Medical network on December 22, recently, the anhui province food food and drug administration at the provincial 25 class iii medical device manufacturing enterprise collective interview will mark the anhui era officially the most strict supervision of medical equipment. Conference, reported since 2016, the province class iii medical device manufacturing enterprise to perform "specification" of the check-up report data, 25 companies a total of 278 defects were found to projects.
The meeting is the first time for anhui province food drug administration medical device manufacturing enterprise for questioning, the purpose is to urge the third class medical device manufacturing enterprise full implementation of the medical device production quality management norms "(hereinafter referred to as the" specification ").
Questioning, the anhui province bureau reported since 2016, the province's third class medical device manufacturing enterprise implement "specification" of the check-up report data, 25 companies a total of 278 defects were found to projects (critical defects in 65, 213 general defects), involved in 52 "institutions and personnel", "workshop and facilities" 47 items and 31 "equipment", "document management" 24, "design" 16, 21 "procurement", 42 "production management", 32 "quality control", the "other" 13. Among them, the ring anhui Beijing medical supplies co., LTD., due to the quality management system of major defects "shot", by the food drug administration put on record for investigation of chuzhou, other 24 companies were ordered to make correction.
Inspection found that the quality management consciousness, lack of key positions and insufficient business ability is the most common problems of the enterprise. For example, some enterprises in implementing the regulations to the form without the god, documents and the actual operation "two skin"; Some enterprises at the time of registration using pure "takes doctrine", by not familiar with their living; Some enterprises in the business training can't adapt to the medical instrument under the new situation, policies and regulations introduced intensive apprehend the opaque relevant personnel of law spirit, to the new specifications are not familiar with, do not understand the relevant regulatory policies, difficult to be carried out in accordance with the "standard" requirement of strict production management and quality control, etc.
According to the national food administration of drug safety, all third class medical device manufacturing enterprise since January 1, 2016 must be in conformity with the specification requirements. To this, the provincial food drug administration without, earlier this year issued in a timely manner on the supervision and the opinions of the medical equipment production and the quality control standard for the implementation of the law, to take training, check list and check the "three steps" strategy, carrying out medical device regulatory policies and regulations of the enterprise stable cross, on the basis of the enterprises themselves to find problems and rectification, and drug regulators "into three feet", defects of key mining enterprises deeply, from the perspective of overall and local "two-dimensional" summary to analyze the causes of the problem, and make a subsequent supervision of key links and key projects, for scientific and effectively promote the implementation of the "specification" laid a solid foundation.
Food drug administration in anhui province is introduced, all of the medical device manufacturing enterprise must set up the good faith consciousness, strengthening industry self-discipline, strictly implement enterprise's main body responsibility, earnestly fulfill the requirement of regulations and policies of the medical apparatus and instruments, this "bottom line" of medical equipment is safe and effective. Otherwise light was ordered to rectification, or severely punished by regulatory authorities, the end is not an under strict regulation, is in strives for the survival by the quality of the cruel market competition is on the way out. |
