Article(id=1320388830746755925, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388792901554957, articleNumber=null, orderNo=null, doi=10.11876/mimt202506014, 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=1792734828887, onlineDateStr=2026-10-23, pubDate=1765296000000, pubDateStr=2025-12-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792734828887, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792734828887, creator=13701087609, updateTime=1792734828887, updator=13701087609, issue=Issue{id=1320388792901554957, tenantId=1146029695717560320, journalId=1319373289681944729, year='2025', volume='31', issue='6', pageStart='1', pageEnd='96', issueExtLink='null', onlineDate='null', pubDate='1765296000000', pubDateStr='2025-12-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792734819865, creator='13701087609', updateTime=1792746371372, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320437243483902178, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388792901554957, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320437243483902179, tenantId=1146029695717560320, journalId=1319373289681944729, issueId=1320388792901554957, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=82, endPage=86, ext={EN=ArticleExt(id=1320388830906139478, articleId=1320388830746755925, tenantId=1146029695717560320, journalId=1319373289681944729, language=EN, title=Analysis of common problems on registration quality management system verification of customized denture manufacturers and technical review suggestions, columnId=null, journalTitle=Modern Instruments & Medical Treatment, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective

Focusing on the common problems in the registration quality management system verification of customized denture manufacturers, conducting cause analysis, and proposing technical review suggestions for customized denture products.

Methods

Collect and organize the on-site verification data of the registered quality management system of customized denture manufacturers in Guangdong Province in 2024, and analyze the non-conforming items and common problems identified during the on-site verification.

Results

In 2024, nearly 55 on-site verifications of the registered quality management system of customized denture manufacturers were conducted in the Guangdong Province, and a total of 243 non-conforming items were found. The non-conforming items were statistically sorted out, and the common problems found were specifically analyzed from seven aspects: organization and personnel, factory buildings, facilities and equipment, document management, design and development, procurement, production, and quality control, and technical review suggestions for customized denture products were put forward.

Conclusion

This article summarizes the on-site verification of the registration quality management system of customized denture manufacturers in Guangdong Province in 2024, analyzes common problems, and considers the concerns of customized denture products in the technical review process, providing customized denture manufacturers and related industry practitioners references, in order to further enhance the quality management system of customized denture manufacturing manufacturers, improve the quality of product registration application materials, and jointly promote the high-quality development of the industry.

, authors=Qiling Jiang, Wenqin Li*, Zhuoli Lin, authorsList=Qiling Jiang, Wenqin Li, Zhuoli Lin, authorCompany=null, correspAuthors=Wenqin Li, 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=1320388831153603415, articleId=1320388830746755925, tenantId=1146029695717560320, journalId=1319373289681944729, language=CN, title=定制式义齿生产企业注册质量管理体系核查常见问题分析及技术审评建议, columnId=1320381056239387017, journalTitle=现代仪器与医疗, columnName=医学工程, runingTitle=null, highlight=null, articleAbstract=
目的

聚焦定制式义齿生产企业注册质量管理体系核查的常见问题,开展原因分析,同时提出定制式义齿类产品的技术审评建议。

方法

采集并整理2024年广东省定制式义齿生产企业注册质量管理体系现场核查资料,分析现场核查中发现的不符合项目情况和常见问题。

结果

2024年,广东省定制式义齿生产企业开展注册质量管理体系现场核查近55家次,共计发现不符合项目243项次。对不符合项目进行统计梳理,从机构与人员,厂房、设施和设备,文件管理,设计开发,采购,生产,质量控制这7个方面对发现的常见问题进行具体分析,提出定制式义齿类产品的技术审评建议。

结论

通过总结2024年广东省定制式义齿生产企业注册质量管理体系现场核查情况,分析常见问题,思考定制式义齿产品在技术审评过程中的关注点,供定制式义齿生产企业及行业相关从业人员参考,以进一步推动定制式义齿生产企业质量管理体系的提升,提高产品注册申报资料的质量,助力产业的高质量发展。

, authors=姜祁翎, 李雯沁*, 林卓立, authorsList=姜祁翎, 李雯沁, 林卓立, authorCompany=null, correspAuthors=李雯沁, authorNote=

姜祁翎,女,本科,高级工程师,研究方向:医疗器械技术审评、检查

, correspAuthorsNote=
李雯沁,女,硕士研究生,研究方向:医疗器械技术审评、检查
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姜祁翎,女,本科,高级工程师,研究方向:医疗器械技术审评、检查

