《医疗器械》中国篇（英）.pdf

CHAMBERS GLOBAL PRACTICE GUIDESHealthcare:Medical Devices 2024Definitive global law guides offering comparative analysis from top-ranked lawyersChina:Law and Practice Alan Zhou,Coco Fan and Kelly Cao Global Law OfficeCHINA2CHAMBERS.COMLaw and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao Global Law OfficeContents1.Applicable Product Safety Regulatory Regimes p.51.1 Medical Devices p.51.2 Healthcare Products p.61.3 Medicines p.71.4 Technologies and Digital Health p.81.5 Borderline Products p.92.Commercialisation and Product Life Cycle p.102.1 Design and Manufacture p.102.2 Corporate Social Responsibility,the Environment and Sustainability p.122.3 Advertising and Product Claims p.132.4 Marketing and Sales p.152.5 Internationalisation p.182.6 Post-marketing Obligations,Including Corrective Actions and Recalls p.203.Regulator Engagement and Enforcement p.223.1 Regulatory Authorities p.223.2 Regulatory Enforcement Mechanisms p.234.Liability p.234.1 ProductSafetyOffencesp.234.2 Product Liability p.244.3 Judicial Requirements p.254.4 Costs p.254.5 Product-Related Contentious Matters p.264.6 Class Actions,Representative Actions or Co-ordinated Proceedings p.264.7 ADR Mechanisms p.274.8 Interrelation Between Liability Mechanisms p.275.Applicable Product Safety Regulatory Regimes p.285.1 Policy Development p.285.2 Legislative Reform p.295.3 ImpactofArtificialIntelligencep.30CHINA Law and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao,Global Law Office 3CHAMBERS.COMGlobal Law Office dates back to the establish-ment of Chinas Legal Consultant Office of the Council for the Promotion of International Trade in 1979.GLO has become one of the largest and leading Chinese law firms,with more than 500 lawyers practising in its Beijing,Shanghai,Shenzhen,and Chengdu offices.Its life scienc-es and healthcare(L&H)practice group is one of the earliest L&H teams in China,having pro-vided“one-stop”legal services for every area of the L&H industry,including M&A,investment and funding,licence in and out,daily operation,IP protection,and advice on compliance includ-ing internal and government investigations as well as anti-bribery matters and dispute settle-ment.Under a changing regulatory environment,GLOs L&H team has the perfect combination of international experience and local know-how to support various innovation and pilot projects,including digital healthcare and MAH/CMAH trial cases.GLOs L&H team deeply participates in the formulation of local codes of conduct and benchmark policies/rules.AuthorsAlan Zhou is the leading partner of the life sciences and healthcare(L&H)practice group at Global Law Office,with a strong background in L&H.Mr Zhou routinely represents multinational corporations,well-known Chinese state-owned and private enterprises,and private equity/venture capital funds in the L&H area.He has been engaged by local authorities and industrial associations to advise on legislation and industry standards in the L&H industry,including the formulation of the compliance guidelines for the healthcare industry,the textbook for Corporate Compliance Officer Professional Skill Standards,e-healthcare,medical insurance reform,and medical representative administration.Mr Zhou has won numerous awards from the worlds leading legal ranking firms,and is a published author.Coco Fan is a partner of the life sciences and healthcare(L&H)practice group at Global Law Office.She specialises in corporate,compliance,private equity and venture capital,and M&A,and she has rich experience in the L&H practice.This includes prescription medicine,over-the-counter medicine,contract research organisations,medical devices,biopharmaceuticals,health foods,clinical supply,vaccines,animal health,and hospitals.Ms Fan has advised many multinational companies,private companies,and investors with respect to risk assessment and health checks,and tailored training from anti-corruption,antitrust,promotion,and other regulatory compliance perspectives.She also advises on the establishment of pharmaceutical and medical device industry compliance management standards.CHINA Law and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao,Global Law Office 4CHAMBERS.COMKelly Cao is a partner of the life sciences and healthcare(L&H)practice group at Global Law Office.Her main practice areas encompass dispute resolution,compliance,and risk control,as well as labour and employment.Ms Cao has advised major life sciences companies on general compliance and dispute resolution,and assists multinational enterprises and well-known domestic enterprises with their disputes in litigation and arbitration.Ms Cao also provides legal services to multinational pharmaceutical corporations,assisting with their compliance system establishment and internal compliance investigations.Global Law Office36th FloorShanghai One ICCNo 999 Middle Huai Hai RoadXuhui DistrictShanghai 200031ChinaTel:[phone]Fax:[phone]Email:alanzhouWeb:CHINA Law