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.
Circular 05/2019/TT-BKHCN provides labeling guidance depending on how the product is sold. Products sold to the final customer will only need a label for the box or container, even if there are 100+ pieces inside. However, if there’s a carton of 10 boxes and each box is intended to be sold separately to different consumers, there will need to be labeling on the carton and on each individual piece. Furthermore, if there is also a 100 items within each box, then there will need to be 3 levels of labeling, on each carton, on each box and then on each individual piece that will be sold separately.
Customs Clearance will only require the original label which includes the model name, catalog number, manufacturer name, and, manufacturer location. Translated sub labels will then need to be applied once through customs and will include the name of the License Holder and Importer.
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.