Medical device distribution in Vietnam
Only registered medical devices may be distributed in Vietnam, that means they must be registered with the Department of Medical Equipment and Construction (DMEC) of the Vietnamese Ministry of Health (MoH) and been issued with a Notification of Applicable Standard or Circulation Registration Certificate also known as the Product License unless exempted from registration (see below). All medical devices and in-vitro diagnostics that are in circulation in Vietnam as well as those that are exported are listed in the DMEC portal system.
Who can distribute medical devices in Vietnam?
What are the requirements for distributing medical devices in Vietnam?
Advertising, communication and promotion of medical device is a common part of a distribution contract. In Vietnam, the promotion and marketing of medical devices must comply with Decree 181/2013/NĐ-CP concerning advertisement law and Circular 09/2015/TT-BYT regulating the marketing and advertising in medical sections. Only the License Holder or those entities who are authorized by the License Holder may submit applications to the DMEC for approval prior to the promotion and marketing of medical devices. The contents of promotion and advertising must be consistent with the Free sale Certificate of domestic medical devices and the Product License/Import License of medical devices.
Distributor’s duties and obligations
It is mandatory for distributors of medical devices and IVDs to Vietnam to store the following quality control documents:
Distributors must also:
How Andaman Medical can help with distributing medical devices to Vietnam:
Andaman Medical holds a valid license to operate as an importer and master distributor of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import and distribute medical devices and IVDs. We remain independent from any final distribution channel partner you choose to appoint, giving you freedom in your distribution strategy, you may even appoint multiple distributors. Our regulatory affairs specialists and logistics executives will help you to: