Regulations for the Supervision and Administration of Medical Devices (2021 Revision)

# Regulations for the Supervision and Administration of Medical Devices (2021 Revision)**Order of the State Council of the People’s Republic of China No. 739**The *Regulations for the Supervision and Administration of Medical Devices*, revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020, is hereby promulgated and shall come into force on June 1, 2021.Premier: Li KeqiangFebruary 9, 2021(Promulgated by Order No. 276 of the State Council on January 4, 2000; revised and adopted at the 39th Executive Meeting of the State Council on February 12, 2014; revised in accordance with the *Decision of the State Council on Amending the Regulations for the Supervision and Administration of Medical Devices* on May 4, 2017; revised and adopted at the 119th Executive Meeting of the State Council on December 21, 2020)## Chapter I General Provisions**Article 1** These Regulations are formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry.**Article 2** These Regulations apply to the research and development, production, operation, use, and supervision and administration of medical devices within the territory of the People’s Republic of China.**Article 3** The drug regulatory department under the State Council shall be responsible for the nationwide supervision and administration of medical devices.Relevant departments under the State Council shall be responsible for the supervision and administration related to medical devices within their respective functions and responsibilities.**Article 4** Local people’s governments at or above the county level shall strengthen leadership over the supervision and administration of medical devices in their respective administrative regions, organize and coordinate supervision and administration and emergency response, enhance regulatory capacity, and provide guarantees for medical device safety.Drug regulatory departments of local people’s governments at or above the county level shall be responsible for the supervision and administration of medical devices in their respective administrative regions. Relevant departments of local people’s governments at or above the county level shall be responsible for the supervision and administration related to medical devices within their respective functions and responsibilities.**Article 5** The supervision and administration of medical devices shall follow the principles of risk management, whole‑process control, scientific regulation, and social co‑governance.**Article 6** The State implements classified administration of medical devices based on their risk levels:- Class I: Low‑risk medical devices whose safety and effectiveness can be ensured through routine administration.- Class II: Medium‑risk medical devices that require strict control and administration to ensure safety and effectiveness.- Class III: High‑risk medical devices that require special measures for strict control and administration to ensure safety and effectiveness.The risk level of a medical device shall be evaluated considering its intended purpose, structural characteristics, method of use, and other factors.The drug regulatory department under the State Council shall formulate classification rules and catalogs for medical devices, timely analyze and evaluate risk changes based on production, operation, and use, and adjust the rules and catalogs accordingly. The formulation and adjustment shall fully solicit opinions from registrants, filers, manufacturers, operators, users, and industry organizations, and reference international classification practices. Classification rules and catalogs shall be released to the public.**Article 7** Medical devices shall comply with mandatory national standards; where no such standards exist, they shall comply with mandatory industrial standards for medical devices.**Article 8** The State formulates industrial plans and policies for medical devices, prioritizes innovation in review and approval, supports clinical promotion and application of innovative medical devices, and drives high‑quality development. The drug regulatory department under the State Council shall cooperate with relevant departments to implement such plans and policies.**Article 9** The State improves the medical device innovation system, supports basic and applied research, promotes new technologies, and provides support in project approval, financing, credit, tendering and procurement, and medical insurance. Enterprises are encouraged to establish or jointly set up R&D institutions and cooperate with universities, research institutes, and medical institutions. Intellectual property protection is strengthened to enhance independent innovation capacity.**Article 10** The State strengthens information‑based supervision and administration, improves online government services, and facilitates administrative licensing and filing for medical devices.**Article 11** Medical device industry organizations shall strengthen self‑regulation, promote integrity systems, urge enterprises to operate in accordance with laws, and guide honest practices.**Article 12** Units and individuals making outstanding contributions to medical device R&D and innovation shall be commended and rewarded in accordance with relevant national provisions.## Chapter II Registration and Filing of Medical Devices**Article 13** Class I medical devices are subject to product filing administration; Class II and Class III medical devices are subject to product registration administration.Medical device registrants and filers shall strengthen full‑life‑cycle quality management and bear legal responsibility for the safety and effectiveness of medical devices throughout R&D, production, operation, and use.