In order to further strengthen the supervision and management of medical equipment business processes, state food and drug supervision bureau will arrange in October 2016, in view of the medical equipment management enterprise flight check.
According to the pharmaceutical medical instrument flight check method ", the state drug safety administration is responsible for organizing the implementation of the nationwide flight check, check within the jurisdiction of the local food and drug administration is responsible for this flight. So the CFDA expansion will be a national machinery comac action.
For the fly how will check the specific implementation, there is no disclosure for more details. However, you can speculate.
From the time point of view, the flying test action will closely related with machinery business illegal conduct regulation.
Circulation of the administration about the regulation of medical equipment management behavior in the field of public announcement no. 112 (2016) "(hereinafter referred to as" the announcement no. 112) : 2016 July 15 is machinery dealer active comprehensive improvement, and submit the report on time. Provincial food and drug administration shall be responsible for the supervision and inspection on September 30, the summary submitted to the state administration and regulation.
Administration of forefoot received provincial regulation, hind feet start the flight check, if has nothing to do both, possibility is too small.
The focus of the inspection object, so machinery daqo regulation should also be the focus of the inspection object.
According to the announcement no. 112 ", three types of enterprises is to supervise and inspect the object as the key: one is the low level of daily management, marketing channel chaotic, multiple problems such as more case, poor and less inspection found that the problem and corrective actions of enterprises; 2 it is in a low temperature, cold storage medical equipment management enterprise; Third, the agent of imported medical equipment in. The flight check, these three companies are likely to need to be careful.
As for the inspection content, in addition to the announcement no. 112, included in the eight illegal conduct, perhaps more important is the medical equipment management and the quality control standard for the implementation of the situation. The "specification" and "medical equipment production and the quality control standard", is in December 2014 announcement, while the latter is the CFDA began in March for fly to check the most important content of medical device manufacturing enterprise.
Anyway, after flight check YiXie production enterprises, YiXie enterprise flight check should also be in the years to come, medical equipment industry in the production and operation of the compliance of unprecedented importance.
After being drug safety flying inspection?
On the basis of the pharmaceutical medical instrument flight check method ", the agency according to test results, can be in accordance with the law to make correction, warning signals, questioning the units under inspection and supervision of recalled products, withdraw or cancel the qualification certificate of accreditation, and suspended development, production, sales, use risk control measures.
CFDA to organize and implement the inspection found the illegal behavior to initiate an investigation, the CFDA can investigate and punish directly, you can also specify the agency inspected unit seat is investigated.
Refuses or escapes detection, serious consequences!
Also on the basis of the pharmaceutical medical instrument flight check method ", the agency shall have the right at any time into the relevant premises for inspection of the units inspected. If the units being inspected refuses or escapes check, inspection group is to written records, and shall be ordered to correct; After rectification is not correct, unable to complete the inspection work, check the conclusion will be directly judged to be not conform to the relevant quality management specification or other related requirements.
Five kinds of situations would be considered refuses or escapes check:
1, delay, limit, refused to admit inspectors check place or area, or limit inspection time;
2, without good reason not to provide or delay, and check the relevant documents, records, bills, vouchers, electronic data and other materials;
3, with claims that the staff is not, and deliberately to stop the production and business operation methods such as cheating, misleading, escape inspection;
4, rejection, or limit filming, photocopying, forensics work such as sampling;
5, other do not cooperate with check.
In addition, the units under inspection if any of the following circumstances, constitute ACTS violating the administration of public security, the agency can also, please make administrative penalties for public security by public security organs:
1, hinder the inspectors from fulfilling their duties pursuant to law, or personal safety threat inspectors;
2, forge, alter, buy and sell or use forged or altered certificate of approval documents, certification, etc;
3, hiding, transferring, selling or break down the food and drug supervision and administration department in accordance with the law of property seizure, detainment;
4, forge, hide or destroy evidence or providing false testimony, to carry out the inspection in accordance with the law. |
