Vietnam Risk Analysis: C/D Risk Report and Standards List

Q: Does Vietnamese registration review the risk management file?

A: Class C/D requires a risk analysis report, which is one component of the dossier (alongside the classification conclusion, technical description, Vietnamese IFU, label drafts, product list, performance test reports, biocompatibility data and clinical evidence).

Q: How should the risk analysis be prepared to avoid rejection?

A: Three common rejection points map to three requirements:

1. A generic template is not enough — analyse each hazard specific to this product (energy hazards, biological hazards, environmental hazards, use error, software failure and similar);
2. Close the loop — identify the risk → evaluate the risk → apply control measures → verify the effectiveness of the controls → evaluate overall acceptability; none of the five steps can be missing;
3. Tie it to evidence — every control measure claimed in the analysis must be traceable to a test report, an IFU warning or a label warning.

Q: How should the list of applicable standards be written?

A: List each standard number + year of edition + specific clause, and cross-refer to the page in the evidence file. Do not write general statements such as “complies with the IEC 60601 series” — a frequent cause of deficiency requests. Areas that typically need coverage: electrical safety (IEC 60601 series), electromagnetic compatibility, biocompatibility (ISO 10993 series), sterilisation (ISO 11135/11137 and similar), software (IEC 62304, where applicable), usability (IEC 62366, where applicable) and risk management (ISO 14971).

Q: What is required of test reports?

A: They must be traceable to a specific standard number and edition, issued by a qualified laboratory, and within validity. Vietnam’s criteria for accepting test reports (whether foreign laboratory reports are accepted, whether local testing is required) follow current MOH rules — do not apply Indonesia’s local testing list to Vietnam; the two countries’ mandatory local testing requirements differ.

Q: How does the technical summary relate to the CSDT?

A: Since 1 January 2024, Class C/D dossiers must use the CSDT format. The technical summary is one of the core parts of the CSDT structure and must be completed against the template headings rather than attached as a separate document. The earlier transitional option of substituting “technical summary + Vietnamese IFU + label” has ended.

Practical note: turn the risk analysis into a traceability matrix: one row per hazard, with severity and probability, control measures, the page of the verifying evidence and the residual risk evaluation. The matrix can be reused directly in Vietnamese review, in CE/FDA reviews and in later change assessments, which makes it the technical document with the best return on effort.

Verification checklist (26 October 2026): (1) the Class C/D dossier requirements in Decree 98/2021/NĐ-CP (the risk analysis report is mandatory); (2) the CSDT template (mandatory for Class C/D from 1 January 2024); (3) the ISO 14971 risk management standard; (4) the list of applicable standards (IEC 60601, ISO 10993, ISO 11135/11137, IEC 62304, IEC 62366 and others, depending on the product); (5) Article 147.19 of Decree 96/2023/NĐ-CP (certificate of clinical test results, 1 January 2026).