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ASEAN Medical Device Directive

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

    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/
      While the International Council on Harmonization (ICH) has made great strides in the alignment of drug regulations over the past thirty years, and the International Medical …

    Guidelines published for transition in Philippines to ASEAN …

      https://www.emergobyul.com/news/guidelines-released-transition-philippines-asean-harmonized-requirements
      New circular establishes registration of previously exempt medical devices. This year, the FDA of the Philippines published Circular No. 2021-002, which provides …

    The ASEAN harmonization of technical standards on …

      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 the true benefits of …

    MEDICAL DEVICE GUIDANCE - Home - ASEAN …

      https://www.asean.org/wp-content/uploads/images/archive/SnC/Guidance%20to%20ASEAN%20CSDT_Final_21%20Oct%202010.pdf
      The ASEAN CSDT document contains elements of the GHTF guidance document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential …

    MEDICAL DEVICES PRODUCT STANDARDS …

      https://www.asean.org/wp-content/uploads/images/archive/SnC/medical_devices_standards_for_harmonisation_ao%2017%20june%202013.pdf
      MEDICAL DEVICES PRODUCT STANDARDS (HARMONISATION STATUS) MEDICAL DEVICES LEGEND REG Standards used in regulations GOV Standards used in …

    Home | GHWP

      http://www.ahwp.info/
      After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document ' Categorisation of Changes to a Registered …

    Medical Device Harmonization in Southeast Asia

      https://www.pacificbridgemedical.com/publication/medical-device-harmonization-in-southeast-asia/
      MEDICAL DEVICE CLASSIFICATION The AMDD sets up a risk-based classification system based on GHTF guidelines. According to the AMDD, medical devices — including in-vitro diagnostics (IVDs) — …

    HARMONIZATION OF STANDARDS IN ASEAN

      https://asean.org/harmonization-of-standards-in-asean/
      Basic Principles of Harmonisation. During this harmonisation exercise, the national standards bodies in ASEAN or similar bodies would need to adopt the …

    the asean picture of harmonized controls for medical devices

      https://vdocuments.net/the-asean-picture-of-harmonized-controls-for-medical-devices.html
      Harmonization of medical device regulation:- Reduce the time to market access & facilitate trade Reduce the cost to market Improve regulatory efficiency …



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