The implementation of medical device classification aims to differentiate medical devices based on their intended function, technical structure, and mode of action, allowing them to be included in different management requirements. This ensures the safety and effectiveness of medical device use while improving management efficiency. The "Medical Device Classification Rules" have played a positive role in guiding the development of the "Medical Device Classification Catalog" and determining new product registration categories.
1. Medical devices whose safety and effectiveness can be guaranteed by routine management. Examples include: bandages, skin preparation knives, stethoscopes, etc.
2. Medical devices whose safety and effectiveness must be controlled. Examples include: blood pressure monitors, thermometers, non-invasive medical sensors, etc.
3. Medical devices implanted in the human body to support/maintain life; those posing potential risks to the human body, whose safety and effectiveness must be strictly controlled. Examples include: indwelling intravenous catheters, disposable intravenous infusion needles, pacemakers, etc.
