网页ARTICLE 1 GENERAL PROVISIONS. (1) Each Member State shall undertake all necessary measures to ensure that only medical devices which conform to the provisions of this ASEAN Agreement on Medical Device Directive (hereinafter referred to as “Agreement”) and its Annexes may be placed on the markets of that Member State.
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ASEAN Medical Device Directive - ASEAN Main Portal
网页The objective of this agreement is to harmonised medical device regulations, common documents and the progress made in implementation.
ASEAN Medical Device Directive Implementation Updates
网页2019年9月6日 · While local laws of Singapore, Malaysia and Indonesia have fully complied with the ASEAN Medical Device Directive (AMDD), it is encouraging to see more developments of various Member States in ASEAN this year.
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网页The ASEAN Medical Device Directive (AMDD) is a harmonized medical device regulation applicable across the ASEAN countries. The Association of Southeast Asian Nations (ASEAN) has signed the ASEAN agreement on medical device …
ASEAN MEDICAL DEVICE DIRECTIVE – Where is it now?
网页2018年6月19日 · In 2015, the ASEAN Medical Device Directive (AMDD) agreement was signed in by all the 10 ASEAN countries – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. The agreement is to be fully implemented by 2020.
ASEAN Medical Device Directive Implementation: Current Progress …
网页2018年5月11日 · The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical device regulations and common technical documents which may help medical manufacturers easily penetrate the ASEAN Medical Device Market.
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