医疗健康：医疗器械2025-中国篇（英）.pdfVIP

CHAMBERSGLOBALPRACTICEGUIDES

Healthcare:

MedicalDevices2025

Definitivegloballawguidesoffering

comparativeanalysisfromtop-rankedlawyers

China:LawPractice

AlanZhou,CocoFanandKellyCao

GlobalLawOffice

CHINA

LawandPractice

Contributedby:

AlanZhou,CocoFanandKellyCao

GlobalLawOffice

Contents

1.ApplicableProductSafetyRegulatoryRegimesp.4

1.1MedicalDevicesp.4

1.2HealthcareProductsp.5

1.3Medicinesp.5

1.4TechnologiesandDigitalHealthp.6

1.5BorderlineProductsp.7

2.CommercialisationandProductLifeCyclep.8

2.1DesignandManufacturep.8

2.2CorporateSocialResponsibility,theEnvironmentandSustainabilityp.10

2.3AdvertisingandProductClaimsp.10

2.4MarketingandSalesp.12

2.5Internationalisationp.15

2.6Post-MarketingObligations,IncludingCorrectiveActionsandRecallsp.16

3.RegulatorEngagementandEnforcementp.17

3.1RegulatoryAuthoritiesp.17

3.2RegulatoryEnforcementMechanismsp.19

4.Liabilityp.19

4.1 Product Safety Offences p.19

4.2ProductLiabilityp.19

4.3JudicialRequirementsp.20

4.4Costsp.20

4.5Product-RelatedContentiousMattersp.20

4.6ClassActions,RepresentativeActionsorCo-OrdinatedProceedingsp.21

4.7ADRMechanismsp.21

4.8InterrelationBetweenLiabilityMechanismsp.21

5.ApplicableProductSafetyRegulatoryRegimesp.22

5.1PolicyDevelopmentp.22

5.2LegislativeReformp.23

5.3 Impact of Artificial Intelligence p.23

2CHAMBERS.COM

CHINALawandPractice

Contributedby:AlanZhou,CocoFanandKellyCao,GlobalLawOffice

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