2014 ASEAN Agreement on Medical Device Directive

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Full Title	2014 ASEAN Agreement on Medical Device Directive
Short Title / Abbreviations	AMDD Agreement
CIL Subject Classification	ASEAN Documents ASEAN Economic Community ASEAN Economic Ministers ASEAN Socio-Cultural Community Health
Date of Adoption	21/11/2014
Place of Adoption	Bangkok, Thailand
Issued/Adopted by	Signed by Economic Ministers of ASEAN
Dispute settlement provisions	“ARTICLE 20: DISPUTE SETTLEMENT The ASEAN Protocol on Enhanced Dispute Settlement Mechanism signed on 29 November 2004 in Vientiane, Lao PDR and amendments thereto, shall apply to the settlement of disputes concerning the interpretation or implementation of this Agreement.”
Depository	Secretary-General of ASEAN
Annexes	Annex 1 – Essential Principles of Safety and Performance of Medical Devices Annex 2 – Risk Classification Rules for Medical Devices other than IVD Medical Devices Annex 3 – Risk Classification Rules for IVD Medical Devices Annex 4 – ASEAN Common Submission Dossier Template Annex 5 – Post Marketing Alert System (PMAS) Requirements Annex 6 – Components Elements of a Product Owner’s or Physical Manufacturer’s Declaration of Conformity (DOC) Annex 7 – Labelling Requirements Annex 8 – Clinical Investigation
Entry Into Force Status	In Force
Source	ASEAN Secretariat
Date of Entry into Force	01/01/2015
Entry into Force / Termination Provisions	“ARTICLE 22 ENTRY INTO FORCE (1) This Agreement shall be subject to ratification and/or acceptance by Member States in accordance with their internal domestic requirements. (2) This Agreement shall enter into force on 1 January 2015 and shall be in force only among the Member States that have ratified and/or accepted it. (3) The Secretary-General of ASEAN shall promptly notify all Member States of the notifications or deposit of each instrument of ratification and/or acceptance referred to in paragraph 1 of this Article.”
Status
ASEAN States	(Source: ASEAN Legal Instruments as of 05/01/2024)
Brunei Darussalam	Signature 21/11/2014
Cambodia	Signature 21/11/2014 Acceptance 27/03/2019
Indonesia	Signature 21/11/2014 Ratification 26/12/2018
Lao PDR	Signature 21/11/2014 Acceptance 04/12/2015
Malaysia	Signature 21/11/2014 Ratification 04/03/2020
Myanmar	Signature 21/11/2014 Ratification 06/09/2018
Philippines	Signature 21/11/2014 Ratification 04/03/2021
Singapore	Signature 21/11/2014 Ratification 02/11/2015
Thailand	Signature 21/11/2014 Ratification
Vietnam	Signature 21/11/2014 Acceptance 23/03/2016
Related Instruments
Related Instruments	1998 ASEAN Framework Agreement on Mutual Recognition Arrangements 2004 ASEAN Framework Agreement for the Integration of Priority Sectors 2004 ASEAN Sectoral Integration Protocol for Healthcare 2006 Mutual Recognition Arrangement on Nursing Services 2009 ASEAN Trade in Goods Agreement 2009 Mutual Recognition Arrangement for Medical Practitioners 2009 Mutual Recognition Arrangement on Dental Practitioners 2016-2025 ASEAN Standards and Conformance Strategic Plan “Forging Ahead Together: Ensuring Quality and Building Confidence”
External Links	ASEAN Legal Instruments accessed on 05/01/2024 ASEAN Secretariat accessed on 05/01/2024