Medical Device Labelling in Vietnam

Medical-device labels in Vietnam must satisfy two layered regimes:

1. General goods labelling — Decree 37/2026/NĐ-CP (issued and in force 23 January 2026) consolidates and replaces Decree 43/2017/NĐ-CP and Decree 111/2021/NĐ-CP. Article 36 governs label position (must be identifiable without disassembly); Article 42 sets the mandatory Vietnamese-language content and product-category-specific requirements in Appendix I. 2. Medical-device-specific labelling — Decree 98/2021/NĐ-CP (Articles on management, labelling and post-market obligations), as amended by Decree 07/2023/NĐ-CP, Decree 96/2023/NĐ-CP and Decree 04/2025/NĐ-CP; Circular 05/2022/TT-BYT provides implementation detail alongside AMDD-aligned classification in Circular 19/2021/TT-BYT.

The device-specific framework was not changed by Decree 37/2026: Circular 05/2022 remains operative for device-specific rules on registration-number display, e-IFU, symbols and post-market vigilance. On-label content must satisfy both frameworks.

A compliant medical-device label must show, in Vietnamese (or with a Vietnamese supplementary label for imports):

Mandatory primary information (narrative):

• Device name and intended use — the trade name as declared in the registration dossier, plus the intended-use statement approved by DMEC (Bộ Y tế — Vụ Trang thiết bị và Công trình y tế / IMDA). The intended-use text on the label must match the registered indication verbatim; deviation is a common cause of post-market recall.
• Registration-holder (chủ sở hữu số lưu hành) — name and address of the Vietnamese legal entity that holds the Marketing Authorisation Certificate (MAC) or is named on the Class A published declaration.
• Manufacturer — full or abbreviated name and full address of the actual manufacturing site (abbreviation permitted per Decree 37/2026); if the manufacturer is not the registration holder, both must appear.
• Country of origin — Made in [country] / Xuất xứ, reflecting the substantial-transformation origin. Decree 37/2026 continues the substantial-transformation test carried over from Decree 111/2021 and permits country-name abbreviations per Vietnam Standard TCVN 7217-1.
• Registration number (Số lưu hành) — for Class B/C/D, the MAC number issued by DMEC in the form NNNNNN/BYT-CCHCTBYT; for Class A, the published-declaration number issued by the provincial Sở Y tế. This is the primary device identifier on the Vietnamese market and must be printed on the immediate package.
• Lot / batch number (Số lô SX) and manufacturing date (NSX), in a format traceable to the manufacturer's production records; expiry date (HSD) where the device has a defined shelf life; unique serial number for capital equipment. Decree 37/2026 formalises the NSX / HSD abbreviations and requires day-month-year (Gregorian) formatting.
• Storage conditions and use environment — temperature, humidity, shielding, single-use vs reusable, sterile vs non-sterile; sterilisation method (EO, gamma, steam) where applicable.
• Symbols and warnings — CE / ISO 15223-1 harmonised symbols are accepted alongside the Vietnamese text; safety warnings and contraindications required by the technical file must appear in Vietnamese on either the label or the immediate accompanying IFU.
• Instructions for use (IFU / tờ hướng dẫn sử dụng) — must be in Vietnamese for devices intended for lay use; for professional-use devices, the IFU may be in Vietnamese plus a second working language.
• Minimum legibility — Decree 37/2026 sets a 0.9 mm minimum font size for on-package content; smaller devices must move the required content to the outer commercial packaging.

Supplementary label for imports (nhãn phụ): per Decree 37/2026/NĐ-CP (carrying forward the rule from Decree 43/2017 + Decree 111/2021, Article 10), imported devices bearing an original foreign-language label may attach a Vietnamese supplementary label before customs clearance or at the first point of distribution. The supplementary label must cover every mandatory item that is not already in Vietnamese on the original label, including the registration number, registration holder, intended use, warnings, and Vietnamese IFU or a clear pointer to it. The supplementary label must not obscure the mandatory information already on the original.