and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao,Global Law Office 5CHAMBERS.COM1.Applicable Product Safety Regulatory Regimes1.1 Medical DevicesProduct Safety Regulatory Regime for Medical DevicesClassification of medical devicesUnder the PRCs legal regime,“medical devices”refers to instruments,equipment,appliances,in vitro diagnostic reagents and calibrators,materi-als,and other similar or relevant articles including necessary computer software that are directly or indirectly used for the diagnosis,prevention,monitoring,treatment or relief of diseases or inju-ry,the functional compensation of injuries,the inspection,substitution,adjustment,or support of physiological structures or physiological pro-cesses,the control of pregnancy,or the support or maintenance of life.Unlike a pharmaceutical product,the utility of medical devices is mainly achieved by physical or other means rather than pharmacological,immunological,or metabolic means,or where the latter means only acting as auxiliary functions.“Medical instrument”is not a legally defined term under the PRCs laws.Gen-erally,medical instruments would be interpreted as being the same as medical devices.Activities relating to medical devices have been strictly regulated in the PRC,and the regula-tions that apply to a medical device in the PRC depend on how that medical device is classified.Medical devices are categorised into three class-es according to their risk levels.The National Medical Products Administration(NMPA)deter-mines a medical devices risk level according to its intended purposes,structural features,the form of use,whether it is in contact with,or has access to,the human body,and other factors.In general:class I medical devices refer to those that have a low degree of risk and whose safety and effectiveness can be ensured through routine administration,and therefore they are merely subject to a record-filing administra-tion under the supervision of the NMPA and its local counterparts;class II medical devices refer to those with a medium degree of risk;and class III medical devices refer to those with the highest risk level,the safety and effective-ness of which need to be ensured by strict control and regulation,and therefore are subject to registration administration under the supervision of the NMPA.The NMPA has issued the Rules for Medical Device Classification,the Catalogue of Medical Device Classification,the Catalogue of Class I Medical Device Products,the Rules for In Vit-ro Diagnostic Reagents Classification and the Catalogue of In Vitro Diagnostic Reagents Clas-sification to guide this classification of medical devices.Regulations of medical devicesThe Regulations for the Supervision and Admin-istration of Medical Devices(RSAMD)set up the regulatory framework for the administration of medical devices.The development,registra-tion,manufacturing,and distribution of medical devices are regulated by more detailed GxP rules and administrative measures,such as Good Manufacturing Practice,Good Clinical Practice,and Good Supply Practice for Medical Devices.Subject to the classification of the medical devic-es,the registrants or the record-filing holders of the medical devices(ie,the marketing authori-sation holders(MAHs)of the medical devices)are responsible for the quality management of the whole life cycle of medical devices and are CHINA Law and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao,Global Law Office 6CHAMBERS.COMresponsible for the safety and effectiveness of medical devices in the whole process of the development,manufacturing,distribution,and use of such medical devices according to appli-cable laws and regulations.Those who wish to engage in clinical trials,or the manufacturing or distribution of medical devices,must also obtain a permit or approval,which is discussed in 2.Commercialisation and Product Life Cycle.Software-Based Medical DevicesSee 1.4 Technologies and Digital Health.Product Safety Regulatory Regime for Personal Protective Equipment(PPE)PPE is not a defined legal term under PRC laws.There are specific requirements for“special labour protection articles”,which include safety nets,safety helmets,building fasteners,and other products that ensure labour safety.The current regulations on special labour protection articles are less stringent than the regulations for medical devices.Unlike medical devices,busi-ness operators do not need to obtain special permits or licences for the registration,manu-facturing,or distribution of special labour pro-tection articles.The government implements a third-party voluntary certification system for attaching safety signs on special labour protec-tion articles,and the production,circulation,and use of such special labour protection articles are subject to enhanced supervision by the State Administration for Market Regulation and its local counterparts(collectively,AMR)beyond ordinary products,by means of spot checks of product quality and on-site supervision for the use of such special