Medical device classification is the process of determining the risk level of a medical device based on its intended use and the potential impact on patient health.
In Vietnam, medical devices are typically classified into four groups:
Class A (low risk): Simple devices with minimal impact on the body (e.g., bandages, medical gloves).
Class B (low to moderate risk): Devices with limited interaction or intervention (e.g., basic blood pressure monitors).
Class C (moderate to high risk): Devices used for important diagnostic or therapeutic purposes (e.g., ultrasound machines).
Class D (high risk): Devices that directly affect life-support or involve invasive use (e.g., ventilators, implantable devices).
Accurate classification is a crucial first step in the medical device registration process, as it determines the required regulatory pathway and documentation.
