ASEAN Common Submission Dossier Template (CSDT)
The ASEAN Common Submission Dossier Template provides a common structure for medical device registration dossiers in ASEAN markets. It reduces formatting differences but does not create a single ASEAN application or approval.
What is the ASEAN CSDT?
The ASEAN Common Submission Dossier Template is a standardized format for presenting medical device technical information to ASEAN regulatory authorities. It is included in the official ASEAN Medical Device Directive agreement.
The template aims to reduce the need to rearrange substantially similar evidence into a different format for every member state.
What information is included in a CSDT dossier?
A CSDT generally organizes information such as an executive summary, essential principles evidence, device description, design verification and validation, clinical evidence where applicable, labeling, risk analysis and manufacturer information.
The necessary depth depends on the device’s risk class and complexity. A dossier should explain why a section is not applicable rather than silently omitting expected information.
Which ASEAN markets use the CSDT?
CSDT-based documentation is relevant across ASEAN medical device markets, including Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines.
Implementation is national. Each authority may maintain its own portal, forms, local representative rules, fees, language requirements and administrative documents.
Is one CSDT accepted unchanged throughout ASEAN?
No. CSDT creates a common core, not a centralized filing. A manufacturer may reuse substantial technical content, but each submission must be checked against the current national rules.
Reference-market evidence, declarations, certificates, labeling and letters of authorization may also differ. Changes to a device or its evidence can require market-specific updates.
Does CSDT apply to IVDs?
The AMDD framework allows authorities to use CSDT for IVDs or prescribe another submission format. Authorities may publish separate guidance for general medical devices and IVDs.
For example, Singapore HSA maintains distinct current guidance for general medical devices and IVD dossiers on its official medical device guidance page. Manufacturers should use the latest guidance for the product type and route instead of assuming one template covers both.
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