**Article 14** The following documents shall be submitted for filing of Class I medical devices and application for registration of Class II and Class III medical devices:1. Product risk analysis documents;2. Product technical requirements;3. Product inspection reports;4. Clinical evaluation documents;5. Drafts of product instructions and labels;6. Quality management system documents related to product R&D and production;7. Other documents necessary to prove product safety and effectiveness.Product inspection reports shall meet requirements of the drug regulatory department under the State Council, and may be self‑inspection reports or reports issued by qualified inspection institutions.Clinical evaluation documents may be exempted if falling under the exemption provisions in Article 24.Applicants and filers shall ensure submitted documents are lawful, authentic, accurate, complete, and traceable.**Article 15** Filing for Class I medical devices shall be submitted by the filer to the drug regulatory department of the city divided into districts where the filer is located.Overseas filers exporting Class I medical devices into China shall entrust a Chinese enterprise legal person to submit filing documents and proof of marketing authorization from the competent authority of the filer’s country/region. Innovative medical devices not yet marketed overseas may be exempt from such proof.Filing is completed upon submission of compliant documents. The drug regulatory department shall publish filing information via the online platform within 5 working days of receipt.Changes to recorded information shall be filed for amendment with the original authority.**Article 16** Applications for registration of Class II medical devices shall be submitted to the provincial‑level drug regulatory department; applications for Class III medical devices shall be submitted to the drug regulatory department under the State Council.Overseas applicants exporting Class II and Class III medical devices into China shall entrust a Chinese enterprise legal person to submit registration documents and proof of marketing authorization from the applicant’s country/region. Innovative medical devices not yet marketed overseas may be exempt from such proof.The drug regulatory department under the State Council shall stipulate registration review procedures and requirements, and supervise and guide provincial‑level review work.**Article 17** The accepting drug regulatory department shall review the safety, effectiveness, and quality management capacity of the applicant.The department shall transfer application documents to the technical evaluation institution within 3 working days of acceptance. The technical evaluation institution shall submit evaluation opinions as the basis for approval upon completion of evaluation.Where necessary to verify the quality management system during technical evaluation, the department shall organize such verification.**Article 18** The accepting drug regulatory department shall make a decision within 20 working days of receiving evaluation opinions. Qualified applications shall be approved and issued a registration certificate; unqualified applications shall be rejected with written reasons.Registration information shall be published via the online platform within 5 working days of approval.**Article 19** For urgently needed medical devices for rare diseases, life‑threatening diseases with no effective treatment, or public health emergencies, conditional approval may be granted and noted on the registration certificate.In major public health emergencies or serious threats to public health, the health authority under the State Council may propose emergency use; upon demonstration and approval by the drug regulatory department under the State Council, emergency use may be authorized within a specified scope and period.**Article 20** Medical device registrants and filers shall fulfill the following obligations:1. Establish and maintain an effective quality management system adapted to the product;2. Formulate and implement post‑market research and risk control plans;3. Conduct adverse event monitoring and re‑evaluation in accordance with laws;4. Establish and implement product traceability and recall systems;5. Other obligations stipulated by the drug regulatory department under the State Council.Chinese enterprise legal persons entrusted by overseas registrants and filers shall assist in fulfilling the above obligations.**Article 21** For registered Class II and Class III medical devices, substantive changes to design, raw materials, production processes, intended use, or method of use that may affect safety and effectiveness shall require registration amendment; other changes shall be filed or reported in accordance with regulations.**Article 22** A medical device registration certificate is valid for 5 years. Applications for renewal shall be submitted 6 months before expiration.The authority shall approve renewal before expiration except for the following circumstances:1. Failure to apply within the prescribed time limit;2. Inability to meet revised mandatory standards;3. Failure to complete conditional approval requirements within the prescribed period.Failure to make a decision within the time limit shall be deemed approval of renewal.**Article 23** For newly developed medical devices not listed in the classification catalog, applicants may directly apply for Class III registration, or apply for category confirmation from the drug regulatory department under the State Council and then proceed with registration or filing.For direct Class III applications, the department shall determine the category by risk level and include approved devices in the catalog. Category confirmation shall be completed and notified within 20 working days of acceptance.