Import License An important fact about medical device registration in Vietnam is that the basic p

Import License

An important fact about medical device registration in Vietnam is that the basic process is different for imported devices than for domestically manufactured devices. Technically, most imported devices do not need product registration, just an import license.

A dossier for a new import licenseincludes the following documents:

• The original product catalog;

• The instructions manual and technical specifications (enclosed with their Vietnamese translations) of each kind of device;

•A quality control certificate—ISO, U.S. Food and Drug Administration (FDA), European Commission (EC) —or equivalent;

• Free sales certificate from country of origin; and

• Quality declaration letter.

Foreign registration processing with the correct documentation—FDA or EC approval—is very rapid, with positive or negative responses usually given within three weeks.