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Vietnam Medical Device Advertising Requirements
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
Advertising requirements only apply to products marketed Directly to Consumers (DTC) and need to be submitted once the product’s license has been approved.
Please click here for an example of an Advertisement Certificate of Medtronic available publicly.
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Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Vietnamese market. Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in Vietnam.
Vietnam Regulatory Support
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