The AMDD would give member states' regulatory agencies the authority to issue final classification rulings on devices in instances where disputes regarding proper classification arise.
Evaluating medical devices' compliance with the AMDD would be accomplished via conformity assessments, according to a draft of the directive.
It is important to distinguish between AMDD conformity assessments and those used in the European Union.
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.
Based on GHTF Summary Technical Documents as well as MEDDEV guidance from the European Union, documents necessary for AMDD registration include ASEAN Common Submission Dossier Templates (CSDT) aimed at harmonizing documentation format discrepancies among different ASEAN member states, eliminating the need to submit multiple dossiers in different formats but with similar or identical content to different Southeast Asian regulators.
AMDD compliance would also entail more robust post-marketing requirements for device manufacturers throughout all ASEAN member states.
In some cases, AMDD requirements are the same as GHTF requirements.
This makes it one of the most significant parts of the AMDD.
Besides the CSDT, the other major document the AMDD requires for medical device approval is the Declaration of Conformity.
The AMDD also contains guidelines for member governments' medical device review processes, otherwise known as conformity assessment.
As a rule, local clinical trials should not be required under the AMDD for Class I and II devices.
Besides registration, the other main component of the AMDD is the post-marketing alert system.