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譯文摘錄（保密內(nèi)容以XXX代替）：
 
上海市食品藥品監(jiān)督管理局關(guān)于進(jìn)一步加強(qiáng)醫(yī)療器械經(jīng)營(yíng)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(chǎng)監(jiān)督管理局：
Market supervision & management bureaus of each district:
 
  近年來(lái)，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(jīng)營(yíng)企業(yè)的法律法規(guī)意識(shí)不斷提高。但我局在日常督查、舉報(bào)投訴、案件查辦以及相關(guān)工作調(diào)研中發(fā)現(xiàn)，部分醫(yī)療器械經(jīng)營(yíng)企業(yè)仍存在質(zhì)量管理的薄弱環(huán)節(jié)，個(gè)別企業(yè)違法違規(guī)行為依然時(shí)有發(fā)生。為進(jìn)一步加強(qiáng)我市醫(yī)療器械經(jīng)營(yíng)環(huán)節(jié)的監(jiān)管，現(xiàn)將有關(guān)事項(xiàng)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(jìn)一步加強(qiáng)醫(yī)療器械經(jīng)營(yíng)企業(yè)全程監(jiān)管
  I. Further strengthening whole-process supervision of medical device businesses
  按照“誰(shuí)審批、誰(shuí)負(fù)責(zé)”的原則，區(qū)市場(chǎng)監(jiān)管局應(yīng)當(dāng)在加強(qiáng)醫(yī)療器械經(jīng)營(yíng)企業(yè)許可準(zhǔn)入的同時(shí)，進(jìn)一步加強(qiáng)事中事后監(jiān)管，嚴(yán)格落實(shí)屬地監(jiān)管責(zé)任，加強(qiáng)對(duì)轄區(qū)器械經(jīng)營(yíng)企業(yè)的法規(guī)宣傳培訓(xùn)，強(qiáng)化企業(yè)法律法規(guī)意識(shí)，落實(shí)企業(yè)主體責(zé)任。對(duì)經(jīng)營(yíng)場(chǎng)地和庫(kù)房分設(shè)兩個(gè)轄區(qū)的經(jīng)營(yíng)企業(yè)要加強(qiáng)日常監(jiān)管，認(rèn)真核查企業(yè)實(shí)際經(jīng)營(yíng)和儲(chǔ)存配送情況。對(duì)于申請(qǐng)主動(dòng)注銷經(jīng)營(yíng)資質(zhì)的企業(yè)，應(yīng)核實(shí)是否被立案調(diào)查尚未結(jié)案及產(chǎn)品處置情況，防范安全風(fēng)險(xiǎn)。對(duì)于企業(yè)擅自變更經(jīng)營(yíng)場(chǎng)所和庫(kù)房，以及未按照法規(guī)及醫(yī)療器械經(jīng)營(yíng)質(zhì)量管理規(guī)范開(kāi)展經(jīng)營(yíng)的行為應(yīng)當(dāng)嚴(yán)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.