Vietnam LoA: Circular 44/2025 Template and Decree 98 Articles 25-27
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Is an LoA mandatory for registration in Vietnam?
A: Yes. An overseas manufacturer, as the product owner, must use a Letter of Authorization (LoA) to authorise a Vietnamese legal entity (the MAH) to file on its behalf and to hold the circulation number or the Declaration of Applicable Standards. The legal basis is Articles 25, 26 and 27 of Decree 98/2021/NĐ-CP (Article 26 covers Class A/B declarations, Article 27 covers Class C/D circulation registration).
Q: Does the LoA have a prescribed format?
A: Yes, and the template is mandatory. Circular 44/2025/TT-BYT sets the mandatory template for the LoA. This means that “drafting your own letter” or “reusing a letter from another country” is no longer accepted. This has been the most direct change to Vietnamese filing documentation since 2025, and one of the single largest causes of dossier rejection.
Q: What matters most inside an LoA?
A: Four design points:
- Scope of authorization — it must cover “filing + holding the registration + post-market obligations (vigilance, recall, changes)”. A letter that says only “apply for registration” will stall at a later stage;
- Product list — list every model, and match it exactly to the models in the CSDT, the labelling and the invoices;
- Term of authorization — it must cover the review cycle with margin. Deficiencies or refusals arising from the validity period of an LoA fall within the priority processing provisions of Decree 96/2023, but it is better to avoid them from the outset;
- Signature and authentication — the authentication chain applies (from 11 September 2026, judged under the Apostille rules; see part 24).
Q: Can one LoA cover several holders?
A: Vietnamese LoA practice differs from Indonesia’s strict “one brand, one holder” rule, but at product registration level the circulation number for a given product is normally tied to one holder. The more common and more robust arrangement is for the LoA to be granted to an independent MAH that holds the registration, which then issues import authorisations to several importers or distributors (Article 47.2 of Decree 98; see part 35). This allows multi-distributor coverage without touching the registration certificate.
Q: What happens when the LoA expires or the holder changes?
A: This is a change event. The priority processing provisions of Decree 96/2023 expressly list “change of registration holder or importer” as a ground for priority processing, which shows that a formal channel exists. In practice, difficulty depends on whether the outgoing holder cooperates in issuing release or transfer documents — which is exactly what should be thought through when choosing a holding model.
Practical note: treat the LoA as a document of commercial control, not merely filing material. If the scope is drawn narrowly, any later change of distributor, variation or recall will send you back to the manufacturer for supplementary documents. If the scope is drawn fully, the manufacturer’s control over the Vietnamese market is in fact stronger, because the initiative sits with the MAH, and the MAH is bound by the LoA. Have the manufacturer’s regulatory and legal teams finalise it jointly; do not leave drafting to an agent and sign whatever comes back.
Verification checklist (26 October 2026): (1) Articles 25, 26 and 27 of Decree 98/2021/NĐ-CP; (2) Circular No. 44/2025/TT-BYT (mandatory LoA template); (3) Article 147 of Decree 96/2023/NĐ-CP (priority processing for a change of holder; deficiencies or refusals caused by LoA validity); (4) Article 47.2 of Decree 98/2021/NĐ-CP (import authorisation issued by the holder); (5) the date the Apostille Convention took effect for Vietnam (11 September 2026).
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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