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医疗器械2023

文化传媒2023-10-12环球律师事务所风***

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CHAMBERS GLOBAL PRACTICE GUIDES: HEALTHCARE MEDICAL DEVICES REPORT 2023

Overview:

This comprehensive guide offers comparative insights into global healthcare law, focusing specifically on medical devices regulations within China. Authored by leading experts Alan Zhou, Coco Fan, Kelly Cao, and Sylvia Dong from Global Law Office (GLO), the report delves into the nuances of product safety regulatory regimes, commercialization, enforcement mechanisms, liability frameworks, and regulator engagement.

Key Takeaways:

Regulatory Frameworks

Classification of Medical Devices: Medical devices are categorized into three classes based on risk levels—class I, II, and III—each with distinct administrative requirements by the National Medical Products Administration (NMPA).
Product Safety Regulatory Regimes: Detailed guidelines are provided for the supervision and administration of medical devices, emphasizing the importance of quality management throughout the product lifecycle.

Commercialization and Product Lifecycle

Design and Manufacture: Regulations cover aspects of design and manufacture, including compliance with Good Manufacturing Practice (GMP).
Post-Marketing Obligations: Companies must adhere to post-market obligations, corrective actions, recalls, and other regulatory requirements.

Liability and Enforcement

Product Safety Offences and Liability: The guide discusses product safety offenses and product liability, along with judicial requirements and costs associated with product-related contentious matters.
Class Actions and ADR Mechanisms: Insights into potential class actions, representative actions, coordinated proceedings, and alternative dispute resolution mechanisms are provided.

Regulator Engagement

Engagement with Regulatory Authorities: Guidance on interacting with regulatory bodies, including the NMPA and other relevant authorities, is included.

Impact of Artificial Intelligence

AI's Influence: The guide explores how advancements in AI impact the healthcare sector and compliance considerations.

Industry Background

GLO's Role: Founded in 1979, GLO is recognized as one of the largest Chinese law firms, providing "one-stop" legal services to the life sciences and healthcare industry. Its team combines international experience with local expertise to support innovative projects.

Author Profiles

Alan Zhou: A leading partner in GLO's life sciences and healthcare practice, known for his work advising multinational corporations on legislative issues.
Coco Fan: Specializes in corporate, compliance, private equity, venture capital, and M&A, with extensive experience across various healthcare sectors.
Kelly Cao: Expertise in dispute resolution, compliance, risk control, labor employment, and litigation assistance for major life sciences companies.
Sylvia Dong: Focuses on M&A, private equity/venture capital, capital markets, and life sciences industry investments, representing clients in complex transactions.

Conclusion

The report serves as a valuable resource for understanding the complexities of medical device regulations and commercialization within China, offering insights into compliance, liability, and enforcement mechanisms, alongside strategic guidance for engaging with regulators and navigating legal challenges.