**Article 24** Clinical evaluation is required for registration or filing, except in the following cases:1. Clear mechanism, finalized design, mature production process, long‑term clinical use of equivalent devices with no serious adverse events, and no change in conventional intended use;2. Other cases where safety and effectiveness can be proven through non‑clinical evaluation.The drug regulatory department under the State Council shall formulate clinical evaluation guidelines.**Article 25** Clinical evaluation may be conducted via clinical trials, or analysis of clinical literature and data of equivalent devices, based on product characteristics, clinical risk, and existing data.Where existing data are insufficient to confirm safety and effectiveness, clinical trials shall be conducted.**Article 26** Clinical trials shall comply with good clinical practice, be carried out in qualified institutions, and filed with the provincial‑level drug regulatory department of the sponsor’s location. The filing authority shall notify the counterpart drug and health authorities of the trial institution’s location.Clinical trial institutions are subject to filing administration. Qualifications, filing measures, and good clinical practice shall be formulated and issued jointly by the drug regulatory and health authorities under the State Council.The State supports clinical trials and includes trial capacity in hospital accreditation.**Article 27** High‑risk Class III clinical trials shall be approved by the drug regulatory department under the State Council. Approval shall be based on comprehensive analysis of institutional conditions, product risk, trial protocol, and benefit‑risk assessment, and decided within 60 working days of acceptance; silence shall constitute approval. Approval shall be notified to the provincial‑level drug and health authorities of the trial institution’s location.The catalog of high‑risk Class III clinical trials shall be formulated and adjusted by the drug regulatory department under the State Council.**Article 28** Clinical trials shall undergo ethical review; informed written consent shall be obtained from subjects, or from guardians for persons without or with limited capacity for civil conduct.No fees related to trials shall be charged to subjects.**Article 29** For investigational devices for life‑threatening diseases with no effective treatment, free compassionate use in the same trial institution may be allowed after ethical review and informed consent if clinically beneficial; safety data may be used for registration applications.## Chapter III Production of Medical Devices**Article 30** Entities engaged in medical device production shall meet the following conditions:1. Appropriate production premises, environment, equipment, and professional personnel;2. Quality inspection机构 or full‑time inspectors and equipment;3. Quality management systems ensuring product quality;4. After‑sales service capacity adapted to the products;5. Compliance with R&D and production process documents.**Article 31** Production of Class I medical devices shall be filed with the drug regulatory department of the city divided into districts where the producer is located. Filing is completed upon submission of compliant documents.Filers producing their own Class I devices may submit production documents together with product filing.**Article 32** Production of Class II and Class III medical devices shall obtain a production license from the provincial‑level drug regulatory department, submitting qualification documents and registration certificates.The authority shall review documents, verify compliance with good manufacturing practice, and decide within 20 working days of acceptance. Qualified applications shall be issued a production license; unqualified applications shall be rejected with written reasons.A production license is valid for 5 years; renewal shall follow administrative licensing laws.**Article 33** Good manufacturing practice shall specify requirements for design and development, production conditions, raw material procurement, process control, product release, organizational structure, and staffing affecting safety and effectiveness.**Article 34** Registrants and filers may produce medical devices by themselves or entrust qualified enterprises.Registrants and filers shall be responsible for product quality, supervise entrusted producers, and sign agreements clarifying rights and obligations. Entrusted producers shall produce in accordance with laws, good manufacturing practice, mandatory standards, technical requirements, and agreements, and accept supervision.High‑risk implantable medical devices shall not be entrusted for production; the specific catalog shall be formulated and adjusted by the drug regulatory department under the State Council.**Article 35** Registrants, filers, and entrusted producers shall establish and maintain an effective quality management system in accordance with good manufacturing practice, produce strictly in line with registered or filed technical requirements, and ensure factory products comply with mandatory standards and technical requirements.Regular self‑inspections of the quality management system shall be conducted, and self‑inspection reports submitted in accordance with regulations.**Article 36** If production conditions no longer meet quality management system requirements, immediate rectification shall be taken; if safety or effectiveness may be affected, production shall be suspended and reported to the original licensing or filing authority.