Medical device advertising requirements in Vietnam are addressed by the Government of Vietnam (GVN) Circular 09/2015. At this time, all advertising material (e.g., print, internet, or video) marketed Direct-to-Consumer (DTC) must be reviewed and licensed by the MOH prior to being utilized. The review usually takes about 30 days and about US $5 per application. Once approved, advertising licenses remain valid to the expiry date of the product’s Import License or MA License.
Under Circular 09/2015/TT-BYT, article 13, the following documentation will need to be submitted for review:
- Application form in Appendix 01 issued with Circular 09/2015/TT-BYT
- Certificate of business registration (Import license holder or company that have LOA from license holder)
- License to import medical equipment (Import License) or certificate of registration of circulation of medical equipment (MA License)
- Content of request for endorsement of advertising on advertising media other than audio and video newspapers
Timeline: 2 weeks
Advertisements, including audio and video, for medical equipment must contain the following:
- name of the medical equipment, type, manufacturer, country of manufacture;
- circulation number;
- features and effects;
- and more.
Please click here for an example of an Advertisement Certificate of Medtronic available publicly.
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Using Asia Actual as your License Holder in Vietnam comes with the added benefit of expertly managed, efficient and transparent advertising approvals.
Contact Asia Actual for more information on our advertising approval assistance.
Vietnam’s MOH Holds Conference on Price DeclarationApril 11, 2022 - 1:13 pm
