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Labelling

All medical devices placed on the Vietnamese market must carry labels and instructions for use (IFU) that comply with Decree 98/2021/ND-CP and applicable labelling regulations. A key Vietnam-specific requirement is the Vietnamese-language labelling obligation.

Vietnamese-language labelling requirement​

All medical devices sold in Vietnam must carry labelling in Vietnamese. For imported devices, this is most commonly achieved through a supplementary label (nhãn phụ) — an additional label in Vietnamese affixed to the device or its packaging alongside (or over) the original foreign-language label.

Supplementary label (nhãn phụ) rules​

The supplementary label must:

  • Be affixed before or at the time of placing the device on the Vietnamese market
  • Include all the mandatory information listed below
  • Not obscure the original label information required by the country of manufacture
  • Be durable and clearly legible

Mandatory label information​

Labels for medical devices in Vietnam must include:

  • Name and intended use of the device
  • Name and address of the manufacturer
  • Name and address of the Vietnamese Authorised Representative (or importer)
  • Declaration or registration number (Số công bố / Số đăng ký lưu hành)
  • Batch/lot number or serial number (for traceability)
  • Date of manufacture and expiry date (if applicable)
  • Storage conditions (if special conditions apply)
  • Sterility indication (if supplied sterile) and single-use designation (if applicable)
  • Country of manufacture
  • Warning and precautionary statements relevant to the intended use

Instructions for Use (IFU)​

An IFU in Vietnamese must accompany the device and include:

  • Detailed description of intended purpose and indications
  • Contraindications and warnings
  • Instructions for correct use
  • Maintenance and cleaning instructions
  • Information on residual risks and safety precautions
  • Information for ordering and spare parts (if applicable)

Some simple devices may have IFU information incorporated on the label itself rather than a separate document.

Labelling for sterile devices​

Sterile devices must indicate:

  • The method of sterilisation
  • The single-use nature (if applicable)
  • "DO NOT USE IF PACKAGING IS DAMAGED" or equivalent warning
  • Re-sterilisation instructions (if permitted) or indication that re-sterilisation is not permitted

Prohibited claims​

Vietnamese consumer protection and health advertising law prohibits claims on medical device labels or promotional materials that are:

  • False or misleading about the device's capabilities or safety
  • Unsubstantiated by clinical evidence
  • Comparative (claiming superiority over named competitors) without substantiation
  • Suggesting a device can cure conditions beyond its licensed indications
Prepare labels early in your registration timeline

Vietnamese-language labelling must be submitted as part of the registration dossier. Prepare draft labels early and have them reviewed by your Authorised Representative or a Vietnamese regulatory specialist to avoid late-stage rework.

Supplementary labels may be affixed directly to the device itself, primary packaging, or secondary packaging—whichever is most visible to the user. Supplementary labels should not completely obscure or replace the original manufacturer's label unless the original foreign-language label is itself on an area covered by the Vietnamese supplementary label. For multi-language labels, ensure all mandatory information in Vietnamese is present on either the primary label or a clearly associated supplementary label.

Instructions for Use must be presented in a font size and format that is clearly legible to the intended user population. For devices intended for use by elderly patients or in low-light clinical environments, font size should be at least 8-10 pt. Complex technical information should be accompanied by diagrams or illustrations to enhance clarity.