**Article 37** Medical devices shall use generic names in compliance with naming rules formulated by the drug regulatory department under the State Council.**Article 38** The State implements a unique device identification system by category to ensure traceability; specific measures shall be formulated jointly by the drug regulatory department under the State Council and relevant departments.**Article 39** Medical devices shall have instructions and labels consistent with registered or filed content, truthful and accurate.Instructions and labels shall indicate:1. Generic name, model, and specification;2. Name, address, and contact information of registrant, filer, and entrusted producer;3. Production date, service life or expiration date;4. Product performance, main structure, and intended use;5. Contraindications, precautions, and warnings;6. Installation and use instructions or diagrams;7. Maintenance, special transportation, and storage conditions;8. Other items required by product technical requirements.Class II and Class III devices shall also indicate the registration certificate number.Devices for consumer self‑use shall include special safety instructions.## Chapter IV Operation and Use of Medical Devices**Article 40** Entities engaged in medical device operation shall have appropriate premises, storage conditions, quality management systems, and institutions or personnel adapted to the business scale and scope.**Article 41** Operation of Class II medical devices shall be filed with the drug regulatory department of the city divided into districts where the operator is located, submitting compliant documents.Class II devices whose safety and effectiveness are not affected by circulation may be exempt from filing in accordance with regulations.**Article 42** Operation of Class III medical devices shall obtain an operation license from the drug regulatory department of the city divided into districts where the operator is located, submitting compliant documents.The authority shall review documents, conduct verification if necessary, and decide within 20 working days of acceptance. Qualified applications shall be issued an operation license; unqualified applications shall be rejected with written reasons.An operation license is valid for 5 years; renewal shall follow administrative licensing laws.**Article 43** Registrants and filers operating their own registered or filed devices are exempt from operation licensing or filing, but shall meet prescribed operation conditions.**Article 44** Operators shall establish and maintain an effective quality management system in accordance with laws and good distribution practice formulated by the drug regulatory department under the State Council.**Article 45** Operators and users shall purchase medical devices from qualified registrants, filers, manufacturers, and operators.Incoming inspection records shall be established, verifying supplier qualifications and conformity certificates. Wholesale operators of Class II and Class III devices and retail operators of Class III devices shall also establish sales records.Records shall include:1. Name, model, specification, and quantity;2. Production batch number, service life or expiration date, sales date;3. Name of registrant, filer, and entrusted producer;4. Name, address, and contact information of supplier or purchaser;5. License numbers.Records shall be truthful, accurate, complete, traceable, and retained for the prescribed period. Advanced recording technologies are encouraged.**Article 46** Online sales shall be conducted by registrants, filers, or operators. Relevant information shall be reported to the drug regulatory department of the city divided into districts where the operator is located, except for Class I and exempt Class II devices.E‑commerce platforms shall conduct real‑name registration, verify licenses and registrations/filings, and manage operations. Violations shall be stopped and reported; serious violations shall result in immediate suspension of platform services.**Article 47** Transportation and storage shall comply with instructions and labels; special environmental requirements shall be met to ensure safety and effectiveness.**Article 48** Users shall have appropriate storage places and conditions. Staff training shall be strengthened for proper use in accordance with instructions and specifications.Allocation of large medical equipment shall comply with planning formulated by the health authority under the State Council, match functional positioning and clinical needs, have appropriate conditions and qualified personnel, and obtain an allocation license from the provincial‑level or higher health authority.Measures and catalogs for large medical equipment shall be formulated jointly by the health authority under the State Council and relevant departments and approved by the State Council.**Article 49** Reusable medical devices shall be processed in accordance with disinfection and management provisions.Single‑use medical devices shall not be reused; used devices shall be destroyed and recorded. The catalog of single‑use devices shall be formulated and adjusted jointly by the drug regulatory and health authorities under the State Council.Devices proven safely reusable after design, process, or disinfection improvements shall be removed from the single‑use catalog.**Article 50** Users shall inspect, test, calibrate, maintain, and service devices requiring regular care in accordance with instructions, record and analyze such activities to ensure proper condition. Archives shall be established for long‑life large devices, recording use, maintenance, transfer, and actual operating time. Records shall be retained for at least 5 years after the prescribed service life.