Consultation on AMDD

[Updated on 2 August 2012] As part of efforts to enhance economic integration among ASEAN member states, ASEAN has been working on developing a standardised framework for regulating medical devices that is targeted for implementation by December 2014. This draft set of broad principles is called the ASEAN Medical Devices Directive (AMDD), and it is now ready for industry consultation. This published AMDD is not the final version, and there may be changes depending on feedback received from you and other interested parties.

The consultation is now closed.

AMDD - Draft for consultation - 02 Aug 2012.pdf1169 KB

Template for Comments to AMDD40 KB

Published: 2 Aug 2012

Regulatory Updates