The Vietnamese government has issued Decree No. 37/2026/ND-CP (detailing the Law on Product and Goods Quality), fully replacing Decrees 43/2017/ND-CP and 111/2021/ND-CP and imposing stricter transparency and traceability requirements on medical device labeling. The new rules take effect on 1 July 2026, and medical device manufacturers, importers and distributors need to start reviewing and updating their existing packaging and labeling SOPs immediately.
1. Original Labels and Vietnamese Supplementary Labels
Imported medical devices with original labels in English or other foreign languages must meet the following minimum requirements:
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The original label must clearly show the product name, country of origin and the manufacturer’s name and address
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If the original label does not meet the mandatory Vietnamese content requirements, the importer must affix Vietnamese “Supplementary Labels”
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Supplementary labels must accurately translate all mandatory information and must not cover key mandatory content on the original label
2. Core Labeling Requirements: Five Categories of Mandatory Information
Labels of all medical devices circulating in Vietnam must include the following five categories of mandatory information:
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Circulation Number or Import License Number
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Lot Number or Serial Number
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Date of Manufacture and Expiry Date – sterile devices, single-use devices, IVD reagents, calibrators, control materials and chemicals must show an expiry date; other routine devices may show either the date of manufacture or the expiry date; large equipment must show the year or year and month of manufacture
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Warnings, instructions for use and storage guidance – may be printed directly on the label; where space is insufficient, the label must clearly indicate how to access them (e.g. an eIFU link)
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Warranty facility information (if applicable)
3. Labeling Details: Date Format and Font Size
Vietnamese customs and market surveillance authorities strictly review label layout; the new rules set the following hard standards:
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Font size and legibility: all mandatory information must be readable with the naked eye; the minimum font size on small-item labels is 0.9 mm, and text must contrast clearly with the background
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Date format: the Gregorian calendar in “day/month/year” format, with abbreviations allowed: NSX (date of manufacture), HSD (expiry date), HD (best before), e.g. NSX: 02/04/26 / HSD: 02/10/28
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Flexibility for imports: original foreign-language dates may be retained, but the Vietnamese information must clearly indicate which corresponds to DOM (Date of Manufacture) and EXP (Expiry Date)
4. Label Placement Requirements
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Where there is outer packaging and individual units are not sold separately, the label must be placed on the outer packaging
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Where individual units are sold separately, both outer and inner packaging must be labeled
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Where the outer packaging is transparent and the inner label information is clearly visible, repeated labeling of the outer packaging is exempted
5. Transitional Arrangements: Grandfather Clause
The new rules include a grandfather clause: existing stock produced or imported earlier can continue to circulate without retroactive correction. Note, however, that this exemption only applies to products manufactured or imported before the new rules take effect; new submissions being prepared or planned must comply with the new rules immediately – do not count on the exemption for extra time.
6. Recommended Actions
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Review models on sale: check all SKUs exported to Vietnam and confirm that the Vietnamese supplementary labels fully cover the five categories of mandatory information
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Review packaging design: for small consumables, work with packaging engineers to measure whether label fonts meet the 0.9 mm minimum, to avoid being judged non-compliant on font size
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Coordinate with your local agent: confirm with your Vietnamese authorized representative (AR) or importer the specific SOP for affixing supplementary labels, ensuring accurate translation and that key original label information is not covered
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Check date formats: verify that dates on existing labels follow the required “day/month/year” format and NSX/HSD abbreviations, especially for products that previously used US or other date formats
Tip: the label is the product’s “ID card” for customs clearance and lawful marketing. These new rules coincide with the Vietnamese MOH tightening registration requirements for Group 2 medical devices; we recommend planning label compliance review together with product registration pathway assessment, to avoid timing mismatches from working on them separately.
If you need a gap analysis of Vietnamese labeling compliance for specific products, or help designing supplementary label templates that meet the new rules, contact us – the EVERBIZ team will provide professional advice based on your products.