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Vietnam Medical Device Labeling Requirements
Medical device labeling requirements in Vietnam are addressed by the Government of Vietnam (GVN) Decree 43/2017 On Goods Labeling. The Decree replaced previous guidance on goods labeling, Decree No. 89/2006. Per clause 2 article 10 Decree 111/2021, foreign manufacturers are able to import products with international labeling , international label of imported products must have:
- Model name
- Country of Origin (i.e. “Made in …”)
- Manufacture name & address
General Device Labeling Requirements
Local distributors must affix the following information to the products before delivering to the end user.
- Name of goods
- 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
- Warranty conditions
- 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.
Additional Labeling Compliance Notes
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.
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.
Vietnam Regulatory Support
US: +1 512 898-9222