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.
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.
Manufacturers should notify businesses and users of recall decisions within one day.
Businesses and users are asked to assist in investigation and evaluation by manufacturers and cooperate in cases of recall.
In practice, most recalls should be issued by the manufacturers, though the government will also have that power, according to the CFDA. The rules mandate food and drug authorities to order a recall if the manufacturers fail to do so.
The system was first put forward in a regulation in 2014, in addition to a monitoring system for adverse events caused by medical equipment and a reappraisal mechanism for registered equipment.
China first introduced the regulation on the supervision of medical equipment in 2000.
