Article(id=1242138761472062388, tenantId=1146029695717560320, journalId=1146031591421210625, issueId=1242138750193578878, articleNumber=null, orderNo=11, doi=10.3981/j.issn.1000-7857.2020.22.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1585324800000, receivedDateStr=2020-03-28, revisedDate=1601308800000, revisedDateStr=2020-09-29, acceptedDate=null, acceptedDateStr=null, onlineDate=1610588808873, onlineDateStr=2021-01-14, pubDate=1606492800000, pubDateStr=2020-11-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1610588808873, onlineIssueDateStr=2021-01-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1774078558553, creator=sys-migrate, updateTime=1774078558553, updator=sys-migrate, issue=Issue{id=1242138750193578878, tenantId=1146029695717560320, journalId=1146031591421210625, year='2020', volume='38', issue='22', pageStart='1', pageEnd='148', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=3, issueType=-1, specialIssue=null, createTime=1774078555865, creator=sys-migrate, updateTime=1774078555865, updator=sys-migrate, preIssue=null, nextIssue=null, ext=null, issueFiles=null}, startPage=25, endPage=30, ext={EN=ArticleExt(id=1242138764781363803, articleId=1242138761472062388, tenantId=1146029695717560320, journalId=1146031591421210625, language=EN, title=Reform proposal for China's medical device registration inspection system, columnId=1242136657818890846, journalTitle=Science & Technology Review, columnName=Think Tank, runingTitle=null, highlight=null, articleAbstract=The registration inspection is a compulsory inspection procedure for Class II and Class III medical device products before registration and marketing. The development of China's medical device inspection service market is relatively backward, and the development of third-party inspection agencies is slow. At present, the registration and the inspection of medical devices are mainly completed by official medical device inspection institutions, with the responsibilities of the government and the enterprises being mingled, and the industry inspection demand is difficult to meet. For clarifying the relationship between the regulatory authorities and the industry enterprises, it is suggested that the current medical device registration and inspection system should be reformed by using the self inspection, the entrusted inspection and the role transformation of inspection institutions., correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=1JaQLruPU8sZ4s81pp49Jw==, pdfFileSize=469557, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=1. Shanghai University of Medicine & Health Sciences, Shanghai, 201318, China;
2. Shanghai University of Finance and Economics, Shanghai 200433, China, fund=null, authors=JIANG Haihong^1,2, ZHANG Jie¹, ZHANG Peiming¹, authorsList=JIANG Haihong, ZHANG Jie, ZHANG Peiming), CN=ArticleExt(id=1242138763611157448, articleId=1242138761472062388, tenantId=1146029695717560320, journalId=1146031591421210625, language=CN, title=革新中国医疗器械注册检验制度的建议, columnId=1242136656816448100, journalTitle=科技导报, columnName=智库观点, runingTitle=null, highlight=null, articleAbstract=注册检验是第二类和第三类医疗器械产品注册上市前的强制性检验程序，中国医疗器械检验服务市场发展较落后，第三方检验机构发展缓慢。针对当前医疗器械注册检验主要由官方医疗器械检验机构完成，导致政企主体责任不分、行业检验需求难以满足的问题，建议在厘清监管部门和行业企业的关系基础上，从自我检验、委托检验、检验机构角色转型等途径来革新现行医疗器械注册检验制度。, correspAuthors=null, authorNote=蒋海洪,副教授,研究方向为药品医疗器械法规与政策,电子信箱:jianghh168@hotmail.com, correspAuthorsNote=张培茗(通信作者),副教授,研究方向为医疗器械检测技术与安全评价,电子信箱:zpmking@163.com, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=KSyvBLhU4nAdmKhW3oUbzQ==, pdfFileSize=469557, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=1. 上海健康医学院医疗器械学院, 上海 201318;
2. 上海财经大学法学院, 上海 200433, fund=中国药品监督管理研究会项目（CSDR-QXJG-2019-0005）, authors=蒋海洪^1,2, 张杰¹, 张培茗¹, authorsList=蒋海洪, 张杰, 张培茗)}, authors=[Author(id=1277349054556279314, tenantId=1146029695717560320, journalId=null, articleId=1242138761472062388, orderNo=null, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=null, email=null, emailSecond=null, emailThird=null, correspondingAuthor=null, authorType=null, ext={}, companyList=null)], keywords=[Keyword(id=1242138763225277000, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242138761472062388, language=CN, orderNo=1, keyword=医疗器械), Keyword(id=1242138763304968778, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242138761472062388, language=CN, orderNo=1, keyword=注册检验), Keyword(id=1242138763376271947, tenantId=1146029695717560320, journalId=1146031591421210625, articleId=1242138761472062388, language=CN, orderNo=1, keyword=检验机构), 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