ASEAN MEDICAL DEVICE DIRECTIVES [ AMDD ] UPDATES
ASEAN MEDICAL DEVICE DIRECTIVES [ AMDD ] UPDATES
ASEAN MEDICAL DEVICE DIRECTIVES [ AMDD ] UPDATES
ASEAN MEDICAL DEVICE DIRECTIVES [ AMDD ] UPDATES
The ASEAN Medical Device Committee ( was formed in 2014 (earlier was ACCSQ MDPWG) to coordinate the implementation of the AMDD, an agreement between the 10 ASEAN members states to harmonise medical device regulatory framework The key objective is to facilitate trade and market access of medical devices in ASEAN by reducing technical barriers Establishing common understanding of AMDD through the development of an interpretive matrix Harmonising requirements for adverse events reporting through the implementation of guidelines on post market surveillance Aligning the risk classification of medical devices across ASEAN member states
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