labour protection articles.If the protective articles used by medical staff fall within the scope of medical devices,such as medical protective respirators and medical protective clothing,they are regulated as medi-cal devices.General labour protection articles and other personal protective equipment are deemed to be ordinary products with no special regulatory requirements for their marketing,manufacturing,and distribution.1.2 Healthcare ProductsProduct Safety Regulatory Regime for Healthcare ProductsCosmetics are governed by administrative regu-lations,ranging from manufacturing to market-ing,business operation,and post-market moni-toring.The Regulations on the Supervision and Regulation of Cosmetics are the most significant regulations in the hierarchy,which apply a Clas-sification Supervision System to cosmetics.Special cosmetics,referring to cosmetics that claim new efficacy,must be registered with the competent authorities before manufactur-ing and import.Ordinary cosmetics(cosmetics other than special cosmetics)need only to be record-filed.Biocides fall under the legislative regime of pes-ticides and thus must comply with the strictly regulated system for pesticides.According to the Regulations on Pesticide Administration,for the manufacturing,marketing,and business operation of pesticides,corresponding licences must be obtained from the competent authori-ties.Post-market monitoring of pesticides is also a highly regulated area.Food(including GMOs)is classified as either conventional food or special food,and the latter covers health food.Health food refers to food with specific healthcare functions,which means CHINA Law and PracticeContributed by:Alan Zhou,Coco Fan and Kelly Cao,Global Law Office 7CHAMBERS.COMfood that is suitable for specific groups of per-sons due to its functions for body regulation,but not for the purpose of disease treatment,and includes nutrition supplements.The Food Safety Law regulates the production,distribution,safe-ty,labels,inspection,and import and export of food products,and there are many specific regu-lations regulating different kinds of food,such as the Administrative Measures for Registration and Record-filing of Health Food,and the Regula-tions on Administration of Agricultural Geneti-cally Modified Organisms Safety.Thus,nutrition supplements must follow the Food Safety Law and are subject to special regulations for health food,which are named the Catalogue Manage-ment System under Administrative Measures for the Catalogue of Ingredients and the Catalogue of Healthcare Functions of Health Food.1.3 Medicines“Pharmaceuticals”,“medicines”and“drugs”refer to substances that are used to prevent,treat,or diagnose human diseases and are intended to regulate human physiological functions,for which the usage and dosage are specified for indication or primary treatment.The fundamen-tal law regulating pharmaceuticals in China is the Drug Administration Law(DAL),which governs various drug-related activities,including their development,registration,manufacturing,and distribution.Clinical trials of pharmaceuticals are regulated by laws and an array of guidance and techni-cal review standards.Specifically,the DAL,the Administrative Measures for Drug Registration(2020 Revision),and the Good Clinical Practice(GCP)outline the framework for administration on clinical trials of pharmaceuticals,and specify the detailed obligations of the parties involved,operational procedures,and technical require-ments.Details on the regulation of pharmaceuticals and relevant clinical trials can be viewed in the Chinese Law and Practice chapter in the 2024 Chambers Life Sciences Global Practice Guide.Blood ProductsUnder the PRCs legal regime,blood products refer to,in particular,various human plasma protein products,which are governed as phar-maceuticals,and further as biological medicinal products.As a special category of medicinal products,in addition to the regulations gener-ally applicable to drugs,blood products are also subject to the Regulations on the Administration of Blood Products and other special regulatory requirements.For instance,the source plasma for the production of blood products shall only be obtained from a qualified supplier,blood products are generally subject to batch release administration prior to marketing,and blood products shall not be contracted for manufac-ture or sold online.China is accelerating the informatisation construction of the blood prod-uct production and inspection processes.The NMPA has issued the Smart Supervision Three-Year Action Plan for Blood Product Production(20242026),aiming to essentially achieve infor-matised management in blood product produc-tion enterprises by the end of 2026.Psychedelics“Psychedelics”is not a defined legal term under the PRC laws.Generally,psychedelics refer to materials that stimulate the central nervous sys-tem and cause false sensations,changes in tem-perament,increased pulse rate,increased blood pressure and body temper