**Article 51** Users shall properly preserve original documents of purchased Class III devices to ensure traceability.Information on large, implantable, and interventional devices shall be recorded in medical records.**Article 52** Users shall immediately stop using defective devices, notify registrants, filers, or quality agencies for repair; devices failing safety standards after repair shall not be reused.**Article 53** For in vitro diagnostic reagents with no domestic equivalent, qualified medical institutions may develop and use them internally under the guidance of licensed physicians. Specific measures shall be formulated jointly by the drug regulatory and health authorities under the State Council.**Article 54** Drug regulatory and health authorities shall supervise device quality and use behavior respectively in accordance with their duties.**Article 55** Operators and users shall not operate or use unregistered/unfiled, uncertified, expired, invalid, or obsolete medical devices.**Article 56** Transfer of used devices between users shall ensure safety and effectiveness; expired, invalid, obsolete, or unqualified devices shall not be transferred.**Article 57** Imported medical devices shall be registered or filed in accordance with Chapter II.Imported devices shall have Chinese instructions and labels complying with these Regulations and mandatory standards, indicating origin and contact information of the entrusted Chinese enterprise legal person. Devices without compliant Chinese documents shall not be imported.Small‑volume import of urgently needed Class II and Class III devices for clinical use may be approved by the drug regulatory department under the State Council or authorized provincial‑level people’s government, for use in designated institutions for specific purposes.Import of used, expired, invalid, or obsolete devices is prohibited.**Article 58** Entry‑exit inspection and quarantine institutions shall inspect imported medical devices; unqualified devices shall not be imported.The drug regulatory department under the State Council shall timely share registration and filing information with entry‑exit inspection and quarantine authorities. Local inspection and quarantine institutions shall timely share customs clearance information with municipal drug regulatory departments.**Article 59** Export enterprises shall ensure products comply with requirements of the importing country/region.**Article 60** Medical device advertisements shall be truthful, lawful, and based on registered or filed instructions, without false, exaggerated, or misleading content.Advertisements shall be reviewed and approved by provincial‑level advertising authorities before release; unapproved advertisements shall not be published.Advertisements for devices suspended from production, import, operation, or use are prohibited during suspension.Advertising review measures shall be formulated by the market regulatory department under the State Council.## Chapter V Adverse Event Management and Medical Device Recall**Article 61** The State establishes a medical device adverse event monitoring system for timely collection, analysis, evaluation, and control of adverse events.**Article 62** Registrants and filers shall establish monitoring systems with appropriate institutions and personnel, actively monitor products, and report investigation, analysis, evaluation, and risk control to technical agencies in accordance with regulations.Manufacturers, operators, and users shall assist monitoring; adverse events or suspected events shall be reported to technical agencies in accordance with regulations.Other units and individuals may report adverse events or suspected events to drug regulatory departments or technical agencies.**Article 63** The drug regulatory department under the State Council shall strengthen the monitoring information network.Technical agencies shall actively collect information, verify, investigate, analyze, and evaluate events, and propose handling suggestions to drug regulatory and health authorities.Contact information shall be publicized for reporting.**Article 64** Drug regulatory departments shall issue warnings and order suspension of production, import, operation, or use based on evaluation results.Provincial‑level or higher drug regulatory departments shall jointly investigate and handle sudden, mass serious injury or death events with health and relevant authorities, and strengthen monitoring of similar devices.Adverse event monitoring information shall be shared with health authorities.**Article 65** Registrants, filers, manufacturers, operators, and users shall cooperate with investigations by technical agencies, drug regulatory departments, and health authorities.**Article 66** Registrants and filers shall voluntarily conduct post‑market re‑evaluation in the following cases:1. Changed understanding of safety and effectiveness due to scientific progress;2. Monitoring indicating potential defects;3. Other cases stipulated by the drug regulatory department under the State Council.Control measures shall be taken, and registration or filing amended accordingly. Devices failing safety and effectiveness shall be voluntarily deregistered or filing canceled; otherwise, the authority shall revoke registration or cancel filing.Provincial‑level or higher drug regulatory departments may conduct re‑evaluation; unsafe devices shall be deregistered or filing canceled.Revocation or cancellation shall be publicized; affected devices shall not be produced, imported, operated, or used.