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Medical Devices - Guidance, Law & Regulations - Food …

    https://www.fda.gov.tw/eng/law.aspx?cid=5063
    Regulations for Medical Device Recalls. 2021-05-01. 7. Regulations for Management of Medical Device Safety Surveillance. 2021-05-01. 8. Regulations for Management of Medical Devices Technicians. 2021-05-01. 9. Regulations of Medical …

Medical Device Vigilance Reporting in Taiwan - Emergo

    https://www.emergobyul.com/services/medical-device-vigilance-reporting-taiwan
    The Taiwan Food and Drug Administration (TFDA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event …

Regulations for Reporting Serious Adverse Events of …

    https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030124
    Medical device license holders or firms that have completed the listing and medical institutions shall keep the contents of the reporting of serious adverse events …

Taiwan Draft Guidance on Adverse Event Reporting

    https://www.regdesk.co/taiwan-fda-adverse-event-reporting/
    Taiwan Draft Guidance on Adverse Event Reporting. The Taiwan Food and Drug Administration (FDA) has published several …

TAIWAN: implementation of the new Medical Devices Act on 1 …

    https://www.thema-med.com/en/2021/05/26/taiwan-implementation-new-medical-devices-act-1-may-2021/
    Serious adverse events reporting; Medical Devices Recalls; Further measures for the surveillance of safety aspects. Lastly, the Medical Devices Act outlines …

Food and Drug Administration, Department of Health

    https://www.fda.gov.tw/eng/
    2020 Taiwan FDA and Thai FDA Medical Devices Virtual Meeting. 2021 Taiwan FDA and Australia TGA Medical Devices Virtual Meeting. The Agreement of Cooperation Between …

Taiwan agent representation for medical device companies

    https://www.emergobyul.com/services/taiwan-agent-representation-medical-device-companies
    Oversee Serious Adverse Event (SAE) reporting for your device, if necessary; Assist with maintaining your QSD Certificate and device registration; Once your product has …

TAIWAN:New Draft on “Regulations for Reporting …

    https://www.qualtechs.com/en-gb/taiwannew-draft-on-regulations-for-reporting-serious-adverse-events-of-medical-devices
    Reporting of adverse reactions of medicament or medical devices provides valuable information for TFDA, manufacturers, medical professionals and …

Taiwan Medical Device Adverse Event Reporting - Elsmar Cove …

    https://elsmar.com/elsmarqualityforum/threads/taiwan-medical-device-adverse-event-reporting.45408/
    Taiwan accepts GHTF documents and hence you can adopt the practise as per GHTF Document on Adverse Event Reporting, SG2 N21R8 that I have attached. …

Regulations for Reporting Serious Adverse Events of …

    https://law.moj.gov.tw/ENG/LawClass/LawSearchCNKey.aspx?BTNType=CON&pcode=L0030124
    Regulations for Reporting Serious Adverse Events of Medical Devices - Content Search News Law Convention Justices of the Constitutional Court Related Websites ::: …



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