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Regulations on the Supervision and Administration of Medical Devices
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Time：2021-03-19
Regulations on the Supervision and Administration of Medical Devices
Decree of the State Council of the People's Republic of China
No. 739
The
Premier Li Keqiang
February 9, 2021
Regulations on the Supervision and Administration of Medical Devices
(Promulgated by Decree No. 276 of the State Council of the People's Republic of China on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; revised according to the
Chapter I General Provisions
Article 1 These Regulations are formulated to ensure the safety and effectiveness of medical devices, safeguard human health and life safety, and promote the development of the medical device industry.
Article 2 These Regulations apply to activities involving the research and development, production, operation, and use of medical devices, as well as their supervision and administration, within the territory of the People's Republic of China.
Article 3 The drug regulatory department of the State Council is responsible for the supervision and administration of medical devices nationwide.
Relevant departments of the State Council are responsible for medical device-related supervision and administration within their respective scopes of responsibility.
Article 4 Local people's governments at or above the county level shall strengthen leadership over the supervision and administration of medical devices within their administrative areas, organize and coordinate medical device supervision and administration work and emergency response within their administrative areas, enhance medical device supervision and administration capabilities, and provide guarantees for medical device safety.
The drug regulatory departments of local people's governments at or above the county level are responsible for the supervision and administration of medical devices within their respective administrative areas. Relevant departments of local people's governments at or above the county level are responsible for medical device-related supervision and administration within their respective scopes of responsibility.
Article 5 The supervision and administration of medical devices shall follow the principles of risk management, full-process control, scientific regulation, and social co-governance.
Article 6 The state implements classified management of medical devices according to their risk levels.
Class I refers to medical devices with low risk, for which routine management can ensure their safety and effectiveness.
Class II refers to medical devices with moderate risk, requiring strict control and management to ensure their safety and effectiveness.
Class III refers to medical devices with high risk, requiring special measures and strict control and management to ensure their safety and effectiveness.
When evaluating the risk level of a medical device, factors such as its intended purpose, structural characteristics, and method of use should be considered.
The drug regulatory department of the State Council is responsible for formulating medical device classification rules and catalogs, and shall, based on the production, operation, and use of medical devices, promptly analyze and evaluate changes in medical device risks, and adjust the classification rules and catalogs. When formulating or adjusting classification rules and catalogs, opinions from medical device registrants, record-filers, production and operation enterprises, as well as user units and industry organizations, shall be fully solicited, and international medical device classification practices shall be referenced. Medical device classification rules and catalogs shall be announced to the public.
Article 7 Medical device products shall comply with mandatory national standards for medical devices; if there are no mandatory national standards, they shall comply with mandatory industry standards for medical devices.
Article 8 The state formulates medical device industry plans and policies, incorporates medical device innovation into development priorities, grants priority review and approval to innovative medical devices, supports the clinical promotion and use of innovative medical devices, and promotes the high-quality development of the medical device industry. The drug regulatory department of the State Council shall cooperate with relevant departments of the State Council in implementing national medical device industry plans and guiding policies.
Article 9 The state improves the medical device innovation system, supports basic and applied research of medical devices, promotes the popularization and application of new medical device technologies, and provides support in areas such as scientific project establishment, financing, credit, bidding and procurement, and medical insurance. It supports enterprises in establishing or jointly forming R&D institutions, encourages enterprises to cooperate with universities, research institutes, medical institutions, etc., in medical device research and innovation, strengthens medical device intellectual property protection, and enhances the independent innovation capability of medical devices.
Article 10 The state strengthens the informatization construction of medical device supervision and administration, improves the level of online government services, and provides convenience for medical device administrative licensing, record-filing, and other related matters.
Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credit system, urge enterprises to carry out production and business activities in accordance with the law, and guide enterprises to operate with integrity.
Article 12 Units and individuals who have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations.
Chapter II Medical Device Product Registration and Record-filing
Article 13 Class I medical devices are subject to product record-filing management, while Class II and Class III medical devices are subject to product registration management.
Medical device registrants and record-filers shall strengthen quality management throughout the entire life cycle of medical devices and bear legal responsibility for the safety and effectiveness of medical devices throughout the research and development, production, operation, and use processes.
Article 14 For record-filing of Class I medical device products and applying for registration of Class II and Class III medical device products, the following materials shall be submitted:
(1) Product risk analysis data;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product instructions and label drafts;
(6) Quality management system documents related to product research, development, and production;
(7) Other materials required to prove product safety and effectiveness.
The product inspection report shall comply with the requirements of the drug regulatory department of the State Council and can be a self-inspection report from the medical device registration applicant or record-filer, or an inspection report issued by a qualified medical device inspection institution.
If the conditions for exemption from clinical evaluation stipulated in Article 24 of these Regulations are met, clinical evaluation data may be exempted from submission.
Medical device registration applicants and record-filers shall ensure that the submitted materials are lawful, truthful, accurate, complete, and traceable.
Article 15 For the record-filing of Class I medical device products, the record-filer shall submit the record-filing materials to the drug regulatory department of the municipal people's government with districts where it is located.
For overseas record-filers exporting Class I medical devices to China, their designated enterprise legal person within China shall submit record-filing materials and proof documents from the competent authority of the record-filer's country (region) allowing the medical device to be marketed. For innovative medical devices not yet marketed overseas, the proof document from the competent authority of the record-filers' country (region) allowing the medical device to be marketed may not be submitted.
The record-keeping is complete once the registrant submits the record-keeping materials that comply with the provisions of these Regulations to the department responsible for drug supervision and administration. The department responsible for drug supervision and administration shall, within 5 working days from the date of receiving the record-keeping materials, publicly disclose relevant record-keeping information through the online government service platform of the State Council's drug supervision and administration department.
If there are changes in the matters specified in the record-keeping materials, the registrant shall apply for a change of record-keeping with the original record-keeping department.
Article 16 To apply for registration of Class II medical device products, the registration applicant shall submit registration application materials to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for registration of Class III medical device products, the registration applicant shall submit registration application materials to the State Council's drug supervision and administration department.
For overseas registration applicants exporting Class II and Class III medical devices to China, their designated Chinese enterprise legal person shall submit registration application materials and proof of market authorization for the medical device from the competent authority of the applicant's country (region) to the State Council's drug supervision and administration department. Innovative medical devices not yet marketed overseas may be exempt from submitting proof of market authorization from the competent authority of the applicant's country (region).
The State Council's drug supervision and administration department shall formulate provisions on the procedures and requirements for medical device registration review, and strengthen supervision and guidance over the registration review work of the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.
Article 17 The drug supervision and administration department accepting the registration application shall review the safety and effectiveness of the medical device, as well as the registration applicant's quality management capabilities to ensure the safety and effectiveness of the medical device.
The drug supervision and administration department accepting the registration application shall transfer the registration application materials to the technical review institution within 3 working days from the date of accepting the registration application. After completing the technical review, the technical review institution shall submit its review opinions to the drug supervision and administration department accepting the registration application as a basis for approval.
If the drug supervision and administration department accepting the registration application deems it necessary to conduct a quality management system inspection during the technical review of the medical device, it shall organize and carry out the quality management system inspection.
Article 18 The drug supervision and administration department accepting the registration application shall make a decision within 20 working days from the date of receiving the review opinions. If the conditions are met, registration shall be approved and a medical device registration certificate issued; if the conditions are not met, registration shall be denied and the reasons shall be explained in writing.
The drug supervision and administration department accepting the registration application shall, within 5 working days from the date of approval of the medical device registration, publicly disclose relevant registration information through the online government service platform of the State Council's drug supervision and administration department.
