The Food and Drug Administration has issued the "Measures for the Management of Medical Device Recalls" (hereinafter referred to as the "Measures"), which clearly stipulates that it is necessary to strengthen the risk of controlling medical device products that are defective after listing, eliminate potential safety hazards of equipment, implement the responsibility of corporate recall, and protect public safety. The "Measures" will be officially implemented on May 1.
As a special commodity, medical devices play an important and irreplaceable role in improving people's health and improving people's quality of life. The safety and effectiveness of medical devices is directly related to the health of the people and the harmony and stability of the society. It is a major issue of people's livelihood and public safety. If the listed products are defective and cannot be recalled and controlled in time, they may endanger the health and safety of consumers. Therefore, the establishment and implementation of a medical device recall system by the state plays an important role in controlling the risks of medical device products that are defective after listing, eliminating potential safety hazards and protecting public safety.
The "Measures" require that medical device operating enterprises and users should actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with production enterprises to fulfill their recall obligations, and timely convey and feedback medical device recall information in accordance with the recall plan, control and recovery. Defective product.
According to the Measures, according to the different starting conditions of medical device recalls, medical device recalls are divided into active recalls and ordered recalls. Voluntary recall is a legal obligation of a medical device manufacturer to conduct quality assessment of medical device products produced according to relevant requirements or according to product adverse events and to determine defects in medical device products. The order was recalled by the food and drug supervision department after investigation and evaluation. It is believed that the medical device manufacturer should recall the defective medical device products and did not take the initiative to recall it, and ordered the medical device manufacturer to implement the medical device recall. In practice, the company should take the initiative to recall the initiative, and the government department should order the recall as a supplement.
Depending on the severity of the medical device defect, the recall of the medical device is divided into three levels: the use of the medical device may or may have caused a serious health hazard for a first-level recall; the use of the medical device may or may have caused a temporary or reversible health hazard. For a secondary recall; the use of the medical device is less likely to cause harm but a recall is still required for a three-level recall.
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