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Safety Alert & Recalls/ Review Reports/ Package Inserts …

    https://www.pmda.go.jp/english/search_index.html
    Recalls (in Japanese) PMDA Alert for Proper Use of Drugs Revisions of PRECAUTIONS Safety information announced by MHLW PMDA Risk Communications MHLW Pharmaceuticals and Medical Devices Safty Information PMDA Medical Safety …

Notifications Related to Safety Measures (Medical …

    https://www.pmda.go.jp/english/safety/info-services/devices/0007.html
    Sep 13, 2022

International Medical Devices Database

    https://medicaldevices.icij.org/events/jpn-nav-single-use-instrument
    Download the data Events Recall of Nav single use instrument According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in …

Japanese medical device recall requirements & procedure for …

    https://elsmar.com/elsmarqualityforum/threads/japanese-medical-device-recall-requirements-procedure-for-foreign-manufacturers.74003/
    Japanese medical device recall requirements & procedure for foreign manufacturers Home Forums Medical Devices, Medical Information Technology, …

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, Labor, and Welfare (MHLW). The PMDA is an …

Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …

The device recall crystal ball - Medical Device Network

    https://www.medicaldevice-network.com/analysis/the-device-recall-crystal-ball/
    In 2020, Medtronic recalled over 300,000 of its MiniMed 600 series insulin pumps after discovering a fault that could give the user the wrong dose of medication. …

GE HealthCare Recalls Nuclear Medicine 600/800 …

    https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients
    See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; Date …

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 …

Authorization of Medical Devices in Japan - Johner Institute

    https://www.johner-institute.com/articles/regulatory-affairs/and-more/authorization-of-medical-devices-in-japan/
    As a foreign manufacturer, you do not have to demonstrate “home country approval” to have a medical device authorized in Japan. However, an ISO-13485 …



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