Article 19 For medical devices urgently needed for treating rare diseases, life-threatening diseases for which there are no effective treatment methods, and for responding to public health emergencies, the drug supervision and administration department accepting the registration application may make a conditional approval decision and specify relevant matters in the medical device registration certificate.
In the event of an extraordinarily major public health emergency or other emergency that seriously threatens public health, if the State Council's health administration department proposes emergency use of medical devices based on the needs of prevention and control, such devices may be used urgently within a certain scope and period after deliberation and approval by the State Council's drug supervision and administration department.
Article 20 Medical device registrants and record-keepers shall fulfill the following obligations:
(1) Establish and maintain an effectively operating quality management system adapted to the product;
(2) Formulate post-market research and risk control plans and ensure their effective implementation;
(3) Conduct adverse event monitoring and re-evaluation in accordance with the law;
(4) Establish and implement product traceability and recall systems;
(5) Other obligations stipulated by the State Council's drug supervision and administration department.
The Chinese enterprise legal person designated by an overseas medical device registrant or record-keeper shall assist the registrant or record-keeper in fulfilling the obligations specified in the preceding paragraph.
Article 21 For registered Class II and Class III medical device products, if there are substantive changes in design, raw materials, production process, scope of application, or method of use that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for change registration procedures; for other changes, they shall file a record or report in accordance with the provisions of the State Council's drug supervision and administration department.
Article 22 The validity period of a medical device registration certificate is 5 years. If registration renewal is required upon expiry, an application for renewal shall be submitted to the original registration department 6 months prior to the expiry date.
Unless there are circumstances specified in the third paragraph of this Article, the drug supervision and administration department receiving the renewal application shall make a decision to approve the renewal before the expiry date of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed as approved for renewal.
In any of the following circumstances, registration shall not be renewed:
(1) Failure to submit a renewal application within the specified period;
(2) Mandatory standards for medical devices have been revised, and the medical device applying for renewal cannot meet the new requirements;
(3) For conditionally approved medical devices, the matters specified in the medical device registration certificate have not been completed within the prescribed period.
Article 23 For newly developed medical devices not yet included in the classification catalogue, applicants may either directly apply for product registration in accordance with the provisions of these Regulations concerning Class III medical device product registration, or determine the product category based on classification rules and apply to the State Council's drug supervision and administration department for category confirmation, and then apply for product registration or conduct product record-keeping in accordance with the provisions of these Regulations.
If directly applying for Class III medical device product registration, the State Council's drug supervision and administration department shall determine the category based on the degree of risk and promptly include approved medical devices in the classification catalogue. If applying for category confirmation, the State Council's drug supervision and administration department shall determine the category of the medical device and inform the applicant within 20 working days from the date of accepting the application.
Article 24 Clinical evaluation shall be conducted for medical device product registration and record-keeping; however, clinical evaluation may be exempted if one of the following conditions is met:
(1) The working mechanism is clear, the design is finalized, the production process is mature, similar medical devices already on the market have been in clinical use for many years without records of serious adverse events, and the conventional use is not changed;
(2) Other non-clinical evaluations can prove the medical device's safety and effectiveness.
The State Council's drug supervision and administration department shall formulate guidelines for medical device clinical evaluation.
Article 25 When conducting medical device clinical evaluation, based on product characteristics, clinical risks, existing clinical data, etc., the safety and effectiveness of the medical device can be proven through conducting clinical trials, or by analyzing and evaluating clinical literature and data of similar medical devices.
In accordance with the regulations of the State Council's drug supervision and administration department, if existing clinical literature and data are insufficient to confirm the safety and effectiveness of a medical device during clinical evaluation, a clinical trial shall be conducted.
Article 26: The conduct of medical device clinical trials shall be in accordance with the requirements of the Good Clinical Practice for Medical Device Clinical Trials, conducted in clinical trial institutions with the corresponding conditions, and filed with the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government where the clinical trial applicant is located. The drug supervision and administration department that accepts the filing of clinical trials shall inform the drug supervision and administration department and health authority at the same level where the clinical trial institution is located of the filing situation.
