Clinical Trials The DMEHW typically will grant an import license within 15 working days of receiv

Clinical Trials

The DMEHW typically will grant an import license within 15 working days of receiving an application dossier, unless clinical trials are required. This may be the case if a medical device has a new function, a new therapy, or is the first of its type to be imported into Vietnam.

Foreign clinical trials can be accepted for registration, but they also must have been accepted by the foreign country’s medical regulatory agency and be registered in the country of origin. Also, the MOH’s Science and Technology Council must examine and approve the foreign clinical trial results.

If the MOH decides that local clinical trials also must be conducted in Vietnam for the product to be approved, the manufacturer or distributor will not be the sponsor of the trials. Rather, the MOH will organize and conduct the trials itself, typically in three or more hospitals. Depending on the product being tested, trials may take three to 12 months to complete or more, in some cases.

If local clinical trials are required, and no trials have been performed inside or outside of Vietnam, the DMEHW will arrange them. The applying company is responsible for preparing clinical trial protocols. At the end of the trial, the hospitals will pass the results back to the DMEHW and the applicant. The applicant then should resubmit the application with the trial results. The DMEHW will issue its decision within another 15 working days.