Technical Documents for AMDD Registration The ASEAN directive includes requirements for common tech

Technical Documents for AMDD Registration
The ASEAN directive includes requirements for common technical documentation that device manufacturers and sponsors would have to submit as part of the registration process.

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. Note that ASEAN CSDT guidance has existed since 2010.²

Typical components of a CSDT would include the following:

• Executive summary;
• Relevant essential principles and method used to demonstrate conformity;
• Device description;
• Summary of design verification and validation documents;
• Device labeling information; and
• Manufacturer information.