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Medical Device Registration in Vietnam

    https://asiaactual.com/vietnam/medical-device-registration/
    Registration requirements for medical devices in Vietnam are currently in a state of transition. New rules governing …

Vietnam Medical Device Registration - International …

    https://www.trade.gov/market-intelligence/vietnam-medical-device-registration
    On May 15, 2016, the Government of Vietnam issued Decree 36/2016/ND-CP, regulating the management of medical equipment which included the classification of medical …

Vietnam issues new regulation for medical device management

    https://andamanmed.com/vietnam-issues-new-regulation-for-medical-device-management/
    Dec 1, 2021

Vietnam Medical Device Registration

    https://andamanmed.com/regulatory-services/medical-device-registration/vietnam/
    Various documentation, both legal and technical, is required to register a medical device in Vietnam. Legal documents include: Free sale certificate, Letter of authorization, ISO 13485 certificate. Technical …

Vietnam Medical Device Registration - DMEHW …

    https://arazygroup.com/medical-device-registration-vietnam/
    Import License (registration for devices under Circular 30): 1 – 3 months. Product registration (regular pathway): 10-12 months. Product registration (quick …

Medical Device and IVD Registration and Approval …

    https://www.emergobyul.com/services/medical-device-and-ivd-registration-and-approval-vietnam
    As of January 1, 2022, regulated medical devices and IVDs can only be marketed in Vietnam if they have a Marketing Authorization Code (MAC). The pathway to obtain a MAC is based on the classification …

Medical Device registration in Vietnam

    https://cmsmedtech.com/medical-device-registration-in-vietnam/
    Updated: 20th July 2020 Medical Device Registration in Vietnam There are currently 2 main regulations (call “Circular”) in place for medical device registration in Vietnam. New Regulation …

Vietnam: New Decree on management of medical devices

    https://www.globalcompliancenews.com/2022/01/19/vietnam-new-decree-on-management-of-medical-devices-07012022/
    National Medical Products Administration (NMPA) – China, Ministry of Food & Drug Safety (MFDS) – Korea Other organizations that grant market authorization …

Medical Device Registration in Vietnam - omcmedical.com

    https://omcmedical.com/medical-device-registration-in-vietnam/
    Medical Device Registration in Vietnam - omcmedical.com Ministry of Health Ministry of Health Regulatory Authority Department of Medical Equipment and Construction (DMEC) …

Vietnam Medical Device Regulations | RegDesk

    https://www.regdesk.co/resource-library/vietnam/
    Appoint a local authorized representative in Vietnam Submit application for importation. This includes: description of purpose for importation, quality certificate, and Certificate of Free …



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