Consultation on AMDD

“From the Singapore Health Sciences Authority – Updated 2 August 2012 – As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) 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.

We would like to invite you to provide your feedback on AMDD using this form and send it to  by 31 August 2012. We regret to inform you that we are unable to include any comments received after the deadline for consideration due to time constraints.”

Template for Comments to AMDD due 31 Aug 2012

AMDD – Draft for consultation – 02 Aug 2012

Draft ASEAN Medical Devices Directive (AMDD)