Authorized Representation Mandatory Although the AMDD would create a single regulatory framework fo

Authorized Representation Mandatory
Although the AMDD would create a single regulatory framework for Southeast Asia, the directive at this point would not go so far as to create a single multi-national market for medical devices such as the European Union. Obtaining marketing authorization in one ASEAN member state does not grant all-in-one access to all member states, in other words. As such, manufacturers with no local presence in the ASEAN member state in which they seek to market their products must appoint in-country representatives to manage their registrations and interact with regulators on their behalf.