Against the Novel …

Japan Medical Devices Regulatory Environment

    https://www.trade.gov/market-intelligence/japan-medical-devices-regulatory-environment
    Japan’s Pharmaceutical and Medical Devices Law (PMD Law) improves the regulatory environment for medical devices. Japan has been taking steps to …

Revision of Japanese Medical Device QMS requirements

    https://www.pmda.go.jp/english/review-services/regulatory-info/0004.html

    An Overview of Medical Device Regulations in Japan

      https://www.regdesk.co/an-overview-of-medical-device-regulations-in-japan/
      In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the …

    Ministry of Health, Labour and Welfare: Pharmaceuticals …

      https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/index.html
      APEC endorsed Japan’s PMDA as a pilot Training Center for Medical Devices Regulation (March 18, 2019) To protect people from drug abuse For Travelers Illicit Drugs …

    Japan Medical Device & Pharmaceutical Regulations

      https://www.pacificbridgemedical.com/regulation/japan-medical-device-pharmaceutical-regulations/
      Current Japan PMDA regulations are laid out in the Pharmaceuticals and Medical Devices Act (PMD Act), also known as the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, …

    Medical Device Registration and Approval in Japan - Emergo

      https://www.emergobyul.com/services/medical-device-registration-and-approval-japan
      Japan's medical device regulation and approval process Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals …

    Japan - New guidelines from Japanese regulators cover medical …

      https://www.ris.world/japan-new-guidelines-from-japanese-regulators-cover-medical-device-cybersecurity-remanufactured-devices-and-mdsap-reports/
      Japan’s MHLW updates medical device program display code and labeling laws Japan’s Ministry of Health, Labor and Welfare (MHLW) has published several new …



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