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Medical Device Regulatory News in Asia | Asia Actual

    https://asiaactual.com/blog/
    Thai FDA Issues Guidance on Specialist Review Selection Criteria. Get the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and …

Medical Devices and Diagnostics in Asia Pacific

    https://www.iqvia.com/-/media/library/white-papers/medical-devices-and-diagnostics-in-asia-pacific.pdf
    while protecting patients. The ASEAN Medical Device Directive (AMDD) is designed to allow easier access for medical device companies to serve the 10-nation ASEAN regional …

ASEAN Medical Device & Pharmaceutical …

    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, …

What's New in Line for the ASEAN Medical Device Regulations in …

    https://www.qualtechs.com/en-gb/what’s-new-in-line-for-the-asean-medical-device-regulations-in-2022-–-november-2021
    Medical Devices (Establishment Duties and Obligations) Regulations 2019 Starting from July 1, 2022, MDA will effectively enforce the Medical Devices …

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 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. HAVE …

Asia Medical Device Consulting, China, Japan, Korea, etc.

    https://www.pacificbridgemedical.com/regulatory-services/medical-device/regulatory-strategy/
    There are several key factors that should be considered when developing a regulatory strategy for your medical device product in Asia: Does your regulatory strategy include …

The Essential List of Regulatory Authorities …

    https://www.raps.org/regulatory-focus/news-articles/2015/4/the-essential-list-of-regulatory-authorities-in-asia
    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website (s) for each country’s …

Thailand Medical Device - International Trade …

    https://www.trade.gov/market-intelligence/thailand-medical-device
    In February 2021, Thailand’s Food and Drug Administration issued new medical device regulations in compliance with the ASEAN Medical Device Directive …

A study of medical device regulation management model …

    https://pubmed.ncbi.nlm.nih.gov/27136699/
    In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. Areas covered: The study is a summary of the …



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