What’s The Registration Unit Rule Under Chinese Regulation For Ventilators?

A ventilator is a pulmonary ventilation device used to automatically increase or provide ventilation to a patient’s lungs. According to the Guidelines for the Classification of Registration Units of Medical Devices, active medical devices with different technical principles should be classified into different registration units.

According to the state of the art, critical-care ventilators, home-care ventilators, ventilators for first aid and transport, high frequency jet ventilators and high frequency oscillation ventilators with different technical principles should be classified as different registration units. Critical-care ventilators with different technical principles, such as electronically controlled pneumatic ventilators and electrically powered ventilators, should be classified as different registration units.

Ventilators with same technical principles but different product design structures (such as ventilators with different gas circuit designs) should be classified as different registration units. Passive consumables (such as breathing tube, tracheal cannula, mask, etc.) used in combination with the ventilator should be classified as different registration units.