What regulations inform Vietnam medical device classification?
Classification of medical devices and in vitro diagnostic (IVD) medical devices is regulated by the Infrastructure and Medical Device Administration (IMDA) under the framework of Decree No. 98/2021, which came into effect on January 1, 2022. This regulation aligns with international standards, including the ASEAN Medical Device Directive and Global Harmonization Task Force (GHTF) classification guidance. Circular 05/2022 provides additional guidance on the classification of medical devices and IVDs, as well as lists of device types that have specific market entry requirements or exemptions.
How are devices classified in Vietnam?
A medical device in Vietnam includes instruments, implants, materials, reagents, software, or in vitro calibrators that are used—alone or in combination—for human health purposes such as diagnosis, prevention, monitoring, treatment of disease or injury, supporting physiological functions, sustaining life, sterilization, or providing diagnostic information through specimen testing.
Vietnam classifies medical devices into four risk-based classes:
- Class A – Low risk (e.g., surgical gloves, stethoscopes)
- Class B – Low-to-moderate risk (e.g., infusion pumps, thermometers)
- Class C – Moderate-to-high risk (e.g., ventilators, anesthesia machines)
- Class D – High risk (e.g., pacemakers, defibrillators)
The classification depends on several factors including intended use, duration of contact with the body, invasiveness, whether it is active or passive (i.e., does the device require a power source, such as a battery), and whether it supports or sustains life.
IVD Medical Devices Classification
In vitro diagnostic (IVD) devices are defined in Decree 98/2021 as a subset of medical devices used to test specimens from the human body and include reagents, analyzers, calibrators, and related systems. IVDs are also classified under the same risk framework (Class A, B, C, and D), with classification based on intended use (e.g., self-testing vs. professional use); risk to public health (e.g., tests for transmissible agents); and impact on patient management.
Medical device and IVD grouping in Vietnam
Medical devices and IVDs can be grouped and registered as one application to obtain one medical device registration certificate. Medical devices that apply for registration as a group must have the same intended use, legal manufacturer, and risk classification. Potential grouping categories include single devices, families, systems, sets, IVD test kits, and IVD clusters.