Medical device clinical trial institutions are subject to filing management. The conditions that medical device clinical trial institutions should meet, as well as the filing management methods and good clinical practice for clinical trials, shall be formulated and promulgated by the State Council's drug supervision and administration department in conjunction with the State Council's health authority.
The state supports medical institutions in conducting clinical trials, incorporates the evaluation of clinical trial conditions and capabilities into the grading evaluation of medical institutions, and encourages medical institutions to conduct clinical trials of innovative medical devices.
Article 27: Clinical trials of Class III medical devices that pose a high risk to the human body shall be approved by the State Council's drug supervision and administration department. When approving clinical trials, the State Council's drug supervision and administration department shall conduct a comprehensive analysis of the conditions of the institutions undertaking the medical device clinical trials, such as equipment and professional personnel; the risk level of the medical device; the clinical trial implementation plan; and the clinical benefit-risk comparison analysis report, and shall make a decision and notify the clinical trial applicant within 60 working days from the date of acceptance of the application. If no notification is given within the time limit, it shall be deemed as consent. If the clinical trial is approved, the drug supervision and administration department and health authority of the provincial, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located shall be informed.
The catalog of Class III medical devices whose clinical trials pose a high risk to the human body shall be formulated, adjusted, and promulgated by the State Council's drug supervision and administration department.
Article 28: The conduct of medical device clinical trials shall be subject to ethical review as prescribed by law; the purpose, use, and potential risks of the trial shall be explained in detail to the subjects, and their written informed consent shall be obtained; if the subject is a person without civil capacity or a person with limited civil capacity, the written informed consent of his or her guardian shall be obtained in accordance with the law.
In conducting clinical trials, no fees related to the clinical trial shall be charged to the subjects in any form.
Article 29: For medical devices currently undergoing clinical trials for the treatment of serious life-threatening diseases for which there are no effective treatment methods, if medical observation may benefit the patient, after ethical review and informed consent, they may be used free of charge for other patients with the same condition within the institutions conducting the medical device clinical trials; the safety data may be used for medical device registration applications.
Chapter 3: Medical Device Production
Article 30: Those engaged in medical device production activities shall meet the following conditions:
(1) Have production sites, environmental conditions, production equipment, and professional and technical personnel that are suitable for the medical devices produced;
(2) Have an institution or full-time inspection personnel and inspection equipment that can conduct quality inspection of the medical devices produced;
(3) Have a management system to ensure the quality of medical devices;
(4) Have after-sales service capabilities that are suitable for the medical devices produced;
(5) Meet the requirements of the product research and development and production process documents.
Article 31: Those engaged in the production of Class I medical devices shall file with the department responsible for drug supervision and administration of the municipal government at the county level where they are located. The filing shall be completed after submitting relevant materials that meet the conditions stipulated in Article 30 of these Regulations.
If a medical device filer produces Class I medical devices on its own, it may submit relevant materials that meet the conditions stipulated in Article 30 of these Regulations together with the product filing in accordance with the provisions of Article 15 of these Regulations, thus completing the production filing.
Article 32: Those engaged in the production of Class II and Class III medical devices shall apply to the drug supervision and administration department of the provincial, autonomous region, or municipality directly under the Central Government where they are located for a production license and submit relevant materials that meet the conditions stipulated in Article 30 of these Regulations, as well as the registration certificate for the medical devices produced.
The drug supervision and administration department that accepts the application for a production license shall review the application materials, conduct verification in accordance with the requirements of the Good Manufacturing Practice for Medical Devices formulated by the State Council's drug supervision and administration department, and make a decision within 20 working days from the date of acceptance of the application. For those that meet the prescribed conditions, a license shall be granted and a medical device production license shall be issued; for those that do not meet the prescribed conditions, the license shall not be granted, and the reasons shall be stated in writing.
The medical device production license is valid for 5 years. If it is necessary to renew the license upon expiry, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative licenses.
