Vietnam Medical Device Labeling Requirements

What Must Appear on Medical Device Labels in Vietnam?

All medical devices placed on the Vietnamese market must be labeled in Vietnamese or include a Vietnamese sub-label affixed to the product after customs clearance but before market distribution. At a minimum, labels should include:

• Name of the product

• Name and address of the responsible organization in Vietnam (typically the License Holder or importer)

• Country of origin

• Name and address of legal manufacturer

• Name and address of manufacturing facility

• Circulation number (if registered) or import license number

• Lot or serial number

• Warnings, storage instructions, and warranty information, either directly on the label or with clear instructions for locating this information.

• Date of manufacture and/or expiration date:

  • For devices that are sterilized, disposable, or involve reagents, control materials, or calibration substances, the expiration date is mandatory.

  • For equipment and machinery, the manufacturing year or month/year must be provided.

For foreign manufacturers, the product can be imported using the original international label, if it includes the product name, the origin, and the foreign manufacturer's name and address (Decree 37/2026/ND-CP). However, Vietnamese-compliant labeling must be applied before the product is put into circulation.

Medical Device Instructions for Use (IFU) Requirements in Vietnam

Most medical devices distributed in Vietnam are required to include Instructions for Use (IFU) to ensure safe and effective operation by healthcare professionals or end users. The IFU should include intended use, operating instructions, warnings, precautions, contraindications, maintenance guidance, storage conditions, and disposal instructions, if applicable.

IFUs must be provided in Vietnamese. A printed IFU is typically required; however, electronic IFUs (eIFUs) may be acceptable for certain low-risk devices or software products, as long as users are clearly directed to the digital version via labeling.

Distributors or Marketing Authorization Holders (MAHs) are responsible for ensuring that the IFU is both accurate and compliant with current regulations. IFUs are considered part of the device’s regulatory documentation and may be reviewed during audits or post-market inspections.

Imported labels, translation and release control

Before shipment, verify the current import-label requirements for the product name, manufacturer and origin, then plan any required Vietnamese supplementary label before circulation. The supplementary text must remain consistent with the original label, registered product and underlying evidence. Confirm the applicable general goods-labeling provisions and device-specific requirements through the Ministry portal; customs clearance alone does not establish permission for commercial circulation.

Maintain a requirements matrix covering each packaging level and the IFU. Record the local holder, model identifiers, authorization information, intended purpose, user, warnings, storage, sterility, expiry and traceability as applicable. A translation must preserve the approved clinical claims and limitations instead of adding new indications.

Keep approved artwork, translation review and release records under version control. Reassess classification and grouping when claims change, and review the change-filing requirements before using revised material. For electronic instructions, verify eligibility, reliable access and any mandatory physical content rather than assuming a QR code replaces the full IFU.

For regulatory terminology and the authority framework, see the Vietnam Ministry device authority.