翻译热线:(86 10) 5979 9298

biz@practrans.cn

2017-10-28 品格翻译继续为某美资医疗器械公司提供高级翻译(Policy Translation),翻译方向:中译英。翻译内容:食品药品监督管理局通知。

2018-07-03 10:16:19 2

译文摘录(保密内容以XXX代替):

 

上海市食品药品监督管理局关于进一步加强医疗器械经营企业监督管理的通知

Notice of Shanghai Food and Drug Administration on Strengthening Supervision and Management of Medical Device Businesses

 

各区市场监督管理局:

Market supervision & management bureaus of each district:

 

近年来,随着医疗器械监管法规修订完善和监管工作的不断深入,我市医疗器械经营企业的法律法规意识不断提高。但我局在日常督查、举报投诉、案件查办以及相关工作调研中发现,部分医疗器械经营企业仍存在质量管理的薄弱环节,个别企业违法违规行为依然时有发生。为进一步加强我市医疗器械经营环节的监管,现将有关事项通知如下:

In recent years, as the laws on the supervision of medical devices have been revised and improved gradually, and the regulation has also been strengthened, the medical device businesses in Shanghai have also constantly improved their legal consciousness. But our administration has found in daily supervision, reported complaints, case investigation and relevant survey that some medical device businesses still lack effective quality management and some businesses even have violation acts. In order to strengthen the supervision of business operation of medical devices in Shanghai, relevant measures are hereby notified as follows:

  一、进一步加强医疗器械经营企业全程监管

I. Further strengthening whole-process supervision of medical device businesses

按照“谁审批、谁负责”的原则,区市场监管局应当在加强医疗器械经营企业许可准入的同时,进一步加强事中事后监管,严格落实属地监管责任,加强对辖区器械经营企业的法规宣传培训,强化企业法律法规意识,落实企业主体责任。对经营场地和库房分设两个辖区的经营企业要加强日常监管,认真核查企业实际经营和储存配送情况。对于申请主动注销经营资质的企业,应核实是否被立案调查尚未结案及产品处置情况,防范安全风险。对于企业擅自变更经营场所和库房,以及未按照法规及医疗器械经营质量管理规范开展经营的行为应当严厉查处。

The principle that “those granting approvals shall be held accountable” shall be adopted. The market supervision bureaus of each district shall intensify regulation during and after the event while tightening the permitted access of medical device businesses, so that each administrative district will perform their due responsibilities. At the same time, laws and regulations shall be publicized and promoted among local medical device businesses, to strengthen their legal awareness and urge them to fulfill their responsibilities as business entities. As for the business operators whose operation site and storage site are set in different administrative districts, daily regulation shall be strengthened, to carefully verify the practical operation, storage and delivery of these businesses. The enterprises that initiatively deregister the business qualification shall be verified to check whether they are under investigation, whether the investigation is still underway, and the progress of product disposal, to prevent safety risks. Enterprises shall be investigated and punished strictly if they change their operation sites and storages without authorization, and engage in operations that are not in compliance with laws or with the operation and quality management standards for medical devices.