Vietnam has issued Decree 37/2026/ND-CP, updating medical device labeling requirements for both domestic and imported devices. The decree clarifies mandatory labeling content, including circulation numbers, lot numbers, dates of manufacture and expiry, warning information, instructions for use, storage instructions, and supplementary labeling for foreign-language imports.
Key Dates: The new labeling requirements take effect from January 26, 2026. Medical devices already in Vietnam or manufactured before this date do not need to comply with the new guidelines.
Compliance is essential for manufacturers, importers, and distributors to ensure safe and legal circulation of medical devices in Vietnam.
Key Updates in Decree 37/2026/ND-CP
Decree 37/2026/ND-CP replaces previous regulations under Decree 43/2017/ND-CP and Decree 111/2021/ND-CP. It introduces new labeling rules aimed at improving consumer safety, traceability, and transparency of goods, including medical devices. Key updates relevant to medical devices include:
- Position of Labels: Labels must appear on outer packaging if individual units are not sold separately. Both outer and immediate packaging must be labeled if individual units are sold separately. Transparent outer packaging may not require additional labeling if internal information is visible.
- Size and Legibility: All mandatory information must be fully displayed. Fonts must be readable with the naked eye; minimum font size is 0.9 mm for small-sized goods.
- Colors and Contrast: Letters, numbers, images, and symbols must be clearly visible, with mandatory information contrasting the background.
- Language Requirements: Vietnamese is mandatory on labels for the domestic market. Foreign-language original labels require a Vietnamese supplementary label that reflects all mandatory content accurately.
Labeling Requirements for Domestic and Imported Medical Devices
All medical device labels in Vietnam must include:
- Circulation Number or Import License Number
- Lot Number or Serial Number
- Date of Manufacture and Expiry Date:
- Sterile devices, single-use devices, reagents, calibrators, control materials, and chemicals must show expiry date.
- Other medical devices may indicate either date of manufacture or expiry date.
- Devices that are machinery or equipment must show year or month and year of manufacture.
- Warning Information, Instructions, and Storage Guidelines: These may appear directly on the device label or indicate where to access them.
- Warranty Facility Information: If applicable.
Original and Supplementary Labels for Imports
For imported medical devices:
- The original label must show the product name, origin, and manufacturer’s name and address in the foreign language.
- If the original label does not show complete information, the importer must add a Vietnamese supplementary label.
- Supplementary labels must not obscure mandatory information on the original label and should include all Vietnamese translations of mandatory content.
Date of Manufacture and Expiry Date Guidelines
Decree 37/2026/ND-CP requires precise formatting for dates:
- Format: Day, month, year (Gregorian calendar).
- Abbreviations allowed: “NSX” (date of manufacture), “HSD” (expiry date), or “HD” (use-by date).
- Flexibility for imports: Original foreign-language dates may remain, but instructions must clarify the corresponding DOM and EXP.
- Examples of acceptable formats:
- DOM: 020426 / EXP: 021028
- DOM: 02/04/26 / EXP: 02/10/28
- DOM: 02042026 / EXP: 02102028
Compliance Steps for Medical Device Manufacturers
To ensure compliance with Vietnam’s 2026 labeling regulations:
- Verify all mandatory label contents are included in Vietnamese.
- Add supplementary labels for imported devices with foreign-language labels.
- Ensure legibility, size, and color contrast meet regulatory requirements.
- Accurately indicate date of manufacture, expiry date, and origin.
- Maintain records of labeling, certificates, and product data for at least 5 years for inspection or dispute resolution.
- Note transitional provisions: Products manufactured or imported before January 26, 2026 do not need to follow the new labeling rules.
Impact on Medical Device Circulation
Complying with Decree 37/2026/ND-CP ensures:
- Legal circulation of medical devices in Vietnam
- Improved traceability and accountability
- Reduced risk of regulatory penalties
- Clear guidance for labeling small-sized goods and packaging
- Transitional clarity for existing stock
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