Vietnam Language Rules: Which Documents Must Be in Vietnamese
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Must all Vietnamese registration documents be translated into Vietnamese?
A: Not all, but some parts must be in Vietnamese. The rules are:
- Vietnamese required: the instructions for use (IFU), labelling, user-facing promotional material, and some information needed for portal publication;
- English may be retained (with key Vietnamese material): the body of the technical file (test reports, risk analysis, clinical data and similar) is in practice accepted in English, but a Vietnamese summary or a translation of key sections must be provided as the review requires;
- Notarised Vietnamese translation required: authenticated legal documents (LoA, CFS and similar).
The specific requirements follow current MOH requirements and the actual practice of the receiving authority.
Q: Why are machine translations rejected?
A: Because Vietnamese review assesses the technical accuracy and readability of Vietnamese material on substance. Machine-translated IFUs commonly contain terminology errors, ambiguous dosing or parameter statements, and weakened warnings — precisely the highest-risk parts of a device instruction leaflet. Once identified, retranslation is required and counts as a deficiency item (consuming one of the permitted deficiency responses; see part 16).
Q: How is translation quality controlled?
A: Three practical measures: (1) use Vietnamese translators with a medical background, not a general translation agency; (2) build a terminology list (product names, models, component names, warnings) and apply it across the whole dossier; (3) after translation, have it checked twice — by the manufacturer’s technical team and a Vietnamese pharmacist or engineer.
Q: What is required in the technical summary?
A: Class C/D is filed under the CSDT, and its technical description must be complete and verifiable, with cited test reports traceable to a specific standard number and edition. A common rejection wording is “complies with the IEC 60601 series” without naming the standard number and year of edition; the reviewer will request a deficiency response.
Q: Must label drafts be submitted as well?
A: Yes. The dossier must include label and packaging drafts for the Vietnamese market, and the drafts must comply with the labelling rules in force (Decree 37/2026/NĐ-CP, in force from 23 January 2026; see part 26). Drafts that differ from the label actually used on the market are an inconsistency that can be penalised at inspection.
Practical note: build the terminology list plus a bilingual alignment table as a project asset. Do it once for the first product (roughly 50 to 100 entries) and reuse it for every later model; translation quality and consistency improve markedly and review rounds fall. The marginal cost is very low and the reuse value very high.
Verification checklist (26 October 2026): (1) Article 22 of Decree 98/2021/NĐ-CP (as amended by 07/2023: Vietnamese instructions for use, warranty information); (2) the Class C/D dossier requirements in Decree 98/2021/NĐ-CP; (3) CSDT template requirements (mandatory for Class C/D from 1 January 2024); (4) Decree 37/2026/NĐ-CP (23 January 2026, labelling); (5) current MOH/IMDA guidance on Vietnamese-language material.
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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