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October 16, 2025
Approximately 5 minutes
Medical Device Advertising: Mandatory Public Portal Submission
Vietnam Medical Device Advertising: Mandatory Public Portal Submission and Content Requirements
Medical device advertising in Vietnam is strictly regulated by the Ministry of Health (MoH) under the provisions of Decree 98/2021/ND-CP, with requirements implemented since July 2022. The key regulatory mechanism is the mandatory submission of all promotional materials to a public portal.
Mandatory Public Portal Submission
Per Article 62 of Decree 98/2021, a broad range of promotional content must be uploaded to the MoH public portal before the advertisement is placed on the market.
- Scope: This requirement applies to ALL advertising material, regardless of the medium (print, internet, video, etc.) and regardless of the target audience (Direct-to-Consumer (DTC) or healthcare professionals).
- Compliance Process: Once the material is successfully uploaded to the public portal (a process for which there is currently no fee), a unique circulation number is provided. This number must then be prominently included in the advertising material.
- Enforcement: Advertisements that fail to meet the MoH's requirements or do not display the circulation number may be removed from the market.
Mandatory Advertising Content
All approved advertising materials must contain specific, verified information to ensure transparency and accountability. This includes:
- Product Identification: Name of medical equipment, type, product code, manufacturer, and manufacturing country.
- Circulation Number: The unique number provided by the MoH public portal upon submission.
- Features and Effects: Clear statement of the device's features and effects (therapeutic claims).
- License Holder Information: Name and address of the License Holder (of the free-sale registration number) or the organization authorized by the License Holder.
- Warnings: Warnings related to the user's health and storage conditions (if any).
Exemptions from Public Portal Submission
Certain types of materials are exempt from the mandatory upload requirement, as they are not considered direct advertisements or are intended purely for technical or internal use:
- Materials that do not refer to the medical device name.
- Materials that only list names and technical specifications of medical equipment but contain no information on features and effects.
- Scientific research papers and clinical documentation.
- Training materials supporting product manuals (Instructions for Use).
Compliance with these submission and content requirements is essential for ensuring the legality of any promotional activities in the Vietnamese medical device market.
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