**Article 67** Registrants and filers shall immediately stop production, notify operators, users, and consumers to stop use, recall marketed devices, take remedial or destruction measures, record and release information, and report recall and handling to drug regulatory and health authorities if products fail mandatory standards, technical requirements, or have other defects.Entrusted producers and operators shall stop production/operation, notify registrants/filers, and record such actions. Registrants/filers shall immediately recall devices requiring recall.The authority may order recall or suspension of production/operation if obligations are not fulfilled.## Chapter VI Supervision and Inspection**Article 68** The State establishes a professional and specialized inspector system to strengthen supervision and inspection.**Article 69** Drug regulatory departments shall strengthen supervision of R&D, production, operation, and use quality, focusing on:1. Compliance with registered or filed technical requirements in production;2. Effective operation of quality management systems;3. Sustained compliance of production and operation conditions with legal requirements.Extended inspections may be conducted on supporting units and individuals if necessary.**Article 70** Drug regulatory departments have the following powers during supervision:1. On‑site inspections and sampling;2. Accessing, copying, sealing, or detaining contracts, receipts, account books, and other materials;3. Sealing or detaining non‑compliant devices, parts, raw materials, tools, and equipment;4. Sealing premises engaged in illegal activities.Inspections shall be conducted with law enforcement certificates, and trade secrets protected.Units and individuals shall cooperate, provide documents, and shall not conceal, refuse, or obstruct inspections.**Article 71** Health authorities shall strengthen supervision of device use in medical institutions, accessing and copying records and materials.**Article 72** Drug regulatory departments may issue warnings, conduct oversight interviews, and order rectification for potential quality risks.Emergency suspension of production, import, operation, or use and safety warnings may be ordered for devices causing harm or posing proven risks.**Article 73** Drug regulatory departments shall conduct random inspections without fees, costs included in government budgets. Provincial‑level or higher departments shall release quality bulletins based on inspection results.Health authorities shall supervise and evaluate large medical equipment, correcting overuse and overtreatment.**Article 74** Leading officials of drug regulatory departments failing to detect systemic risks or eliminate hidden dangers shall be interviewed by the people’s government or higher authorities.Leading officials of local people’s governments failing to fulfill duties or eliminate regional major hidden dangers shall be interviewed by higher authorities.Interviewed departments and governments shall immediately rectify.**Article 75** Inspection institution accreditation shall be uniformly managed. Only institutions accredited jointly by the certification and accreditation regulatory department and drug regulatory department under the State Council may conduct inspections.Law enforcement inspections shall be entrusted to qualified institutions with payment.Parties objecting to inspection results may apply for re‑inspection within 7 working days; re‑inspection shall be conducted by a randomly selected different qualified institution, with final results. The re‑inspection institution roster shall be publicized.**Article 76** For devices with potential hazards or unauthorized changes that cannot be inspected by standard methods, inspection institutions may use supplementary items and methods approved by the drug regulatory department under the State Council; results may serve as regulatory basis.**Article 77** Market regulatory departments shall supervise medical device advertisements and investigate violations in accordance with advertising laws and administrative regulations.**Article 78** Drug regulatory departments shall timely publish licensing, filing, inspection, and penalty information via the online platform, protecting trade secrets.Credit files shall be established, with increased inspection frequency and disciplinary measures for bad credit records.**Article 79** Authorities shall publicize contact information for inquiries, complaints, and reports, timely replying and handling. Records shall be maintained.Whistleblowers providing verified information shall be rewarded and protected.**Article 80** Formulation, adjustment, and revision of catalogs and specifications shall solicit public opinions via hearings, appraisal meetings, etc., from experts, registrants, filers, manufacturers, operators, users, consumers, and industry associations.## Chapter VII Legal Liability**Article 81** Violations of the following shall result in confiscation of illegal gains, devices, tools, equipment, and raw materials; a fine of not less than 50,000 yuan nor more than 150,000 yuan if the value is less than 10,000 yuan, or 15 to 30 times the value if 10,000 yuan or more; serious violations shall result in production/operation suspension, 10‑year ban on licensing applications, confiscation of illegal income of responsible persons, a fine of 30% to 3 times such income, and lifetime ban from the industry:1. Production or operation of unregistered Class II or Class III devices;2. Unlicensed production of Class II or Class III devices;3. Unlicensed operation of Class III devices.Serious violations of Item 1 shall result in revocation of production or operation licenses.