On January 23, 2026, Vietnam announced an update to the labeling requirements for both domestic and imported medical devices. These requirements have been in effect since January 26, 2026. All medical devices imported into or manufactured in Vietnam after this date must comply with the new labeling requirements.
The main revisions are as follows.
1. Placement of product labels
- if the product has only outer packaging, the label must be affixed to the outer packaging.
- if the product is sold with both inner and outer packaging, labels must be affixed to both.
- for transparent outer packaging where the inner label is visible, labeling on the outer packaging is not mandatory.
2. Size of labels and front/number size on labels
- all mandatory information must be printed in a front size of at least 0.9mm.
3. Color of text, symbols, and images on labels
- text, numbers, images, symbols, and graphics printed on the label must be clearly legible. For information required by regulations, the color must contrast with the background of the product label.
4. Labeling language
- products distributed in the Vietnamese market must be labeled in Vietnamese.
- imported products may retain the original label in a foreign but must have an additional label in Vietnamese displaying all mandatory information.
Please refer to the attached document below.
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