Classification Overview
How the Vietnamese Type A–D classification system works and how it aligns with the ASEAN Medical Device Directive.
Type A & B Devices
Examples and classification criteria for Type A (lowest risk) and Type B (low-to-medium risk) medical devices in Vietnam.
Type C & D Devices
Examples and classification criteria for Type C (medium-to-high risk) and Type D (highest risk) medical devices in Vietnam.
IVD Classification
How in-vitro diagnostic devices are classified in Vietnam under the Decree 98/2021 framework.
Combination Products & Borderline Devices
How Vietnam regulates combination products and devices that sit on the boundary between medical devices and medicines or other regulated products.