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ASEAN Medical Device Directive

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

    ASEAN Medical Device Committee (AMDC) - HSA

      https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/amdc
      Find out about the collaborations under the ASEAN Medical Device Committee (AMDC). About the AMDC The ASEAN Medical Device Committee (AMDC) …

    ASEAN MEDICAL DEVICE DIRECTIVE - Asia Actual

      https://asiaactual.com/wp-content/uploads/2020/11/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
      Medical Device Directive 2015 3 (3) Subject to the provisions of this Agreement, each Member State shall require that the person responsible for placing the …

    MEDICAL DEVICE GUIDANCE - Home - ASEAN …

      https://www.asean.org/wp-content/uploads/images/archive/SnC/Guidance%20to%20ASEAN%20CSDT_Final_21%20Oct%202010.pdf
      Definitions that do not indicate they are set out in the ASEAN Medical Device Directive (AMDD) or the legislation of AMS are intended as guidance in this document. These …

    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
      1. Medical Devices (Establishment Duties and Obligations) Regulations 2019. Starting from July 1, 2022, MDA will effectively enforce the Medical Devices …

    ASEAN AGREEMENT ON MEDICAL DEVICE …

      https://www.hsa.gov.sg/docs/default-source/hprg/regulatory-updates/amdd---draft-for-consultation---02-aug-2012.pdf
      ASEAN Medical Device Directive Version 11, Draft for National Consultation Dated 08 May 2012 Page 7 of 124 (b) permanent or temporary changes to the labelling or instructions …

    Comparing Attributes of the ASEAN Medical Device …

      https://meridian.allenpress.com/bit/article/53/3/208/427881/Comparing-Attributes-of-the-ASEAN-Medical-Device
      European Union (EU) and Association of Southeast Asian Nations (ASEAN) medical device directives and regulations: timeline of key milestones. Abbreviations …

    ANNEX A ANNEX 5 of the ASEAN Medical Device …

      https://members.wto.org/crnattachments/2022/TBT/PHL/22_1545_01_e.pdf
      ANNEX 5 of the ASEAN Medical Device Directive (AMDD) Post Marketing Alert System (PMAS) Requirements 1. INTRODUCTION 1.1. Purpose This document aims to provide …

    ASEAN MEDICAL DEVICE DIRECTIVE

      https://www.access2hc.com/asean-medical-device-directive-where-is-it-now/
      In 2015, the ASEAN Medical Device Directive (AMDD) agreement was signed in by all the 10 ASEAN countries – Brunei, Cambodia, Indonesia, Laos, …

    Draft for Comments of List of Class A Medical Devices

      https://www.fda.gov.ph/draft-for-comments-of-list-of-class-a-medical-devices/
      On 26 January 2018, DOH Administrative Order (AO) No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN …



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