Clinical Trials in Vietnam Required for First-Time Device Imports

Vietnam has recently moved to enhance its medical device regulatory system. While imported medical devices do not need to be registered in Vietnam to be marketed, they do require an import license. First-time device imports that use a novel method of diagnosis or treatment must go through clinical trials in at least three government-designated hospitals in Vietnam before they can apply for an import permit.

The Department of Medical Equipment and Health Works (DMEHW) will review the manufacturer’s application for clinical trials. If approved, the DMEHW will allow a certain number of devices to be imported solely for clinical trials. Once the trials are over, the manufacturer’s local representative can then submit trial results in the import permit application.

The DMEHW may decide that certain devices do not require in-country clinical trials if they are deemed safe and are approved for marketing in another country, but this is determined on a case-by-case basis.

As a member of the Association of Southeast Asian Nations (ASEAN), Vietnam also plans to adopt the Common Submission Dossier Template (CSDT) in the future, as well as a post-marketing surveillance system currently in development. These changes will harmonize its regulatory system with those of the other ASEAN member countries, who also plan to standardize their device regulatory systems.