ASEAN AMDD Harmonisation and Common Submission Dossier Template (CSDT)
Thailand participates in the ASEAN Medical Device Directive (AMDD) harmonisation programme, coordinated through the ASEAN Medical Device Product Working Group (MDPWG). The harmonised framework aligns classification rules, essential safety and performance principles, conformity assessment requirements, and the Common Submission Dossier Template (CSDT) across ASEAN member states.
For manufacturers exporting to multiple ASEAN markets, the CSDT provides a standardised technical documentation structure accepted by Thai FDA, Philippine FDA (CDRRHR), BPOM (Indonesia), HSA (Singapore), MDA (Malaysia), and DAV (Vietnam) — reducing duplication of effort across regional submissions.
🔖 Status: in-force
When preparing Thai FDA submissions, structure your technical documentation using the CSDT format and map your safety and performance data against the AMDD Essential Principles. Country-specific adaptations — Thai-language labelling, local distributor information, and Thai FDA cover forms — are still required.
View official source (Thai FDA) ↗