**Article 82** Unauthorized allocation of large medical equipment shall result in cessation of use, warning, confiscation of illegal gains; a fine of not less than 50,000 yuan nor more than 100,000 yuan if illegal gains are less than 10,000 yuan, or 10 to 30 times illegal gains if 10,000 yuan or more; serious violations shall result in 5‑year ban on allocation applications, confiscation of illegal income of responsible persons, a fine of 30% to 3 times such income, and disciplinary sanctions.**Article 83** Fraud in licensing applications shall result in rejection or revocation of licenses, confiscation of illegal gains and devices, 10‑year ban on licensing applications, fines as specified in Article 81, and lifetime ban for serious violations.Forging, altering, trading, leasing, or lending licenses shall result in confiscation or revocation, fines of not less than 50,000 yuan nor more than 100,000 yuan if illegal gains are less than 10,000 yuan, or 10 to 20 times illegal gains if 10,000 yuan or more; public security penalties if applicable.**Article 84** Violations of the following shall be publicized, ordered to rectify; failure to rectify shall result in confiscation of illegal gains and devices, fines of not less than 10,000 yuan nor more than 50,000 yuan if value is less than 10,000 yuan, or 5 to 20 times value if 10,000 yuan or more; serious violations shall result in confiscation of illegal income of responsible persons, a fine of 30% to 2 times such income, and 5‑year ban from the industry:1. Production or operation of unfiled Class I devices;2. Unfiled production of Class I devices;3. Unfiled operation of Class II devices requiring filing;4. Non‑compliant filing documents.**Article 85** Fraud in filing shall result in public announcement, confiscation of illegal gains and devices, fines of not less than 20,000 yuan nor more than 50,000 yuan if value is less than 10,000 yuan, or 5 to 20 times value if 10,000 yuan or more; serious violations shall result in production/operation suspension, confiscation of illegal income of responsible persons, a fine of 30% to 3 times such income, and 10‑year ban from the industry.**Article 86** Violations of the following shall result in correction, confiscation of illegal devices, fines of not less than 20,000 yuan nor more than 50,000 yuan if value is less than 10,000 yuan, or 5 to 20 times value if 10,000 yuan or more; serious violations shall result in production/operation suspension, revocation of certificates, confiscation of illegal income of responsible persons, a fine of 30% to 3 times such income, and 10‑year ban from the industry:1. Production, operation, or use of devices failing mandatory standards or technical requirements;2. Failure to establish or maintain an effective quality management system affecting safety and effectiveness;3. Operation or use of uncertified, expired, invalid, obsolete, or unregistered devices;4. Refusal to recall or stop production/import/operation after order;5. Entrusting unqualified producers or failing to supervise entrusted production;6. Import of used, expired, invalid, or obsolete devices.**Article 87** Operators and users fulfilling incoming inspection obligations, with sufficient proof of ignorance and truthful source disclosure, shall have non‑compliant devices seized and may be exempt from administrative penalties.**Article 88** Violations of the following shall result in correction, fines of not less than 10,000 yuan nor more than 50,000 yuan; refusal to rectify shall result in fines of not less than 50,000 yuan nor more than 100,000 yuan; serious violations shall result in production/operation suspension, revocation of licenses, confiscation of illegal income of responsible persons, a fine of 30% to 2 times such income, and 5‑year ban from the industry:1. Failure to rectify, suspend production, or report changed production conditions;2. Production or operation of devices with non‑compliant instructions or labels;3. Failure to transport or store devices in accordance with instructions and labels;4. Transfer of expired, invalid, obsolete, or unqualified used devices.**Article 89** Violations of the following shall result in correction and warning by drug regulatory and health authorities; refusal to rectify shall result in fines of not less than 10,000 yuan nor more than 100,000 yuan; serious violations shall result in production/operation suspension, revocation of certificates, and fines of not less than 10,000 yuan nor more than 30,000 yuan for responsible persons:1. Failure to submit quality management system self‑inspection reports;2. Purchasing devices from unqualified suppliers;3. Failure to establish or implement incoming inspection records;4. Failure to establish or implement sales records for wholesale Class II/III and retail Class III devices;5. Failure to conduct adverse event monitoring, report events, or cooperate with investigations;6. Failure to formulate or implement post‑market research and risk control plans;7. Failure to establish or implement traceability systems;8. Failure to report online sales information;9. Failure to inspect, test, calibrate, maintain, or record devices requiring regular care;10. Failure to properly preserve original documents of purchased Class III devices.**Article 90** Violations of the following shall result in correction and warning by health authorities; refusal to rectify shall result in fines of not less than 50,000 yuan nor more than 100,000 yuan; serious violations shall result in fines of not less than 100,000 yuan nor more than 300,000 yuan, suspension of use, revocation of practice licenses, suspension or revocation of practitioner certificates, confiscation of illegal income of responsible persons, a fine of 30% to 3 times such income, and disciplinary sanctions:1. Improper disinfection or handling of reusable devices;2. Reuse of single‑use devices or failure to destroy used single‑use devices;3. Failure to record large, implantable, or interventional device information in medical records;4. Failure to stop using defective devices or continuing to use unqualified repaired devices;5. Illegal use of large medical equipment endangering quality and safety.