Post-Market Overview
Overview of ongoing post-market obligations for medical devices placed on the Vietnamese market under Decree 98/2021.
Incident Reporting & Vigilance
Medical device incident reporting obligations in Vietnam โ what to report, to whom, and within what timeframes under Decree 98/2021.
FSCA & Recalls
Field Safety Corrective Actions (FSCA) and recall procedures for medical devices in Vietnam, including notification to DAV and provincial health departments.
Post-Market Surveillance
Post-market surveillance (PMS) requirements for medical devices in Vietnam โ PMS plans, complaint handling, trend analysis, and periodic reporting.
Labelling
Medical device labelling requirements in Vietnam โ Vietnamese-language labels, supplementary labels (nhรฃn phแปฅ), IFU requirements, and prohibited claims.
Change Notification
How to notify DAV of changes to declared or registered medical devices in Vietnam โ significant vs minor changes and the applicable procedure.