Medical network May 2 - May 1, the state drug administration order - 29 "measures for the management of medical device recall" formally implemented, this will be the end of previous domestic machinery enterprises even if quality problems are also the state of the recall, instead must recall, otherwise will be punished by the law. 

 

The regulations clearly stipulate that the main body of the recall involves the registrant of domestic medical instruments and the designated agent in the territory of foreign medical instruments. This means that in the past we often see only foreign machinery enterprises publicly recalled products appear defects, and the CFDA phenomenon will also be published in the official website, the future will spread to all the domestic machinery enterprises, recall has become a compulsory measures. 

 

Since 2015, the drug safety system for medical device regulatory gradually turned to the production, circulation, use the whole process of double random inspection, and the increasingly frequent checking and daily inspection. Products stipulated by the local medical instrument sampling does not accord with a standard, find out in the CFDA fly inspection levels, has released this year 9 issue of the announcement of the quality, and do not conform to the standard stipulated in the provincial inspection even more. 

 

To be sure, as the flight inspection, sampling, the strengthening of routine inspections, 1.8 China medical device manufacturing enterprise, the quality problem, the possibility of quality defects are exposed will greatly increase. 

 

But until now, the domestic medical equipment company is rare in view of the "do not conform to the standard products" to recall, there are few of defect product recall. 

 

The author access since January 1, 2016 CFDA website published domestic medical device recall, only Shanghai medical kang dove medical equipment co., LTD., the rest are all foreign machinery companies or agents. In addition, there was a case in sichuan last November when a domestic medical device was ordered to be recalled. 

 

It is difficult to say that our more than 10,000 indigenous weapons companies produce quality products that are better than imported ones. The commission said no one would believe it. But why is it so hard to recall? 

 

Parker, vice secretary of China association of medical supplies by the blue equipment access to think, the reason is mainly the regulations also in drafting, reviewing, imperfect also caused; In the meantime, there have been limited penalties for those who refuse to recall weapons. 

 

What products will be recalled? 

 

And the regulations that are issued are described as a medical device that is defective and needs to be recalled. 

 

Products that may endanger the health and safety of human life under normal use; 

 

Products that do not conform to mandatory standards, registered or filed product technical requirements; 

 

Products that do not conform to the regulations concerning the production of medical devices and the management of quality management, which may cause unreasonable risks; 

 

Other products that need to be recalled. 

 

The main contents of the official assessment of medical devices are: 

 

(1) whether the product meets the compulsory standards, the requirements of the product technical requirements that are registered or filed; 

 

(2) whether any failure or injury occurred in the use of medical instruments; 

 

(3) used in the existing environment will cause harm, whether to have scientific literature, research, relevant tests or validation can explain the cause of the injuries; 

 

(4) the area and the characteristics of the people involved in the injury; 

 

(5) the degree of injury to human health; 

 

(6) the probability of injury occurring; 

 

(7) the short-term and long-term consequences of the injury; 

 

(8) other factors that may cause injury to the human body. 

 

The recall will be officially announced 

 

According to the severity of the medical device defect, medical device recall is divided into: 

 

(1) primary recall: using this medical instrument may or may have caused serious health hazards; 

 

(2) secondary recall: using the medical instrument may or may have caused temporary or reversible health hazards; 

 

(3) tertiary recall: the possibility of using the medical device to cause harm is small but still needs to be recalled. 

 

Medical device manufacturing enterprise shall be determined according to the specific situation and according to the level of recall recall level and sales of medical equipment and usage, scientific design recall plan and organize their implementation. 

 

In the case of a first class recall, the notice of the medical device recall shall be published on the website of the state administration of food and drug administration and the main media of the central government; 

 

In case of a secondary or tertiary recall, the notice of medical device recall shall be published on the website of the food and drug administration department of the province, autonomous region and municipality directly under the central government. 

 

Medical device manufacturing enterprise of medical device recall decision making, higher recall should in 1 days, secondary recall should be within 3 days, three levels of recall shall, within 7 days, inform the relevant medical equipment management enterprise, use the unit or inform the user. 

 

If a recall is ordered 

 

The food and drug supervision and administration department after a survey to assess that medical device production enterprise shall recall defective medical devices and not voluntary recall, medical device manufacturing enterprise shall be ordered to recall medical apparatus and instruments. 

 

When necessary, the food and drug supervision and administration department may require medical equipment producing enterprises, trading enterprises and use the unit immediately suspend the production, sale and use, and inform the user immediately suspend the use of the defective product. 

 

In the case of legal liability, the law stipulates that medical device manufacturers shall not be exempted from other legal liabilities that they shall bear in accordance with the law.