Vietnam medical device and IVD post-market requirements

Device change notification requirements in Vietnam

Changes on Decree 98's notifiable list are self-notified to the authority — a ten-working-day mechanism with no approval step — while substantive changes require a new registration application. 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. On a warning of potential serious risk, license holders must notify affected healthcare facilities and complete the investigation within 30 days of becoming aware of it; adverse events resulting in user harm, serious public-health threats, or death must be reported to the authorities under the vigilance procedures.

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.

Regulatory authority and source of truth

This service sits within the current requirements administered by the relevant regulator. Use that glossary entry for the authority's remit, official portal, and contact points; use this page for the task-specific workflow and deliverables.