Device change notification requirements in Vietnam
Device changes typically require a formal amendment to the license before the modified product may be imported or sold. In some cases, a new registration application may be necessary. Understanding when an amendment is required is essential to avoid customs clearance delays, so consult with your MAH about how to handle specific amendment situations.
Changes that require an amendment can include a new license holder name or address, packaging changes, or updates to the labeling or Instructions for Use (IFU). If labeling or IFU changes address a change in the device’s intended use, a new registration application may be required.
To implement an amendment, the license holder must submit a notification letter accompanied by relevant supporting documents relevant to the change.
Quality management and device traceability requirements
MAHs are primarily responsible for product safety and quality at every stage of the product life cycle by maintaining a QMS (in compliance with ISO 13485), device traceability, and complete device records and documentation. Documentation retention requirements include maintaining hard‑copy records of the approved the registration dossier and supporting documents (e.g., the letter of authorization from the product owner and free‑sale certificate), plus distribution dossiers, batch‑specific certificates, accreditation results, and all post‑market documentation (adverse‑event logs, complaints, corrective actions, and disposal records).
Post‑market surveillance (PMS) and Vigilance
Post‑market surveillance of medical devices in Vietnam falls under MOH Decrees 98, which require MAHs to operate a structured PMS program that continuously collects performance data, investigates user feedback and nonconformities, and implements corrective and preventive actions, including recalls. All adverse event cases resulting in user harm, serious public‑health threats, or death, must be reported to authorities and affected healthcare facilities within 30 days.
When a device poses risk of death or serious health deterioration, license holders must immediately suspend its circulation, notify the Ministry of Health and distributors in writing, investigate root causes, execute corrective actions, and submit a final report. For non‑fatal but serious threats, they must still inform the MOH, carry out an investigation, and report findings.
