Medical device importation to Vietnam
Only registered medical devices may be imported into 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 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.
What are the requirements for importing medical devices into Vietnam?
Are there any exemptions or exclusions?
Special Access Routes for importing medical devices into Vietnam
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Vietnam to store the following quality control documents:
Importers must also:
How Andaman Medical can help with importing medical devices to Vietnam:
Andaman Medical holds a valid license to operate as an importer of medical device and in-vitro diagnostics as well as being able to authorize other third parties to import medical devices and in-vitro diagnostics. 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: