Vietnam Device Inspections: Unlicensed Sale and Overpricing Fines

Q: What do Vietnamese inspections focus on?

A: Inspections usually run along four lines:

1. Product access — whether there is a circulation number, a Declaration of Applicable Standards or an import licence (Article 22(a) of Decree 98);
2. Labelling and instructions — whether labels meet Decree 37/2026 (including a font size of at least 0.9 mm, the date format and device-specific items), and whether Vietnamese instructions for use and warranty information are present (Article 22(b), (c) and (d));
3. Company qualifications — whether Class B/C/D traders have completed the Trading Eligibility Declaration and whether staff and warehousing continue to meet Article 40;
4. Price and advertising — whether price declaration is complete, whether sales exceed the published price, and whether advertising is published on the portal and consistent with the declaration (Article 62).

Q: What happens to unlicensed circulation?

A: It is a serious violation of the circulation conditions. Article 22 makes holding a circulation number or an import licence the first condition of circulation, so without one there is no lawful basis to circulate. Consequences include an order to stop circulation, batch suspension, recall and administrative action. From 1 July 2025, the transitional arrangement allowing import and sale on a classification document has ended, and such conduct no longer has any policy cushion.

Q: What happens with sales above the published price?

A: Decree 98 expressly prohibits “trading devices without a declared price” and “trading at prices above those published on the MOH website“. This is a quantifiable and verifiable violation: comparing the portal price with the transaction records establishes it, the evidential burden is low, and it is therefore high-risk in inspections.

Q: What are the penalties for advertising violations?

A: Article 54 of Decree 38/2021/NĐ-CP (on administrative penalties in cultural and advertising activities, as amended) sets the penalties for device advertising violations. Read with Article 62, the most common problems are advertising content inconsistent with the declared scope (claiming undeclared indications or effects) and publishing without prior publication on the portal.

Q: Who carries out inspections?

A: At product level, the MOH/IMDA and the provincial Departments of Health divide the work: post-licensing inspection, batch suspension and recall for Class C/D are handled by IMDA, while Class A/B declarations and trading eligibility are received and supervised by the provincial Department of Health. Decree 04/2025 also confirms that the MOH may inspect and revoke an import licence in the event of a violation.

Practical note: run an annual compliance health check against the four lines, keeping a dated self-assessment record for each. The point is not “is there a violation” but “can compliance be evidenced“: portal publication screenshots, the Trading Eligibility Declaration publication, price declaration receipts, advertising publication receipts and adverse event records. In an inspection, being able to produce evidence and being in fact compliant are two different things.

Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 22 (the four circulation conditions); (2) Decree No. 98/2021/NĐ-CP, Article 62 (advertising) and Article 75.3; (3) Decree No. 38/2021/NĐ-CP (29 March 2021), Article 54; (4) Decree No. 37/2026/NĐ-CP (23 January 2026, labelling); (5) Decree No. 04/2025/NĐ-CP (MOH inspection and revocation of import licences); (6) Decree 98/2021/NĐ-CP price provisions.