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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.