China issues rules on recall of defective medical equipment
11-Feb-17, ECNS
China Food and Drug Administration (CFDA) has released rules on the recall of medical equipment.
Manufacturers must take responsibility for the safety of their equipment and are obliged to have a recall mechanism in place. They are also required to investigate and evaluate equipment and recall defective items.
%20Xinhua%20Finance%20Agency.jpg "China issues rules on recall of defective medical equipment (c) Xinhua Finance Agency")
Image: Xinhua Finance Agency
Three levels for recall accord with the seriousness of the defect, with the first class applied to equipment which poses a serious health risk. High-risk equipment will be placed under stricter control.
Businesses and users are asked to assist in investigation and evaluation by manufacturers and cooperate in cases of recall.