昨日，北京市药监局通报称，拟对非法生产义齿(假牙)的北京精佳艺义齿中心从重处罚，吊销其《医疗器械生产企业许可证》，将该企业相关责任人员列入“黑名单”，并禁止其再进入医疗器械制售行业。

yesterday,Beijing says the administration's report,Quasi of illegal production denture(dentures)Beijing refined beautiful art denture center shall be given heavier punishment,Shall revoke its[Medical device manufacturing enterprise license],Will this enterprise the related liable persons in"blacklist",And prohibited from its again into the medical equipment manufacturing industry.

　　这或将是国家药监局药械“黑名单”新政今年10月1日实施后，北京市首起列入监管“黑名单”的药械生产企业。

This will be the country's drug watchdog YaoXie or"blacklist"The New Deal October 1 after implementation,Beijing first up in supervision"blacklist"The YaoXie production enterprise.

精佳艺义齿中心或将被“吊证”重罚 With a good art denture center or will be"Hanging card"Carried out

　　11月26日(本周一)，新京报记者调查报道了北京精佳艺义齿中心，在未取得医疗器械注册证的情况下，生产劣质假牙，再售给北京一些民营医院和北京周边地区的医院，谋取非法利润。

November 26(On Monday),The Beijing news reporter survey said the Beijing fine beautiful art denture center,Without obtaining a medical instrument registration in the circumstances,Production inferior dentures,Then sold to Beijing some civilian battalion hospital and Beijing surrounding area hospital,Seek illegal profit.

　　11月25日，市药监局派出执法人员，根据记者举报线索，对北京精佳艺义齿中心进行突击检查。

November 25th,The city's drug watchdog sent law enforcement personnel,According to press reports clues,For Beijing fine beautiful art denture center assault inspection.

　　昨日，市药监局副局长、新闻发言人袁林介绍，经立案调查，北京精佳艺义齿加工中心具备《医疗器械生产企业许可证》，但其在申报医疗器械义齿注册证尚未获得批准的情况下，擅自生产和对外经营，属于违法行为，且明知故犯，情节恶劣。目前，该企业生产现场已被查封。

yesterday,The city administration's vice director/News spokesman YuanLin is introduced,The initiate an investigation,Beijing refined beautiful art denture with machining center[Medical device manufacturing enterprise license],But the declaration medical instrument denture registration certificate has not yet won approval,Do STH without authorization production and foreign business,Belong to illegal behavior,And knowingly violate,Plot bad.At present,This enterprise production field has been attachment.

　　医疗器械关乎患者健康甚至生命。袁林说，任何违法违规行为，无论情节严重与否，北京市药监局均一律从严查办。针对此次案件，袁林说，市药监局拟吊销北京精佳艺义齿中心的《医疗器械生产企业许可证》，不再批准其义齿产品，将该企业相关责任人员列入北京药械监管“黑名单”，向社会公示，并实行(医疗器械)行业“禁入”制。

Medical equipment for patients health even life.YuanLin said,Any illegal behavior,No matter if the circumstances are serious or not,Beijing's drug watchdog are all strict investigation.According to the case,YuanLin said,The city's drug watchdog quasi shall revoke the Beijing fine beautiful art denture center[Medical device manufacturing enterprise license],No longer approval the denture products,Will this enterprise the related liable persons in Beijing YaoXie supervision"blacklist",To social public,And implement(Medical devices)industry"stands"system.

购用非法义齿医院继续严查曝光 Purchase and use illegal denture hospital continue to attracted exposure

　　袁林介绍，经初步查证，精佳艺义齿中心非法生产的义齿主要销往外埠(如河北、内蒙古等北京周边地区)，以及北京市恒安中医院、华仁医院两家民营医院。目前，市药监局已对恒安中医院、华仁医院进行立案调查，对其向患者销售、安装非法义齿的行为，没收违法所得，并进行高限处罚。

YuanLin introduced,After the preliminary verification,With a good art denture center illegal production denture are mainly sold to outgoing(Such as hebei/Inner Mongolia Beijing surrounding areas),And Beijing heng an hospital of traditional Chinese medicine/HuaRen hospital two civilian battalion hospital.At present,The city's drug watchdog has to heng an hospital of traditional Chinese medicine/HuaRen hospital to initiate an investigation,The sales to patients/Install the behavior of illegal denture,Confiscated of the illegal income,And high limit punishment.

　　精佳艺非法义齿在北京的销售范围究竟有多大？袁林表示，调查还在进行中。一旦发现涉及采购该企业违法产品的其他医疗机构，北京市药监局必将核实一家查处一家，查处一家曝光一家。

With a good art illegal denture in Beijing sales range exactly how much?YuanLin said,The survey also in the process.Once found involved in purchasing this enterprise the illegal product other medical institutions,Beijing's drug watchdog will verify a investigate a,Investigate a exposure a.

　　同时，北京市药监局承诺，将联合市卫生局，对全市义齿生产企业和口腔诊所进行摸查，发现非法制售义齿行为，将一律依法从重处罚。

At the same time,Beijing, the administration's commitment,The municipal bureau of health, will jointly,For the denture manufacturing enterprises and oral MoZha clinic,Find illegal manufacturing denture behavior,Will all shall be given heavier punishment according to law.

焦点1 已售义齿尚无召回方法 Focus 1 already sold denture is no recall method

　　市药监局医疗器械处处长任达志：目前看，尚没有有效可行的召回方法。2011年，国家药监局颁布并试行《医疗器械召回管理办法》，对缺陷医疗器械探索三级召回制。坦诚说，医疗器械品目繁多，而义齿虽从2000年起，纳入医疗器械管理，但属于定制型的医疗器械。这种需要嵌入人体，达到一定治疗效果的医疗器械，如何召回，还需在我们的医疗器械安全监管执法实践中，进一步探索。

The city's drug watchdog medical instrument marshal RenDa volunteers:Now look at,There are no effective feasible recall method.In 2011,,The administration's country promulgated and trial implementation[The measures for the administration of the medical equipment recall],Defects on medical equipment exploration level 3 recall system.Frank said,Medical equipment various items,And though denture since 2000,Into the medical equipment management,But belongs to custom type of medical apparatus and instruments.This need to embed the human body,To a certain therapeutic effect of medical devices,How to recall,Still need in our medical equipment safety supervision law enforcement practice,Further explore.

焦点2 受害患者可申请赔偿 Focus 2 patients with victims may apply for compensation

　　市药监局副局长新闻发言人袁林：受害患者可通过司法途径，起诉非法义齿的制售厂商或医疗机构，申请民事赔偿。

The city administration's vice director YuanLin spokesman:The patient may suffer through judicial way,Sue illegal denture manufacturing of manufacturers or medical institutions,Apply for civil compensation.

　　药监局目前将对非法义齿“一追到底”，肃清产品的销售、使用路径。

At present, the administration's to illegal denture"A after the",Clear product sales/Use path.

　　另外，近期将通过市药监局官方网站等媒介，公示北京市70余家正规的义齿生产企业，希望医疗机构和患者，在购进、使用义齿时，先查查产品信息，更好维护自己的权益。(记者魏铭言)

In addition,In the near future will through the city administration's web site and media,Public Beijing more than 70 normal denture production enterprise,Hope that medical institutions and patients,In the purchase/Use the denture,To check the product information,Better protect their own rights and interests.(Reporter MingYan wei)