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ASEAN Medical Device Committee (AMDC) - HSA

    https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/amdc
    The ASEAN Medical Device Committee (AMDC) was formed in 2014 to coordinate the implementation of the ASEAN Medical Device Directive (AMDD), an …

ASEAN Medical Device Regulatory Integration

    https://www.pacificbridgemedical.com/publication/asean-medical-device-regulatory-integration/
    This article describes the details of ASEAN’s ongoing project to create a single Southeast Asian regulatory regime for medical devices. ASEAN Medical Device …

Standard and Conformance - ASEAN Main Portal

    https://asean.org/our-communities/economic-community/standard-and-conformance/
    1. ASEAN Agreement on Medical Device Directive (2014) Interpretative Notes for AMDD; Annex 1: Essential Principles of Safety and Performance of Medical Devices; Annex 2: …

ASEAN MEDICAL DEVICE DIRECTIVE - Asia Actual

    https://asiaactual.com/wp-content/uploads/2020/11/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
    HAVING regard to the objectives of harmonised medical device regulations, common technical documents and the progress made in implementation. …

ASEAN Medical Device Directive

    https://asean.org/wp-content/uploads/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
    ASEAN Medical Device Directive

ASEAN Medical Device & Pharmaceutical Regulations

    https://www.pacificbridgemedical.com/regulation/asean-medical-device-pharmaceutical-regulations/
    ASEAN Medical Device and Pharmaceutical Regulations. The Association of Southeast Asian Nations (ASEAN), which is comprised of the countries Indonesia, Malaysia, Philippines, Singapore, Thailand, …

Regulations of medical devices in ASEAN countries

    https://www.researchgate.net/publication/358017363_Regulations_of_medical_devices_in_ASEAN_countries
    Device Regulatory Integration: Countries Working to Modernize Healthcare Industry May Ease Medical Device Entry into Southeast Asian market G Ames M John …

ASEAN Medical Device Directive Implementation: Current …

    https://www.qualtechs.com/en-gb/article/164
    May 11, 2018. The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical …

The Drug Regulatory Landscape in the ASEAN Region

    https://www.raps.org/news-and-articles/news-articles/2018/1/the-drug-regulatory-landscape-in-the-asean-region
    The ASEAN Pharmaceutical Product Working Group (PPWG) was established by the ASEAN Consultative Committee for Standards and Quality (ACCSQ) …

ASEAN medical device regulatory integration: countries working …

    https://www.thefreelibrary.com/ASEAN+medical+device+regulatory+integration%3a+countries+working+to...-a0196244087
    Jan 1, 2009



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