Vietnam Medical Device Labeling Requirements
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.
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 device model name, manufacturer name and address, and country of origin. However, Vietnamese-compliant labeling must be applied before the product reaches the end user.
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.
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Frequently asked questions
The number of required label levels depends on how the product reaches the final customer. For example, a box of test strips sold to a hospital only needs one label on the outer box. However, if individual boxes or units with a box or crate are sold separately, then each box or unit must be labeled in addition to the outer box.
Yes, for some device types. Vietnam allows electronic labeling for certain low-risk medical devices and software products. However, physical labeling must still direct users to the location of the digital IFU or relevant warnings. It is important to confirm eligibility on a case-by-case basis and ensure any web-hosted content is available in Vietnamese.
Any significant device changes that would warrant a label update (such as the manufacturer name, intended use, expiration date, or warnings) may require notification to the Ministry of Health and an update to your registration certificate. Minor updates (e.g., formatting or layout changes) generally do not, but it’s advisable to consult with your License Holder or regulatory partner to assess the impact.
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