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Vietnam Medical Device Registration - Asia …

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

Vietnam Medical Device Registration - International …

    https://www.trade.gov/market-intelligence/vietnam-medical-device-registration
    Vietnam’s Ministry of Health is responsible for the implementation of legislative documents, strategies, policies and plans regarding medical devices. In 2019, the Vietnam Medical …

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 …

Vietnam Medical Device Registration - DMEHW …

    https://arazygroup.com/medical-device-registration-vietnam/
    AUTHORIZED REPRESENTATIVE: A foreign manufacturer must appoint an authorized representative (AR) to register their medical device in Vietnam. …

Vietnam issues new regulation for medical device management

    https://andamanmed.com/vietnam-issues-new-regulation-for-medical-device-management/
    On 8 November 2021, the Vietnam government signed Decree 98/2021/ND-CP regulating the management of Medical Devices. The new decree enters into force on …

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 …

VietNam IVD Product Registration and …

    https://asiaactual.com/vietnam/ivd-device-registration/
    Import License applications involve mostly administrative documents, with a technical summary, and clinical data for devices related to the heart and central nervous system. …

Vietnam MoH registration - Qualtech: Medical Device …

    https://www.qualtechs.com/en-gb/vietnam_registration
    As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical …

Vietnam Medical Device Regulations | RegDesk

    https://www.regdesk.co/resource-library/vietnam/
    The validity duration of an import license is one year; Application for importation: importer must provide a certificate of free sale or confirmation allowing circulation from the: USA or …

New Rules for Vietnam’s Medical Devices …

    https://www.vietnam-briefing.com/news/vietnams-medical-devices-industry-new-law.html/
    A key concern is with respect to Vietnam’s standards when defining a Class A medical device – which may not be considered as such in other countries. Flexible …



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