医疗器械-中国篇Healthcare Medical Devices 2024.docx

下载文档

0
0
约9.81万字
约 63页
2024-10-17 发布于山西
举报
版权申诉
保障服务

医疗器械-中国篇Healthcare Medical Devices 2024.docx

此“医疗卫生”领域文档为创作者个人分享资料，不作为权威性指导和指引，仅供参考

1、本文档共63页，可阅读全部内容。
2、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。
3、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。

CHAMBERSGLOBALPRACTICEGUIDES

Healthcare:MedicalDevices2024

Definitivegloballawguidesoffering

comparativeanalysisfromtop-rankedlawyers

China:LawandPractice

AlanZhou,CocoFanandKellyCaoGlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CocoFanandKellyCao

GlobalLawOffice

Contents

1.ApplicableProductSafetyRegulatoryRegimesp.5

1.1MedicalDevicesp.5

1.2HealthcareProductsp.6

1.3Medicinesp.7

1.4TechnologiesandDigitalHealthp.8

1.5BorderlineProductsp.9

2.CommercialisationandProductLifeCyclep.10

2.1DesignandManufacturep.10

2.2CorporateSocialResponsibility,theEnvironmentandSustainabilityp.12

2.3AdvertisingandProductClaimsp.13

2.4MarketingandSalesp.15

2.5Internationalisationp.18

2.6Post-marketingObligations,IncludingCorrectiveActionsandRecallsp.20

3.RegulatorEngagementandEnforcementp.22

3.1RegulatoryAuthoritiesp.22

3.2RegulatoryEnforcementMechanismsp.23

4.Liabilityp.23

4.1ProductSafetyOffencesp.23

4.2ProductLiabilityp.24

4.3JudicialRequirementsp.25

4.4Costsp.25

4.5Product-RelatedContentiousMattersp.26

4.6ClassActions,RepresentativeActionsorCo-ordinatedProceedingsp.26

4.7ADRMechanismsp.27

4.8InterrelationBetweenLiabilityMechanismsp.27

5.ApplicableProductSafetyRegulatoryRegimesp.28

5.1PolicyDevelopmentp.28

5.2LegislativeReformp.29

5.3ImpactofArtificialIntelligencep.30

2CHAMBERS.COM

CHINALawandPractice

Contributedby:AlanZhou,CocoFanandKellyCao,GlobalLawOffice

GlobalLawOfficedatesbacktotheestablish-mentofChina’sLegalConsultantOfficeoftheCouncilforthePromotionofInternationalTradein1979.GLOhasbecomeoneofthelargestandleadingChineselawfirms,withmorethan500lawyerspractisinginitsBeijing,Shanghai,Shenzhen,andChengduoffices.Itslifescienc-esandhe