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定制式义齿生产企业注册质量管理体系核查常见问题分析及技术审评建议
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姜祁翎 , 李雯沁 * , 林卓立
现代仪器与医疗 | 医学工程 2025,31(6): 82-86
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现代仪器与医疗 |医学工程 2025 , 31 (6) : 82 -86
定制式义齿生产企业注册质量管理体系核查常见问题分析及技术审评建议
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姜祁翎, 李雯沁*, 林卓立
作者信息
  • 广东省药品监督管理局审评认证中心,广州 510080
通讯作者:
李雯沁,女,硕士研究生,研究方向:医疗器械技术审评、检查
作者简介:

姜祁翎,女,本科,高级工程师,研究方向:医疗器械技术审评、检查

Analysis of common problems on registration quality management system verification of customized denture manufacturers and technical review suggestions
Qiling Jiang, Wenqin Li*, Zhuoli Lin
Affiliations
  • Center for Certification and Evaluation, Guangdong Medical Products Administration, Guangzhou 510080, China
出版时间: 2025-12-10 doi: 10.11876/mimt202506014
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目的

聚焦定制式义齿生产企业注册质量管理体系核查的常见问题,开展原因分析,同时提出定制式义齿类产品的技术审评建议。

方法

采集并整理2024年广东省定制式义齿生产企业注册质量管理体系现场核查资料,分析现场核查中发现的不符合项目情况和常见问题。

结果

2024年,广东省定制式义齿生产企业开展注册质量管理体系现场核查近55家次,共计发现不符合项目243项次。对不符合项目进行统计梳理,从机构与人员,厂房、设施和设备,文件管理,设计开发,采购,生产,质量控制这7个方面对发现的常见问题进行具体分析,提出定制式义齿类产品的技术审评建议。

结论

通过总结2024年广东省定制式义齿生产企业注册质量管理体系现场核查情况,分析常见问题,思考定制式义齿产品在技术审评过程中的关注点,供定制式义齿生产企业及行业相关从业人员参考,以进一步推动定制式义齿生产企业质量管理体系的提升,提高产品注册申报资料的质量,助力产业的高质量发展。

定制式义齿  /  注册质量管理体系  /  不符合项目  /  技术审评
Objective

Focusing on the common problems in the registration quality management system verification of customized denture manufacturers, conducting cause analysis, and proposing technical review suggestions for customized denture products.

Methods

Collect and organize the on-site verification data of the registered quality management system of customized denture manufacturers in Guangdong Province in 2024, and analyze the non-conforming items and common problems identified during the on-site verification.

Results

In 2024, nearly 55 on-site verifications of the registered quality management system of customized denture manufacturers were conducted in the Guangdong Province, and a total of 243 non-conforming items were found. The non-conforming items were statistically sorted out, and the common problems found were specifically analyzed from seven aspects: organization and personnel, factory buildings, facilities and equipment, document management, design and development, procurement, production, and quality control, and technical review suggestions for customized denture products were put forward.

Conclusion

This article summarizes the on-site verification of the registration quality management system of customized denture manufacturers in Guangdong Province in 2024, analyzes common problems, and considers the concerns of customized denture products in the technical review process, providing customized denture manufacturers and related industry practitioners references, in order to further enhance the quality management system of customized denture manufacturing manufacturers, improve the quality of product registration application materials, and jointly promote the high-quality development of the industry.

Customized dentures  /  Registration quality management system  /  Non-conforming items  /  Technical review
姜祁翎, 李雯沁, 林卓立. 定制式义齿生产企业注册质量管理体系核查常见问题分析及技术审评建议. 现代仪器与医疗, 2025 , 31 (6) : 82 -86 . DOI: 10.11876/mimt202506014
Qiling Jiang, Wenqin Li, Zhuoli Lin. Analysis of common problems on registration quality management system verification of customized denture manufacturers and technical review suggestions[J]. Modern Instruments & Medical Treatment, 2025 , 31 (6) : 82 -86 . DOI: 10.11876/mimt202506014

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2025年第31卷第6期
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doi: 10.11876/mimt202506014
  • 首发时间:2026-10-23
  • 出版时间:2025-12-10
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    广东省药品监督管理局审评认证中心,广州 510080

通讯作者:

李雯沁,女,硕士研究生,研究方向:医疗器械技术审评、检查
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红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
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