Vietnam Medical Device and IVD Post-Market Requirements

Device change notification requirements in Vietnam

Changes expressly covered by the current notifiable categories follow their specified procedure and timing; other changes may require a different filing or new registration. Do not extend a ten-working-day notification mechanism to every product modification. 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 through the applicable holder and manufacturer duties, device traceability, and complete records. Manufacturer ISO 13485 evidence is distinct from the local holder’s distribution, storage and documentation responsibilities. Documentation retention requirements include maintaining hard‑copy records of the approved 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.

Maintain one product and safety record

Use the current Ministry requirements to classify each change before implementation. Record the approved version, proposed change, impact on safety/performance and intended purpose, applicable filing category, submission date and release decision. A labeling update that adds a clinical indication is not merely an administrative translation correction.

Keep distribution records capable of identifying affected customers and lots during a recall. Link complaint investigation and CAPA to the manufacturer’s risk-management file and to the holder's authority communications. Separate immediate action for serious harm from any permitted investigation or follow-up period; a 30-day investigation provision is not permission to postpone urgent notification.

For specified equipment, also assess the separate technical inspection duties and transition in Circular 24/2026/TT-BYT. Device registration, periodic equipment inspection and the holder's postmarket duties have different purposes. Coordinate labeling changes and registration scope so that the current product file remains consistent.

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