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譯文摘錄（保密內容以XXX代替）：
 
上海市食品藥品監(jiān)督管理局關于進一步加強醫(yī)療器械經營企業(yè)監(jiān)督管理的通知
Notice of Shanghai Food and Drug Administration on Strengthening Supervision and Management of Medical Device Businesses
 
各區(qū)市場監(jiān)督管理局：
Market supervision & management bureaus of each district:
 
  近年來，隨著醫(yī)療器械監(jiān)管法規(guī)修訂完善和監(jiān)管工作的不斷深入，我市醫(yī)療器械經營企業(yè)的法律法規(guī)意識不斷提高。但我局在日常督查、舉報投訴、案件查辦以及相關工作調研中發(fā)現(xiàn)，部分醫(yī)療器械經營企業(yè)仍存在質量管理的薄弱環(huán)節(jié)，個別企業(yè)違法違規(guī)行為依然時有發(fā)生。為進一步加強我市醫(yī)療器械經營環(huán)節(jié)的監(jiān)管，現(xiàn)將有關事項通知如下：
  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、進一步加強醫(yī)療器械經營企業(yè)全程監(jiān)管
  I. Further strengthening whole-process supervision of medical device businesses
  按照“誰審批、誰負責”的原則，區(qū)市場監(jiān)管局應當在加強醫(yī)療器械經營企業(yè)許可準入的同時，進一步加強事中事后監(jiān)管，嚴格落實屬地監(jiān)管責任，加強對轄區(qū)器械經營企業(yè)的法規(guī)宣傳培訓，強化企業(yè)法律法規(guī)意識，落實企業(yè)主體責任。對經營場地和庫房分設兩個轄區(qū)的經營企業(yè)要加強日常監(jiān)管，認真核查企業(yè)實際經營和儲存配送情況。對于申請主動注銷經營資質的企業(yè)，應核實是否被立案調查尚未結案及產品處置情況，防范安全風險。對于企業(yè)擅自變更經營場所和庫房，以及未按照法規(guī)及醫(yī)療器械經營質量管理規(guī)范開展經營的行為應當嚴厲查處。
  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.