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Harmonization Efforts in Asia-Pacific - DIA Global Forum

    https://globalforum.diaglobal.org/issue/april-2021/aligning-combination-products-regulations-in-asia-pacific-a-distant-dream/
    n the current innovation era and in the wake of COVID-19, two topics of rising importance for enabling patient access to newer treatment modalities are regulatory harmonization and drug-device combination products. For patients and healthcare systems globally, there …

The ASEAN harmonization of technical standards …

    https://www.raps.org/news-and-articles/news-articles/2021/6/journey-of-the-asean-harmonization-of-technical-st
    The health supplements industry and ASEAN member state regulators should continue the culture of public-private partnership in fostering the success of the Agreement by realizing …

Guidelines published for transition in Philippines to ASEAN …

    https://www.emergobyul.com/news/guidelines-released-transition-philippines-asean-harmonized-requirements
    Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements. March 24, 2021. The Food and Drug Administration of the Philippines …

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 Harmonisation of Traditional Medicines and …

    https://www.hsa.gov.sg/international-collaboration/international-collaboration-complementary-health-products/asean
    ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Traditional Medicines and Health Supplements. …

Global Medical Device Regulations

    https://www.oliverhcp.com/news-and-resources/packtalk/global-medical-device-regulations-harmonization-efforts-of-sterile-medical-packaging-standards
    Despite all the needs, there remain several challenges to achieve the harmonization of medical device regulations: 1) Diversity in culture, language, politics, economy, race, religion; …

Medical Device Harmonization in …

    https://www.pacificbridgemedical.com/publication/medical-device-harmonization-in-southeast-asia/
    One of the biggest challenges to foreign medical device companies doing business in Southeast Asia has been the unpredictable regulatory environment for medical devices. …

ASEAN’s growing demand for medical …

    https://theaseanpost.com/article/aseans-growing-demand-medical-devices
    The medical device market within ASEAN is expected to be worth US$8.5 billion by 2020. This is representative of a compound annual growth rate (CAGR) of almost 10 percent. …

ASEAN’s harmonisation towards …

    https://theaseanpost.com/article/aseans-harmonisation-towards-healthcare
    In the context of harmonising standards and conformance in healthcare services, ASEAN has issued the ASEAN Medical Device Directive (AMDD) to support trade in the region by …

Whatever happened to the ASEAN medical device …

    https://trends.medicalexpo.com/project-412018.html
    ASEAN officials provided an update on AMDD implementation progress at a meeting of the 20th Asian Harmonization Working Party (AHWP) Annual Meeting in November 2015. There, ASEAN …



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