**Article 91** Violations of import inspection laws and administrative regulations shall be handled by entry‑exit inspection and quarantine institutions in accordance with the law.**Article 92** E‑commerce platforms failing to fulfill real‑name registration, review, reporting, or suspension obligations shall be penalized in accordance with the *E‑Commerce Law of the People’s Republic of China*.**Article 93** Unfiled clinical trial institutions shall be ordered to stop trials and correct; refusal to rectify shall invalidate trial data, result in fines of 50,000–100,000 yuan, and public announcement; serious consequences shall result in 5‑year ban and fines of 100,000–300,000 yuan, with penalties for responsible persons.Unfiled trial sponsors shall be ordered to stop trials, fined 50,000–100,000 yuan, and publicized; serious consequences shall result in fines of 100,000–300,000 yuan, invalid data, and 5‑year registration ban.Sponsors conducting unapproved high‑risk Class III trials shall be ordered to stop, fined 100,000–300,000 yuan, and publicized; serious consequences shall result in fines of 300,000–1,000,000 yuan, invalid data, 10‑year ban on trials and registration, and penalties for responsible persons.**Article 94** Trial institutions failing to comply with good clinical practice shall be ordered to correct or stop trials, fined 50,000–100,000 yuan; serious consequences shall result in 5‑year ban and penalties for responsible persons.**Article 95** Trial institutions issuing false reports shall be fined 100,000–300,000 yuan, illegal gains confiscated, 10‑year ban, with penalties for responsible persons.**Article 96** Inspection institutions issuing false reports shall have accreditation revoked, 10‑year ban on applications, fined 100,000–300,000 yuan, illegal gains confiscated, with penalties for responsible persons; dismissed personnel shall be banned from inspection work for 10 years.**Article 97** Violations of medical device advertising provisions shall be penalized in accordance with the *Advertising Law of the People’s Republic of China*.**Article 98** Chinese enterprise legal persons entrusted by overseas registrants/filers failing to fulfill obligations shall be ordered to correct, warned, fined 50,000–100,000 yuan; serious violations shall result in fines of 100,000–500,000 yuan and 5‑year ban for responsible persons.Overseas entities refusing to accept penalties shall be banned from import for 10 years.**Article 99** Entities hiring banned personnel shall be ordered to correct, warned; refusal to rectify shall result in production/operation suspension or license revocation.**Article 100** Technical evaluation and monitoring agencies failing duties causing major errors shall be ordered to correct, criticized, warned; serious consequences shall result in disciplinary sanctions for responsible persons.**Article 101** Regulatory staff abusing power, neglecting duties, or engaging in corruption shall be disciplined in accordance with the law.**Article 102** Violations constituting crimes shall be prosecuted for criminal liability; those causing personal or property damage shall bear compensation liability.## Chapter VIII Supplementary Provisions**Article 103** Definitions:- **Medical devices**: Instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including required computer software, whose primary functions are obtained through physical means (pharmacological, immunological, or metabolic means only assist), intended for: 1. Diagnosis, prevention, monitoring, treatment, or alleviation of diseases; 2. Diagnosis, monitoring, treatment, alleviation, or compensation for injuries; 3. Examination, replacement, regulation, or support of physiological structures or processes; 4. Life support or maintenance; 5. Pregnancy control; 6. Provision of medical or diagnostic information through testing human samples.- **Medical device registrant/filer**: An enterprise or R&D institution that has obtained a registration certificate or completed filing.- **Medical device user**: An institution providing medical services using medical devices, including medical institutions, family planning technical service institutions, blood stations, plasma stations, and assistive device adaptation institutions.- **Large medical equipment**: Large‑scale, technically complex, high‑investment, high‑operating‑cost devices included in the catalog.**Article 104** Fees may be charged for medical device registration; specific items and rates shall be formulated by the finance and pricing authorities under the State Council.**Article 105** Measures for medical devices developed by medical institutions to respond to public health emergencies shall be formulated jointly by the drug regulatory and health authorities under the State Council.Storage, allocation, and supply of non‑profit contraceptive medical devices shall comply with measures formulated jointly by the health and drug regulatory authorities under the State Council.Technical guidelines for traditional Chinese medicine medical devices shall be formulated jointly by the drug regulatory department under the State Council and the traditional Chinese medicine authority.**Article 106** Supervision and administration of military medical device use shall comply with these Regulations and relevant military provisions.**Article 107** These Regulations shall come into force on June 1, 2021.需要我把这份英文译文整理成**可直接提交的Word纯文本**，并统一专业术语格式吗？