Vietnam Trading Eligibility Declaration: Procedure and 3-Day Updates
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How is a Trading Eligibility Declaration filed?
A: Article 41(2) of Decree 98/2021 sets out a two-step procedure:
- Step 1 (submission): before trading in medical devices begins, submit the declaration dossier to the provincial Department of Health where the trading premises are located, with evidence of the fee paid under Ministry of Finance rules;
- Step 2 (publication): once the Department of Health receives a complete dossier, it publishes the information and the dossier on the medical device management portal.
Note that there is no “approval” step: the procedure is essentially “submit and publish”. This does not mean the threshold is low. The substantive conditions in Article 40 are mandatory, and a declaration filed without meeting them is a false declaration.
Q: What goes into the dossier?
A: One set:
- The Trading Eligibility Declaration document (per the MOH template);
- A personnel declaration form (listing staff and evidence of their professional qualifications);
- Documents evidencing warehousing and transport conditions (self-certified and sealed by the declaring entity);
- Where applicable, documents on warehousing, import and export, and the inventory tracking system for narcotic substances and precursors.
Q: What is the fee?
A: Under the procedure list in Decision 2495/QĐ-BYT (4 August 2025) and the fee schedule in MOH Notice 645/TB-HTTB (2 July 2025), the fee for a Class B/C/D Trading Eligibility Declaration is:
- 1 July 2025 to 31 December 2026: VND 1,500,000;
- from 1 January 2027: VND 3,000,000.
(The standard rates derive from Circular 59/2023/TT-BTC; the reduced-period rates derive from Circular 64/2025/TT-BTC, issued on 30 June 2025 and valid from 1 July 2025 to 31 December 2026.)
Q: When must the declaration be submitted?
A: Before trading begins. A declaration cannot be added after Class B/C/D device trading has already started. This is often overlooked in practice, especially where a company wants to “run a few orders to test the water”; that amounts to trading without meeting the conditions.
Q: How strict is the 3-working-day update duty?
A: Article 41(2) requires that, where the declared information changes in the course of trading, the entity notify in writing with supporting documents and update the published dossier on the portal within 3 working days of the change. This is a quantified deadline, far stricter than vague wording such as “update in a timely manner”. It covers staff changes, a change of warehouse address and adjustments to transport arrangements.
Practical note: write the “3 working days” into the partner’s service agreement and assign a named person to portal updates. Build a change trigger list (replacement of technical staff, warehouse move, change of carrier, adjustment of business scope) so that the three-day clock starts the moment a trigger occurs. Such duties look minor, yet they are the easiest violations to prove in an inspection, because portal records are time-stamped and cannot be recreated afterwards.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 41(1) (dossier content) and Article 41(2) (two-step procedure and 3-working-day update); (2) Decree No. 98/2021/NĐ-CP, Article 40 (substantive conditions); (3) Decision No. 2495/QĐ-BYT (4 August 2025), procedure list and fees; (4) Circular No. 59/2023/TT-BTC (standard rates); (5) Circular No. 64/2025/TT-BTC (30 June 2025, 50% reduction); (6) MOH Notice No. 645/TB-HTTB (2 July 2025).
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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