Vietnam Labelling Checks Under Decree 37/2026: Inspection Focus

This is a living page: inspection practice and transitional arrangements follow the MOH/IMDA position in force at the time.

Q: Do inspections cover device labelling?

A: Yes, and labelling is the most visible and easiest item to evidence on site. Article 22(b) of Decree 98 requires labels to carry all the information required by the goods labelling rules in force; Article 22(c) and (d) require Vietnamese instructions for use and warranty information. The labelling rules in force are Decree 37/2026/NĐ-CP (issued and in force on 23 January 2026, replacing Decree 43/2017 and 111/2021).

Q: Which items are checked?

A: Under the core requirements of Decree 37/2026, five points matter:

1. Vietnamese — labels must be in Vietnamese, with other languages permitted as additions but Vietnamese mandatory;
2. font size of at least 0.9 mm — the new rules set a quantitative minimum;
3. date format — production date (NSX) and expiry date (HSD) in day-month-year order;
4. supplementary labels — where a Vietnamese supplementary label is affixed to imported devices, its content and form must comply;
5. device-specific items (Appendix I, item 13) — circulation registration number or import licence number, batch or serial number, production and expiry dates, warnings, instructions for use, storage conditions and warranty information.

The fifth is the extra requirement for devices over ordinary goods, and it is the item that most often fails in inspection.

Q: What about small packages?

A: This is the most practical problem once Decree 37/2026 takes effect: small pack formats cannot fit all the mandatory information. There are two routes: (1) enlarge or redesign the packaging; (2) provide the information through the supplementary label or electronic information allowed by the new rules (Article 22(3) of Decree 98 allows instructions for use and warranty information in electronic form, provided the label clearly states how to access it).

Which route applies must be judged against the text of Decree 37/2026 and the current MOH position; do not assume.

Q: How should the transition period be used?

A: Decree 37/2026 provides transitional arrangements: stock already on the market before 23 January 2026 may be sold through, and labels already printed may continue to be used for up to 2 years from entry into force, that is until 22 January 2028. This is a pure time window that ends when it ends. Companies should schedule the redesign inside the window rather than waiting for the deadline.

Q: What happens if the label does not match the product?

A: It is a failure to meet the circulation conditions and can trigger corrective action, batch suspension of circulation and even recall (Articles 34 and 37). A label inconsistent with the application dossier will also be picked up in advertising compliance (Article 62 requires advertising to match the declaration) and in the price declaration step.

Practical note: run a full-SKU labelling health check and produce a table showing, for each SKU, the pack dimensions, the current font size, whether all mandatory items fit, whether redesign or a supplementary label is needed, and the redesign lead time and cost. That table is the basis both for negotiating with packaging suppliers and for requesting budget from management, and it is far more effective than a verbal explanation.

Verification checklist (26 October 2026): (1) Decree No. 37/2026/NĐ-CP (issued and in force on 23 January 2026), main text and Appendix I, item 13; (2) mandatory Vietnamese and a minimum font size of at least 0.9 mm; (3) the date format (day-month-year); (4) the supplementary labelling provisions; (5) the transitional provisions (existing stock sold through, printed labels for up to 2 years to 22 January 2028); (6) Decree No. 98/2021/NĐ-CP, Article 22 (the four circulation conditions and the electronic information alternative), and Articles 34 and 37 (handling).