Medical device labeling requirements in Vietnam are governed by Decree 43/2017/ND-CP on Goods Labeling, along with additional regulations that apply specifically to medical devices. The manufacturer is responsible for preparing the product label.
However, a legal in-country representative called a Marketing Authorization Holders (MAHs) usually manages labeling for manufacturers located outside Vietnam to ensure compliance with labeling requirements. In this case, the MAH name and address must also appear on the Vietnamese label.
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.
