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Standards for Medical Devices in Japan - Pmda

    https://www.std.pmda.go.jp/stdDB/index_en.html
    [2023/01/06] <MD>One Japanese Medical Device Nomenclature (JMDN) is established. [2022/12/15] <MD>One Japanese Medical Device Nomenclature (JMDN) is established. [2022/11/29] <IVD> New contents for In Vitro Diagnostics (English edition …

English edition of Japanese Medical Device …

    https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/JMDN_en.pdf
    Japanese Medical Device Nomenclature (JMDN) Definition JMDN Code Classificati on Rule QMS Requirements Designated MDs requiring maintenance Reusable ultrasound probe …

Japan's Classification of Medical Devices|Japan MDC, …

    https://www.j-mdc.com/en/product/classification.php
    Japan's Classification of Medical Devices. For medical devices manufactured, imported and/or ...

Medical Device Classification and JMDN …

    https://www.emergobyul.com/services/medical-device-classification-consulting-and-japan-jmdn-code-research
    How medical devices are classified in Japan General – CLASS I (low risk) Specified Controlled – CLASS II (low/medium risk) Controlled – CLASS II (medium …

JMDN (Japanese Medical Device Nomenclature) codes list needed

    https://elsmar.com/elsmarqualityforum/threads/jmdn-japanese-medical-device-nomenclature-codes-list-needed.30729/
    Japanese medical device recall requirements & procedure for foreign manufacturers: Japan Medical Device Regulations: 4: Oct 4, 2018: M: Are English …

An Overview of Medical Device Regulations …

    https://www.regdesk.co/an-overview-of-medical-device-regulations-in-japan/
    Contents 1. Classification and Product Registration 2. Foreign Manufacturer Registration (FMR) 3. Device Reimbursement The PMDA uses the Japan …

GMDN Agency

    https://www.gmdnagency.org/
    The GMDN provides terms which name and group all medical device products and can be used to exchange medical device information and support patient …

mhlw.go.jp

    https://www.mhlw.go.jp/file/04-Houdouhappyou-11123000-Iyakushokuhinkyoku-Shinsakanrika/regulation_medicaldevices.pdf
    mhlw.go.jp

Nomenclature of medical devices - World Health …

    https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/nomenclature
    Classification, coding and nomenclature characteristics The following are required: a transparent methodology and processes; a transparent mechanism for regular updates …

Nomenclature of medical devices - omcmedical.com

    https://omcmedical.com/nomenclature-of-medical-devices/
    Universal Medical Device Nomenclature System or UMDNS was developed by the Emergency Care Research Institute (ECRI). Many nations have adopted this …



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