Identifier convention (UDI-adjacent): Vietnam does not currently operate a national UDI system in the FDA/EU-MDR sense. The Số lưu hành issued at registration serves as the primary regulatory identifier on the Vietnamese market and must appear on the label and in customs declarations; the manufacturer's own catalogue/model number and lot number are what the post-market vigilance and recall systems track. Devices carrying a GS1/HIBCC barcode from their home market may keep it — but the Vietnamese identifier is the authoritative one for enforcement.

Electronic labels and electronic IFU:

• Electronic label (Decree 37/2026): for the first time, general goods may display label content in electronic form via a data carrier (QR, barcode, RFID, NFC) affixed to the product or commercial packaging. This e-label mechanism is not available for imported goods or for items where a specialised regulation requires a physical label — which effectively excludes most imported medical devices.
• Electronic IFU (Circular 05/2022/TT-BYT): the device-specific e-IFU allowance is separate from Decree 37/2026's general e-label rule. Circular 05/2022 permits an electronic instructions-for-use for professional-use devices where the IFU is (a) freely accessible online at a stable URL, (b) downloadable and printable, (c) available in the version corresponding to the device the user holds, and (d) the label includes a clear reference (URL or QR code) to the IFU. Devices intended for lay use — home-care equipment, self-test IVDs, wearable therapy — must ship with a printed Vietnamese IFU regardless.

Online product listings: Decree 37/2026 formalises and expands the online-listing rule introduced by Decree 111/2021: the same mandatory label content must appear on the product detail page when the device is sold online in Vietnam, in Vietnamese. Platforms may be required to remove non-compliant listings on notice from MOH or the provincial Sở Y tế.

Trademark symbol restriction (Decree 37/2026 change): the "®" symbol may only be used with a trademark that is actively registered in Vietnam. Using ® with an unregistered mark on a Vietnamese-market label is now an explicit non-conformance.

General label framework (current):

• Decree 37/2026/NĐ-CP — general goods labelling. Issued and in force 23 January 2026. Consolidates and replaces Decree 43/2017/NĐ-CP and Decree 111/2021/NĐ-CP. Article 36 (label position), Article 42 (mandatory Vietnamese content). Introduces e-label carrier support (with imports carve-out), 0.9 mm minimum font, ® symbol restrictions, and expanded e-commerce disclosure. Transitional provisions: products manufactured or imported before 23 January 2026 may circulate through end of shelf life; pre-printed labels issued before 23 January 2026 may be used for up to two years (until 23 January 2028).

General label framework (superseded 23 January 2026 — retained for reference to legacy labels):

• Decree 43/2017/NĐ-CP — labels of goods circulated in Vietnam. Issued 14 April 2017, effective 1 June 2017. Superseded by Decree 37/2026.
• Decree 111/2021/NĐ-CP — amended Decree 43/2017. Issued 9 December 2021, effective 15 February 2022. Superseded by Decree 37/2026.
• Circular 05/2019/TT-BKHCN — MoST implementation detail for Decree 43/2017. Applicability under the Decree 37/2026 regime pending re-issuance guidance.

Medical-device-specific framework (unchanged by Decree 37/2026):

• Decree 98/2021/NĐ-CP — foundational instrument for medical-device management; in force 1 January 2022. Labelling requirements apply alongside registration, import and post-market obligations.
• Decree 07/2023/NĐ-CP — first amendment to Decree 98; in force 3 March 2023.
• Decree 96/2023/NĐ-CP — second amendment; in force 15 January 2024.
• Decree 04/2025/NĐ-CP — third amendment; in force 1 January 2025.
• Circular 05/2022/TT-BYT — implementing details for classification, registration, labelling, recall and post-market vigilance; permits e-IFU for professional-use devices under specified conditions.
• Circular 19/2021/TT-BYT — classification rules under the AMDD framework.
• Circular 10/2023/TT-BYT — list of medical devices in Group 2 subject to specific management measures.