CHAMBERSGLOBALPRACTICEGUIDES Healthcare: MedicalDevices2023 Definitivegloballawguidesofferingcomparativeanalysisfromtop-rankedlawyers China:LawandPractice AlanZhou,CocoFan,KellyCaoandSylviaDong GlobalLawOffice(GLO) CHINA LawandPractice Contributedby: AlanZhou,CocoFan,KellyCaoandSylviaDong GlobalLawOffice(GLO) 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.12 2.4MarketingandSalesp.15 2.5Internationalisationp.18 2.6Post-marketingObligations,IncludingCorrectiveActionsandRecallsp.19 3.RegulatorEngagementandEnforcementp.21 3.1RegulatoryAuthoritiesp.21 3.2RegulatoryEnforcementMechanismsp.22 4.Liabilityp.22 4.1ProductSafetyOffencesp.22 4.2ProductLiabilityp.23 4.3JudicialRequirementsp.24 4.4Costsp.25 4.5Product-RelatedContentiousMattersp.25 4.6ClassActions,RepresentativeActionsorCo-ordinatedProceedingsp.25 4.7ADRMechanismsp.26 4.8InterrelationBetweenLiabilityMechanismsp.26 5.ApplicableProductSafetyRegulatoryRegimesp.27 5.1PolicyDevelopmentp.27 5.2LegislativeReformp.28 5.3ImpactofArtificialIntelligencep.29 GlobalLawOffice(GLO)datesbacktotheestablishmentofChina’sLegalConsultantOf-ficeoftheCouncilforthePromotionofInterna-tionalTradein1979.GLOhasbecomeoneofthelargestandleadingChineselawfirms,withmorethan500lawyerspractisinginitsBeijing,Shanghai,Shenzhen,andChengduoffices.Itslifesciencesandhealthcare(L&H)practicegroupisoneoftheearliestL&HteamsinChina,havingprovided“one-stop”legalservicesforeveryareaoftheL&Hindustry,includingM&A,investmentandfunding,licenceinandout,daily operation,IPprotection,andadviceoncompli-anceincludinginternalandgovernmentinvesti-gationsaswellasanti-briberymattersanddis-putesettlement.Underachangingregulatoryenvironment,GLO’sL&Hteamhastheperfectcombinationofinternationalexperienceandlo-calknow-howtosupportvariousinnovationorpilotprojects,includingdigitalhealthcareandMAH/CMAHtrialcases.GLO’sL&Hteamdeep-lyparticipatesintheformulationoflocalcodesofconductandbenchmarkpolicies/rules. Authors AlanZhouistheleadingpartnerofthelifesciencesandhealthcare(L&H)practicegroupatGlobalLawOffice,withastrongbackgroundinL&H.MrZhouroutinelyrepresents CocoFanisapartnerofthelifesciencesandhealthcare(L&H)practicegroupatGlobalLawOffice.Shespecialisesincorporate,compliance,privateequityandventurecapital,and multinationalcorporations,well-knownChinesestate-ownedandprivateenterprises,andprivateequity/venturecapitalfundsintheL&Harea.HehasbeenengagedbylocalauthoritiesandindustrialassociationstoadviseonlegislationandindustrystandardsintheL&Hindustry,includingtheformulationofthecomplianceguidelinesforthehealthcareindustry,thetextbookforCorporateComplianceOfficerProfessionalSkillStandards,e-healthcare,medicalinsurancereform,andmedicalrepresentativeadministration.MrZhouhaswonnumerousawardsintheworld’sleadinglawyersrankings,andisapublishedauthor. M&A,andshehasrichexperienceintheL&Hpractice.Thisincludesprescriptionmedicine,over-the-countermedicine,contractresearchorganisations,medicaldevices,biopharmaceuticals,healthfoods,clinicalsupply,vaccines,animalhealth,andhospitals.MsFanhasadvisedmanymultinationalcompanies,privatecompanies,andinvestorswithrespecttoriskassessmentandhealthchecks,andtailoredtrainingfromanti-corruption,antitrust,promotion,andotherregulatorycomplianceperspectives.Shealsoadvisesontheestablishmentofpharmaceuticalandmedicaldeviceindustrycompliancemanagementstandards. Contributedby:AlanZhou,CocoFan,KellyCaoandSylviaDong,GlobalLawOffice(GLO) KellyCaoisapartnerofthelifesciencesandhealthcare(L&H)practicegroupatGlobalLawOffice.Hermainpracticeareasencompassdisputeresolution,compliance,andriskcontrol,as wellaslabourandemployment.MsCaohasadvisedmajorlifesciencescompaniesongeneralcomplianceanddisputeresolution,andassistsmultinationalenterprisesandwell-knowndomesticenterpriseswiththeirdisputesinlitigationandarbitration.MsCaoalsoprovideslegalservicestomultinationalpharmaceuticalcorporations,assistingwiththeircompliancesystemestablishmentandinternalcomplianceinvestigations. SylviaDongisanofcounselatGlobalLawOffice.HermainpracticecoversM&A,privateequity/venturecapitalandthecapitalmarket,andsheisespeciallyfocusedonthelife sciencesindustry.Shehasrepresentedwell-knownclientsinvariousdomesticandcross-bordertransactions,strategicinvestments,andcollaborations,aswellassecuritiesofferingsandbondofferings.Shehasgreatexperienceininvestments,licencedeals,businesscollaborations,generalcorporate,andcomplianceinthelifesciencesandhealthcareindustries. GlobalLawOffice 36thFloorShanghaiOneICC No999MiddleHuaiHaiRoadXuhuiDistrict Shanghai200031China Tel:+862123108200 Fax:+862123108299 Email:Alanzhou@glo.com.cnWeb:www.glo.com.cn 1.ApplicableProductSafety RegulatoryRegimes 1.1MedicalDevices ProductSafetyRegulatoryRegimeforMedicalDevices Clas

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