Vietnam CSDT Dossier: Filing Requirements for Class C and D Devices
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What is the CSDT?
A: The CSDT (Common Submission Dossier Template) is the harmonised application dossier format under the ASEAN Medical Device Directive (AMDD). Under the transitional arrangements in Decree 98, Vietnam has required Class C and Class D applications to use the CSDT since 1 January 2024.
Previously, for files submitted before 31 December 2022, three items were allowed in its place: a technical summary, instructions for use for the Vietnamese market, and labelling. That transitional arrangement has ended.
Q: What does the CSDT contain?
A: Following the ASEAN template structure, it is built on three core blocks, administrative information, device description and evidence of conformity. It covers product and manufacturer information, the basis for classification, the list of applicable standards, design and manufacturing information, performance and safety evidence (test reports, biocompatibility, sterilisation, electrical safety and software), risk analysis, clinical evidence, labelling and instructions for use, and quality system evidence.
Q: What are the five most common filing errors?
A:
- Model or specification mismatch with the LoA: the product list in the CSDT must correspond item by item to the scope authorised in the LoA;
- The applicable standards list says “see the country-of-origin report” without naming the specific standard numbers and versions, which draws a request for further information;
- The risk analysis is a generic template, with no analysis of the specific hazards of this device;
- The clinical evidence lacks a chain: only the conclusion is submitted, without the protocol, the report and the ethics or approval documents;
- Vietnamese materials are missing: labelling and instructions for use must exist in Vietnamese, and machine translations are not accepted in review.
Q: Can existing CE or FDA material be moved straight into the CSDT?
A: The content can be reused, but the format must be restructured. The CSDT is not a way of packaging up the technical documentation; it is a fixed set of items to be answered one by one. The common mistake is to attach an entire CE technical file without answering the CSDT items individually, which is treated as a failure to submit on the template.
Practical note: treat the CSDT as an answer sheet rather than a filing cabinet. Every item needs a clear answer and a page reference to the supporting evidence, and items that do not apply should state “N/A” with the reason rather than being left blank. This habit can bring deficiency rounds down from two or three to one or fewer.
Verification checklist (26 October 2026): (1) Article 76 of Decree 98/2021/NĐ-CP, transitional provision, CSDT mandatory from 1 January 2024; (2) the relevant amendments in Decree 07/2023/NĐ-CP; (3) the ASEAN CSDT template structure; (4) Article 147.19 of Decree 96/2023/NĐ-CP (clinical investigation completion certificate, in force 1 January 2026); (5) Decree 37/2026/NĐ-CP (labelling requirements).
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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