Medical Device Labelling in Vietnam

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

1. **General goods labelling** — Decree 43/2017/NĐ-CP on labels of goods circulated in Vietnam, as amended by Decree 111/2021/NĐ-CP; Circular 05/2019/TT-BKHCN provides implementation detail. 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.

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

**Mandatory primary information:**

• **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** — name and full address of the actual manufacturing site. If the manufacturer is not the registration holder, both must appear on the label.
• **Country of origin** — Made in [country] / Xuất xứ, reflecting the substantial-transformation origin per Decree 111/2021, not the assembly or repackaging country.
• **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.
• **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.

**Supplementary label for imports (nhãn phụ):** per Decree 43/2017 as amended by 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.

**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 IFU (e-IFU):** Circular 05/2022/TT-BYT allows 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:** per Decree 111/2021, Article 12 as amended, 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.

General label framework:

• Decree 43/2017/NĐ-CP — labels of goods circulated in Vietnam. Issued 14 April 2017, effective 1 June 2017.
• Decree 111/2021/NĐ-CP — amends Decree 43/2017. Issued 9 December 2021, effective 15 February 2022. Clarifies supplementary-label rules for imports, country-of-origin rules, and online-listing content.
• Circular 05/2019/TT-BKHCN — detailed guidance on label content under Decree 43/2017.

Medical-device-specific framework:

• 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.

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.

Decree 04/2025 impact on labelling:

• The third amendment to Decree 98/2021 (in force 1 January 2025) 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 (older MAC prefix, older intended-use phrasing) 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 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 Decree 111/2021:

• "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. This has affected labelling for regional assembly hubs; the manufacturer's declaration in the registration dossier is the reference point.