Vietnam 2026 Medical Device Labeling Requirements

Vietnam's Decree 37/2026/ND-CP took effect on 23 January 2026, its signing date, under article 97(1). The decree implements the Product and Goods Quality Law and includes goods-labeling rules in articles 34–54. Article 97(4) repeals Decree 43/2017/ND-CP and its amending Decree 111/2021/ND-CP from that date.

The official register distinguishes the effective date from later publication of the document. Article 97(3)'s separate continuation of older product-quality classification measures through 30 June 2026 does not defer the labeling chapter to July.

Mandatory content for medical devices

Article 42(1) requires labels for goods circulating in Vietnam to provide the product name, the name and address of the responsible organization or individual, origin, and the additional information applicable to the product category. Vietnamese-language requirements are subject to the exceptions in article 39 and applicable specialist law.

For medical devices, item 13 of Annex I adds:

• The circulation number or medical device import-license number.
• The lot number or serial number.
• Manufacturing and expiry information according to device type. Sterile devices, single-use devices, reagents, calibrators, control materials and chemicals must show expiry information. Other cases may show manufacture or expiry dates; machinery and equipment show the manufacturing year or month and year.
• Warnings, instructions for use, storage instructions and warranty-service information. The annex permits this information on the label or clear directions on the label for looking it up.

These category requirements must be read together with the general label content. A circulation number alone does not replace the product name, responsible-party details or origin.

Packaging, legibility and small labels

Article 36 distinguishes products sold only in outer packaging from inner units also sold separately. Where the inner units are sold separately, both the outer and immediate packaging must carry the required labeling. Transparent outer packaging need not carry an additional label when the inner labeling is visible, subject to the article's conditions.

Article 37 requires characters readable with the naked eye. Its 0.9 mm reference is part of the test for small goods or packaging that cannot accommodate all mandatory content; it is not a blanket permission to shrink every device label to that size. In the specified small-package cases, core information remains on a physical label and other information may be provided in accompanying documents or an electronic label. Imported small goods have a separate physical-label requirement under article 37(4). Article 38 requires mandatory information to contrast with the label background.

Original and supplementary labels for imports

At customs clearance, article 42(2) requires physical original-label information in Vietnamese or a foreign language: the product name, origin or the permitted alternative where origin cannot be determined, and identification of the overseas manufacturer or responsible organization or individual. The article allows specified missing name-and-address details in accompanying documents or shipment records.

Before goods with foreign-language original labels enter the Vietnamese market, the importer must add the required Vietnamese content. Under article 40, supplementary labeling must preserve the original label and must not obscure its mandatory information. It translates mandatory content and adds required information that is missing. Article 40(4) also provides defined exceptions, including certain non-market components and samples; those exceptions should be checked against the actual import purpose.

Transitional stock and preprinted labels

Article 98 creates conditional transition arrangements:

1. Goods whose labels comply with Decrees 43/2017 and 111/2021 and that were manufactured, imported, circulated or used before 23 January 2026 may continue circulating and being used until the expiry date on their labels.
2. Labels and labeled commercial packaging produced or printed before the effective date in compliance with those earlier decrees may continue to be used for no more than two years from the effective date.

These provisions do not exempt all older devices regardless of label compliance. They also distinguish the circulation of already labeled goods from continued use of preprinted label stocks.

Practical labeling review

Pure Global recommends reviewing each device's artwork against article 42 and Annex I item 13, documenting which transition condition applies to older inventory or preprinted packaging, and confirming who supplies Vietnamese supplementary content before market circulation.

Article 41 assigns responsibilities by role. Its five-year minimum retention requirement in paragraph 6(c) applies to e-commerce platform operators and the platform data specified there; it is not a general five-year record-retention rule for every medical device manufacturer, importer or distributor.

For market-access context, see our Vietnam medical device registration page and classification and grouping guide.

Correction, 5 September 2026: this article previously stated 26 January 2026 as the effective date and described the transition too broadly. The date is 23 January 2026. The article now states the conditions for older stock and preprinted labels and corrects the scope of the small-label and platform record-retention provisions.