Vietnam Local Labeling Requirements: Mandatory Vietnamese and Secondary Labeling After Customs

Vietnam Local Labeling Requirements: Mandatory Vietnamese and Secondary Labeling After Customs

Medical device labeling in Vietnam is primarily governed by Decree 43/2017 On Goods Labeling and its subsequent amendment, Decree 111/2021. While the international labeling is required for customs clearance, strict local regulations require that all necessary information be provided in Vietnamese before the product is delivered to the end user.

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Labeling for Customs Clearance

For customs clearance, foreign manufacturers are permitted to use their international labeling, provided it includes the following minimum information as per Decree 111/2021:

• Model Name
• Country of Origin (e.g., “Made in …”)
• Manufacturer Name & Address

Mandatory Local Labeling (Secondary Label)

After the product has cleared customs, the local distributor or the Market Authorization (MA) License Holder is responsible for affixing a secondary label or sub-label that provides all mandatory information in Vietnamese. This must be completed before the product reaches the end user.

The local label must include, but is not limited to, the following details:

1. Name of goods (Product Name)
2. Name and address of the enterprise responsible for the goods (License Holder/Importer)
3. Origin of goods
4. Circulation number or Market Authorization (MA) License number
5. Lot number or serial number
6. Date of manufacture, expiration date (mandatory for sterile/disposable devices, reagents, etc.)

Note on IFU: Instructions for Use (IFU) for certain low-risk devices and software labeling are permitted to be provided online, which is an exception to the physical labeling rule.

Multi-Tiered Labeling Compliance

The requirements of Circular 05/2019/TT-BKHCN define that labeling must be applied to the level of packaging intended for sale to the final customer.

• If a carton contains 10 boxes, and each box is sold separately to a consumer, both the carton and each individual box must be labeled.
• If there are 100 individually packaged items within a box, and each item is sold separately, three levels of labeling are required: the carton, the box, and each individual piece.

The Independent License Holder plays a critical role in ensuring all secondary labeling is correctly applied after importation, including listing their name and address on the Vietnamese label.