Article(id=1320389052285702757, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388809389355957, articleNumber=null, orderNo=null, doi=10.11876/mimt202501006, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1792734881706, onlineDateStr=2026-10-23, pubDate=1739116800000, pubDateStr=2025-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792734881706, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792734881706, creator=13701087609, updateTime=1792734881706, updator=13701087609, issue=Issue{id=1320388809389355957, tenantId=1146029695717560320, journalId=1319373289681944729, year='2025', volume='31', issue='1', pageStart='1', pageEnd='104', issueExtLink='null', onlineDate='null', pubDate='1739116800000', pubDateStr='2025-02-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792734823796, creator='13701087609', updateTime=1792746481175, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437704052027415, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388809389355957, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437704056221720, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388809389355957, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=32, endPage=36, ext={EN=ArticleExt(id=1320389052453474918, articleId=1320389052285702757, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=Analysis and comparisons for differences with registration submission dossiers for medical devices in China, European Union and Canada, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=

This article introduces and discusses on analysis of the differences for Registration Submission Dossiers for Medical Devices (excluding innovation products) in China、European Union and Canada, Analysis and comparison of differences in Registration Submission Dossiers. Through comparison and analysis of differences, although the focus of medical device registration processes varies in different countries, but according to its medical device management system, submitting Registration Submission Dossiers strictly per relevant requirements which ensure the safety and effectiveness of the marketed products.

, authors=Chaonan Wang¹, Qiang Fu^{2, *}, authorsList=Chaonan Wang, Qiang Fu, authorCompany=null, correspAuthors=Qiang Fu, authorNote=null, correspAuthorsNote=null, copyrightStatement=All copyrights in 2025 belong to the sponsor of the journal.Not content published by the journal may be reproduced or abridged without authorization., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1320389052797407847, articleId=1320389052285702757, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=中国、欧盟和加拿大医疗器械注册申报资料差异对比及分析, columnId=1320381056239387017, journalTitle=现代仪器与医疗, columnName=医学工程, runingTitle=null, highlight=null, articleAbstract=

本文针对中国、欧盟和加拿大医疗器械（除创新产品外）注册申报资料要求的差异进行比较和研究。经差异对比及分析，虽然各国医疗器械注册流程侧重点不同，但根据其医疗器械管理制度，严格按要求递交注册申报资料都能保证上市产品的安全性和有效性。

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王超楠，女，硕士研究生，研究方向：医疗器械注册质量

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王超楠，女，硕士研究生，研究方向：医疗器械注册质量

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