ASEAN Common Submission Dossier Template (CSDT)
The ASEAN Common Submission Dossier Template (CSDT) is a standardised framework for organising the technical and administrative information required to support a medical device registration application across ASEAN member states, including Vietnam.
What is the CSDT?
The CSDT provides a common structure — a set of modules — that each ASEAN regulatory authority accepts as the basis for a Type C/D registration dossier. The goal is to allow manufacturers to prepare one core dossier that can be submitted (with country-specific adaptations) across multiple ASEAN markets.
Vietnam's Decree 98/2021 and DAV's guidance explicitly reference the CSDT as the accepted dossier format for Type C/D marketing authorisation applications.
CSDT modules for Vietnam
| Module | Content |
|---|---|
| Module 1 — Administrative Information | Cover letter, applicant details, device identification, classification justification, Certificate of Free Sale (CFS), Letter of Authorisation, list of countries where device is marketed |
| Module 2 — Device Description | Device name and models, intended purpose, principles of operation, technical specifications, components, accessories |
| Module 3 — Essential Principles Checklist | Completed checklist mapping each essential principle to the standards/tests used to demonstrate compliance |
| Module 4 — Design Verification & Validation | Test reports for bench testing, performance testing, software testing, usability, shelf life |
| Module 5 — Manufacturing Information | Manufacturing site details, process flow, QMS certificate (ISO 13485 / MDSAP) |
| Module 6 — Sterilisation | Sterilisation validation data (for sterile devices only) |
| Module 7 — Biocompatibility | ISO 10993 biological evaluation (for devices with body contact) |
| Module 8 — Clinical Evaluation | Clinical evidence summary — see Clinical Evidence |
| Module 9 — Risk Management | ISO 14971 risk management summary |
| Module 10 — Labelling | Vietnamese-language labels and IFU |
| Module 11 — Post-Market Surveillance Plan | Summary of planned PMS activities |
Country-specific adaptations for Vietnam
When adapting a CSDT prepared for another ASEAN country (e.g. Singapore HSA) for Vietnam:
- Module 1: Update CFS, LoA to reference the Vietnamese Authorised Representative; ensure CFS is legalised per Vietnamese requirements
- Module 3: Verify TCVN (Vietnamese national standards) in addition to ISO/IEC
- Module 10: Replace with Vietnamese-language labels and IFU
- Fees and submission: Vietnam uses the DMEC portal; submission format follows DMEC requirements
Leveraging existing submissions
If your device is already registered with HSA (Singapore), BPOM/Kemenkes (Indonesia), or another ASEAN authority, you can leverage much of the existing CSDT for a Vietnam submission:
Directly reusable modules: Modules 4 (Design Verification & Validation), 5 (Manufacturing Information), 6 (Sterilisation), 7 (Biocompatibility), 8 (Clinical Evaluation), and 9 (Risk Management) require minimal or no changes — the technical and safety data are consistent across ASEAN markets.
Adaptation required: Modules 1 (Administrative Information) and 10 (Labelling) require significant localisation — appointment of Vietnamese Authorised Representative, Vietnamese-language labels and IFU, updated legal declarations, and Vietnamese CFS.
Module 3 cross-check: Review the Essential Principles Checklist to ensure Vietnamese references (TCVN standards, DAV-specific requirements) are added alongside existing ISO/IEC citations.
Request the current CSDT template version from your Authorised Representative to ensure you are using the version accepted by DAV.
The CSDT is periodically updated by the ASEAN MDPWG. Confirm with your Authorised Representative that you are using the version currently accepted by DAV.
Submission Timelines & Review Process
Expected review period: 30 days for Type C; 45 days for Type D. Resubmission timelines for deficiency letters are typically 30 days from the notification date. Check the DMEC portal for current processing times and any backlog notices.
DAV Circular 17/2023/TT-BYT (30 September 2023) provides the current CSDT submission requirements for Type C/D applications. Confirm the accepted version with your Authorised Representative before submitting.