Name and address of the enterprise responsible for the goods
Origin of goods
Circulation number or import license number
Lot number or serial number
Date of manufacture, expiration date (sterilized or disposable medical equipment, reagents, calibration substances, control materials, chemicals require an expiration date)
Instructions for use
Instructions for storage
Other details in conformity with the nature of the goods prescribed in Appendix I of Decree 42/2017 and other relevant legal documents.
Instructions for Use (IFU) for certain low risk devices and labeling for software can be provided online.
All products must be labeled in Vietnamese. Country specific labeling, included the Vietnamese translation of the original label, can be affixed as a secondary label in Vietnam after importation.
The manufacturer is charged with labeling goods for domestic circulation. Independent License Holders, like Asia Actual, can affix secondary labels to imported products. If using an Independent License Holder, the name and address of the License Holder must be listed on the label.
Contact Asia Actual to see if our Vietnam labeling solutions are right for your needs.