US: +1 512 898-9222
SG: +65 3138-4148
VietNam Independent License Holding
Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Vietnam to submit registration applications and act as Authorized Representative (AR). It is possible to use an Independent License Holder as the AR. The Vietnam AR will be responsible for post market vigilance reporting, the proactive traceability of devices on the market, and retention of device history documents. Since the AR does not need to be part of the importing process, manufacturers are able to import products with foreign labels and have local distributors apply the appropriate labeling.
AR responsibilities are non-transferable and products registered under the new rules will be able to be imported by multiple distributors by using the license holders MA licenses and an authorization letter from the license holder.
Appointing a trustworthy Authorized Representative is the foundation of a successful business strategy in Vietnam especially given most manufacturers will want to partner with different distributors in the north (Hanoi) and the south (Ho Chi Minh).
Asia Actual is a full-service provider of independent license holding services in Vietnam. Contracting with us as your Vietnam Authorized Representative allows you to:
- Sell directly to multiple regional distributors (avoiding mark-up by a national importer)
- Increase transfer pricing (as distributors are not investing in registration costs)
- Improve leverage in distributor negotiations/responses
- Secure intellectual property from local commercial agents
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual today if you have questions about license holding or labeling in the Vietnamese markets.
Vietnam Regulatory Support
US: +1 512 898-9222
- Vietnam’s MOH Holds Conference on Price DeclarationApril 11, 2022 - 1:13 pm
- Vietnam Requires Resubmission of Many Medical Device Registration ApplicationsJanuary 10, 2022 - 11:00 am
- Vietnam Releases New Medical Device RegulationsNovember 16, 2021 - 10:33 am
- VietNam Expedites Registration of COVID-19 Related Medical DevicesOctober 4, 2021 - 10:01 am
- VietNam’s MOH to Require CSDT Documentation for Class B, C, and D DevicesMay 24, 2021 - 6:53 pm