Vietnam Device Advertising: Article 62 Content and Portal Filing
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Does medical device advertising require approval in Vietnam?
A: No prior approval, but publication on the portal is mandatory. Article 75.3 of Decree 98/2021 repealed the requirement in Articles 7 and 12.1 of Decree 181/2013/NĐ-CP that advertising content be confirmed by the competent authority. In its place: before advertising is published, the circulation number holder, or an organisation authorised by it in writing, must publish the content and form of the advertisement on the medical device management portal. The requirement took effect on 1 July 2022.
Q: What must the advertising content be consistent with?
A: Article 62 of Decree 98 requires device advertising content to conform to one of the following:
- the Declaration of Applicable Standards dossier for a Class A or Class B device; or
- the circulation registration dossier for a Class C or Class D device.
In other words, advertising may not go beyond what has been declared, and this is the core principle of Vietnamese advertising regulation.
Q: Which five items must an advertisement contain?
A: Article 62 requires device advertising to include:
- device name, type, product code, manufacturer and country of manufacture;
- the circulation number;
- characteristics and efficacy;
- the name and address of the circulation number holder, or of the organisation it has authorised;
- warnings relating to user health and storage conditions, where applicable.
Advertising in audio, video or print form must read out or clearly display the above information.
Q: Who is responsible for advertising content?
A: The circulation number holder, or an entity authorised by it in writing, bears legal responsibility for the consistency of the advertising content with the intended content published on the portal. When promoting in Vietnam, a manufacturer must therefore ensure that all advertising materials are confirmed by the MAH and published before release. Publishing without publication exposes the holder, but both parties carry the commercial consequences.
Q: What does not count as advertising?
A: Article 62 excludes: materials or articles that do not mention the device name; documents or items that list only the device name or technical parameters, without information on characteristics and efficacy; scientific research papers and clinical documents; and training materials supporting product manuals. These are not promotional materials.
Q: What are the penalties for breaches?
A: Article 54 of Decree 38/2021/NĐ-CP (29 March 2021, on administrative penalties in cultural and advertising activities, as amended) sets the penalties for device advertising violations.
Practical note: make publication of the advertising content on the portal a pre-release condition for marketing materials. The flow is: marketing prepares the material, the MAH reviews whether it stays within the declared scope, the MAH publishes it on the portal, the publication receipt is obtained, and the material is released. Miss any step and liability falls on the holder, and the manufacturer often learns only afterwards.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 62 (the five required advertising content items, the exclusions and the responsible party); (2) Decree 98/2021/NĐ-CP, Article 75.3 (repealing the prior confirmation requirement in Articles 7 and 12.1 of Decree 181/2013); (3) the advertising publication requirement in force from 1 July 2022; (4) Decree No. 38/2021/NĐ-CP (29 March 2021), Article 54 (penalties for advertising violations); (5) the advertising publication section of the MOH medical device management 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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