Symbols and technical standards:

• ISO 15223-1 — internationally harmonised symbols for medical-device labels (single-use, sterile, use-by, manufacturer, etc.); accepted alongside Vietnamese text.
• ISO 20417 — information supplied by the manufacturer of medical devices.
• ISO 13485:2016 — quality management system; the QMS covers label control and change management.
• TCVN 7217-1 — Vietnam Standard for country-name codes; referenced by Decree 37/2026 for country-of-origin abbreviations.

Penalty framework:

• Decree 117/2020/NĐ-CP — administrative penalties in the health sector, as amended by Decree 124/2021/NĐ-CP. Applies to medical-device labelling violations: fines for missing registration number on label, no supplementary label on imports, non-conforming intended-use statement, missing Vietnamese IFU on lay-use devices, and online listings that do not carry mandatory label content.

Note on numbering: Decree, Circular, and Resolution numbers and effective dates should be verified against the official publication on the MOH portal (moh.gov.vn), the Official Gazette (Công báo), or the National Legal Database (vbpl.vn) before relying on them.

2026 — Decree 37/2026/NĐ-CP takes effect (23 January 2026):

• The new general-goods labelling framework consolidates and replaces Decree 43/2017/NĐ-CP and Decree 111/2021/NĐ-CP in a single instrument. For medical devices this affects the general-goods layer of the label; the device-specific rules in Decree 98/2021 (as amended) and Circular 05/2022/TT-BYT are unchanged.
• Substantive changes relevant to medical-device labels: introduction of an electronic-label mechanism via QR / barcode / RFID / NFC (excluded for imports and for items with a specialised physical-label requirement — effectively excluding most imported medical devices); a 0.9 mm minimum font size for on-package content; formalisation of NSX / HSD abbreviations and day-month-year date format; explicit ® symbol restriction (only allowed with a Vietnam-registered trademark); permission to use abbreviated manufacturer name and country-of-origin codes per TCVN 7217-1; expanded e-commerce listing obligations.
• Transitional provisions: products manufactured or imported before 23 January 2026 may continue to circulate through the end of their shelf life; pre-printed labels issued before 23 January 2026 may continue to be used for up to two years (until 23 January 2028).

Decree 04/2025 impact on labelling (unchanged in force since 1 January 2025):

• The third amendment to Decree 98/2021 preserves the labelling framework of Circular 05/2022/TT-BYT but tightens the correspondence between the registered intended-use statement and the on-label wording. Post-market inspections in 2025 flagged label variations that broaden the intended-use beyond the registered indication as a primary non-conformance.
• Transitional rules from Decree 07/2023 and Decree 96/2023 for Decree 36-era MAC certificates ran through 31 December 2024. Devices still carrying pre-Decree-98 label content are being progressively re-labelled at renewal.

Common labelling gaps in 2024–2025 inspections (DMEC / provincial Sở Y tế reports):

• Registration number missing from the immediate package on imported devices — importers relying on the Vietnamese supplementary label alone. The registration number must be on the immediate package.
• Intended-use statement on the label softened or broadened relative to the registered indication (e.g., adding "and general wellness monitoring" to a device registered as a specific vital-sign monitor).
• Electronic IFU URLs going stale, or version mismatch between the URL content and the device on shelf.
• Online listings that carry only marketing copy and omit the required Vietnamese mandatory content.

E-IFU acceptance:

• Adoption of e-IFU (Circular 05/2022 mechanism, separate from Decree 37/2026's general e-label) has accelerated for high-value diagnostic and hospital equipment where paper IFUs run to hundreds of pages. Auditors expect the URL to resolve, the PDF to be a controlled document with a version code visible on the device label, and the download not to require registration or payment.

Country-of-origin under the 2026 regime:

• "Made in [country]" on medical devices must reflect substantial transformation. Devices merely assembled or repackaged in a country do not qualify to bear that country as origin. Decree 37/2026 carries this rule forward from Decree 111/2021 and permits abbreviations per TCVN 7217-1; the manufacturer's declaration in the registration dossier is the reference point.