Vietnam IFU and Warranty: Decree 98 Article 22 Conditions
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What conditions must a device meet to be marketed in Vietnam?
A: Article 22 of Decree 98/2021/NĐ-CP (as amended by Decree 07/2023/NĐ-CP) sets four conditions for circulation, all of which must be met:
- a) a circulation number, circulation registration number, circulation registration certificate or import licence has been obtained (except in cases such as lawful liquidation, expiry of the product, failure to eliminate hazards, or the competent authority not permitting use);
- b) a label carrying all the information required by the goods labelling rules in force;
- c) instructions for use in Vietnamese;
- d) information on the warranty provider, warranty conditions and warranty period (except for single-use devices, or where the product owner specifies or documents that no warranty applies).
Q: Which Article 22 item is most often missed?
A: Item d, warranty information. Many imported devices have an IFU with no name and address for a Vietnamese warranty provider and no warranty period; in Vietnam this is a condition of circulation, not an option. There are two remedies: (1) add the Vietnamese warranty provider’s details to the IFU or label; (2) where no warranty applies, hold a statement or documentary evidence from the product owner.
Q: May the IFU be supplied outside the packaging?
A: Yes, but it must be in electronic form. Article 22.3 provides that where item c (IFU) and item d (warranty information) are not supplied with the device, they must be provided in electronic form, and the device label must clearly state how to access that information. In other words, “scan the code to read the IFU” is permitted, but the label must carry clear directions for finding it.
Q: Must labelling, IFU and registration information match?
A: They must. The product name, model, manufacturer and MAH details and the circulation number on the label must match the portal publication and the dossier. A mismatch means the device does not meet the conditions of circulation. This is also why Decree 37/2026 makes the circulation registration number or import licence number a mandatory label item: it allows regulators and end users to check.
Practical note: run a three-way check across label, IFU and portal publication, comparing item by item the product name, model, manufacturer name and address, MAH name and address, circulation number, batch and serial numbering rule, date format and warranty provider. This single table covers both Article 22 of Decree 98 and Appendix I, item 13 of Decree 37/2026, and is the last self-check before launch in Vietnam.
Verification checklist (26 October 2026): (1) Article 22 of Decree No. 98/2021/NĐ-CP (as amended by Article 1.2 of Decree 07/2023/NĐ-CP: the four conditions of circulation and the electronic alternative in paragraph 3); (2) Appendix I, item 13 of Decree 37/2026/NĐ-CP (device-specific label items); (3) Article 2.5 of Decree 98/2021/NĐ-CP (product owner); (4) the information fields published on the MOH portal.
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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