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The Association of Southeast Asian Nations (ASEAN), a regional economic organization consisting of Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam is developing a combined regulatory system for medical devices to cover all member countries.

The ASEAN Medical Devices Directive (AMDD) uses elements from the European Medical Devices Directive, European guidelines (MEDDEVs), and Global Harmonization Task Force (GHTF) guidelines. Medical devices, active implantable medical devices, and in vitro diagnostic devices would all fall under AMDD jurisdiction.

Devices Directive, European guidelines (MEDDEVs), and Global Harmonization Task Force (GHTF) guidelines. Medical devices, active implantable medical devices, and in vitro diagnostic devices would all fall under AMDD jurisdiction.

There will be a four-tier device classification system based on risk using criteria established by the GHTF. Manufacturers are required to have an authorized representative and registration in each member state to manage registration efforts in each ASEAN country.

ASEAN directors have targeted an implementation deadline of December 2014 for the AMDD. Comments on the proposed Directive will be accepted until August 31, 2012.

Comments on the proposed Directive will be accepted until August 31, 2012.

Source: http://www.emergogroup.com/blog