全省医疗器械“五整治”有关情况发布会

　　[2014.08.26] Report of the news conference

　　Translated by Fang Yuanyuan

　　[10:00:00 August 26 , 2014]Chen Qiang: ladies and gentlemen,good morning. Welcome to the press conference. According to the national food and medicine administration of the unified deployment, Shandong food and drug administration launches the provincial area of the activity,especially five kinds of illegal use of unlicensed products,they are regulation of medical devices registered a false declaration, illegal production, illegal business and hype.

　　[10:01:10 August 26 , 2014]Sun Yuting:Combining our province, custom denture included "Five remediation" range,they were focused remediation. Care and support closely cooperate with public security, health and Planning Commission, the industrial and commercial sectors and the media under this action by the provincial food and drug regulatory system organizations have achieved remarkable results, for investigation of a number of typical cases, effectively punished illegal acts. The province of medical equipment production and business conduct further standardize the market order further improved. Here, on behalf of the Provincial Food and Drug Administration, I inform you about the situation of the special action.

　　[10:04:22 August 26 , 2014]Sun Yuting: the basis situation. First, the general situation of the five managements of the activity. The provincial food and drug management department pays much attention on the society and the citizens’ opinions of the medical instruments and the hard problem. To key products, key enterprises, key clues for a breakthrough, adhere to the investigation, remediation, standardized combination of severely punish illegal behavior,we make great efforts to eliminate the use of medical equipment production and business security risks exist, reaching a regulation for a class of product specifications the purpose of such acts.

　　[10:05:52 August 26 , 2014]Sun Yuting: second, the custom denture special rectification. To crack down on illegal acts custom denture production, we use links and standardize the market order to protect public health. According to the news media reflect the clues, the Bureau carried out for a period of one and a half months of custom denture rectification from March 15 to April 30.We further enhanced the level of safety of such products, and achieved good regulation effect.

　　[10:06:22 August 26 , 2014]Sun Yuting: third, the injection of sodium hyaluronate supervision and inspection. According to the national food and drug administration’s unique requirements, we launch the inspection work from May 4 to 20. After the investigation, medical institutions are using products factory direct purchasing channels basically dominated and we found no illegal business with the use of sodium hyaluronate injection undocumented behavior.

　　[10:08:00 August 26 , 2014]Sun Yuting: forth, the situation of the illegal inspections. Food and drug supervision departments at all levels are in accordance with the "four unities" requirements, adhere to strike out, Severe Punishment, strengthen coordination linkage with the public security departments for investigation of Yantai City.The denture unregistered wait for a custom denture case batch violations of laws on criminals a strong deterrent.

　　[10:08:00 August 26 , 2014]Sun Yuting:second, the basic arrangements. First, the elaborate organization and precise planning. The second is the bound propaganda to make the atmosphere. The third is with different measures to make it effective. The forth is to enhance the inspection to promote steadily. The fifth is to manage with