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 listed on the local labeling and is responsible for post market vigilance reporting, the proactive traceability of devices on the market and retention of device history documents.
AR responsibilities are non-transferable, but manufacturers may have an unlimited number of Product Licenses for the same device at the same time held by different ARs. Additionally, products registered under the new rules will be able to be imported by multiple distributors by using the license holders classification document, 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 to see if our VietNamese Independent License Holding service is right for your business.