Vietnam Decree 37/2026 Labelling: 0.9 mm Type and Transition

This is a living page: detailed labelling rules and transitional arrangements follow current MOH/IMDA practice.

Q: Which decree now governs labelling in Vietnam?

A: Decree 37/2026/NĐ-CP, issued and in force on 23 January 2026, replacing Decree 43/2017/NĐ-CP and its amending decree Decree 111/2021/NĐ-CP. Any Vietnamese label designed under 43/2017 must be re-checked against the new rules.

Q: What are the hard requirements of the new rules?

A: The core changes sit in five places:

1. Vietnamese mandatory — labels must be in Vietnamese (other languages may be added, but Vietnamese is required);
2. Minimum type size ≥ 0.9 mm — the new rules set a quantitative floor; the earlier “clearly legible” wording no longer applies;
3. Date format — the manufacturing date (NSX) and expiry date (HSD) must be shown in day-month-year format;
4. Supplementary label — imported devices may carry an additional Vietnamese supplementary label, provided its content and form comply;
5. Device-specific items (Appendix I, item 13) — the label must show the circulation registration number or import licence number, the batch or serial number, manufacturing and expiry dates, and device-specific content such as warnings, instructions for use, storage conditions and warranty information.

Q: What about old stock and labels already printed?

A: The new rules include transitional arrangements:

• Stock placed on the market before 23 January 2026 may continue to be sold through;
• Labels already printed may continue to be used for up to two years from entry into force, that is until 22 January 2028.

Both are pure time windows that end when they end, and they follow current MOH practice.

Q: What does a 0.9 mm minimum type size mean in practice?

A: It means the current layout of many small-format packs (small reagent vials, single-unit packs of small consumables) cannot accommodate the required information. Such products must either be redesigned with larger packaging or use a supplementary label or electronic information, where the new rules allow an alternative. This is the provision in Decree 37/2026 with the most direct effect on IVDs and small consumables.

Q: What happens if labelling and the filing do not match?

A: The device is not eligible for circulation (point b of Article 22 of Decree 98 requires the label to carry all the information required by law). Consequences include an order to correct, suspension of circulation of the batch, and in serious cases a recall.

Practical note: run a full-SKU label health check against three dimensions: whether the type size reaches 0.9 mm, whether dates use the day-month-year format, and whether every device-specific item in Appendix I, item 13 is present. Handle small packs first: they are the most likely to need redesign, and redesign involves packaging tooling and print cycles, so the earlier it starts the lower the cost.

Verification checklist (26 October 2026): (1) Decree No. 37/2026/NĐ-CP (issued and in force 23 January 2026, replacing Decree 43/2017 and Decree 111/2021), its main text and Appendix I, item 13; (2) the provisions on mandatory Vietnamese and a minimum type size of ≥ 0.9 mm; (3) the provision on date format (day-month-year); (4) the provision on supplementary labels; (5) the transitional provisions (sell-through of existing stock; printed labels for up to two years, until 22 January 2028); (6) Article 22 of Decree 98/2021/NĐ-CP (conditions for circulation).