Article 33: The Good Manufacturing Practice for Medical Devices shall make clear provisions on matters that affect the safety and effectiveness of medical devices, such as the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, enterprise organizational structure and personnel allocation.
Article 34: Medical device registrants and filers may produce medical devices themselves, or they may entrust enterprises that meet the provisions of these Regulations and have the corresponding conditions to produce medical devices.
For entrusted production of medical devices, the medical device registrant or filer shall be responsible for the quality of the medical devices entrusted for production, and shall strengthen the management of the production behavior of the entrusted production enterprise to ensure that it produces in accordance with legal requirements. The medical device registrant or filer shall sign an entrustment agreement with the entrusted production enterprise, clarifying the rights, obligations, and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws, regulations, Good Manufacturing Practice for Medical Devices, mandatory standards, product technical requirements, and entrustment agreements, be responsible for its production behavior, and accept supervision from the entrusting party.
High-risk implantable medical devices shall not be entrusted for production. The specific catalog shall be formulated, adjusted, and promulgated by the State Council's drug supervision and administration department.
Article 35: Medical device registrants, filers, and entrusted production enterprises shall establish and improve a quality management system suitable for the medical devices produced in accordance with the Good Manufacturing Practice for Medical Devices, and ensure its effective operation; strictly organize production in accordance with the product technical requirements registered or filed, and ensure that the medical devices leaving the factory meet the mandatory standards and the product technical requirements registered or filed.
Medical device registrants, filers, and entrusted production enterprises shall regularly conduct self-inspections of the operation of the quality management system, and submit self-inspection reports in accordance with the provisions of the State Council's drug supervision and administration department.
Article 36: If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the medical device registrant, filer, or entrusted production enterprise shall immediately take corrective measures; if it may affect the safety and effectiveness of the medical devices, production activities shall be immediately stopped, and the original production license or production filing department shall be reported.
Article 37: Medical devices shall use generic names. Generic names shall comply with the medical device naming rules formulated by the State Council's drug supervision and administration department.
Article 38: The state shall implement the unique identification system for medical devices in stages according to the product categories of medical devices, to achieve traceability of medical devices. The specific methods shall be formulated by the State Council's drug supervision and administration department in conjunction with the relevant departments of the State Council.
Article 39 Medical devices shall have instructions and labels. The content of the instructions and labels shall be consistent with the registered or filed information, ensuring authenticity and accuracy.
The instructions and labels of medical devices shall indicate the following:
(1) Generic name, model, and specifications;
(2) Name, address, and contact information of the medical device registrant, filer, and entrusted manufacturer;
(3) Production date, period of use, or expiry date;
(4) Product performance, main structure, and scope of application;
(5) Contraindications, precautions, and other contents requiring warnings or reminders;
(6) Installation and use instructions or illustrations;
(7) Maintenance and upkeep methods, special transportation and storage conditions, and methods;
(8) Other contents that should be indicated according to the product technical requirements.
Class II and Class III medical devices shall also indicate the medical device registration certificate number.
Medical devices used personally by consumers shall also have special instructions for safe use.
Chapter 4 Operation and Use of Medical Devices
Article 40 Engaging in medical device business activities shall require business premises and storage conditions commensurate with the business scale and scope, as well as quality management systems and quality management organizations or personnel suitable for the medical devices being operated.
Article 41 For operating Class II medical devices, the operating enterprise shall file with the drug regulatory department of the people's government at the municipal level where it is located and submit relevant documents that meet the conditions stipulated in Article 40 of these Regulations.
According to the regulations of the drug regulatory department of the State Council, Class II medical devices whose safety and effectiveness are not affected by the circulation process may be exempt from business filing.
Article 42 For operating Class III medical devices, the operating enterprise shall apply for an operating license with the drug regulatory department of the people's government at the municipal level where it is located and submit relevant documents that meet the conditions stipulated in Article 40 of these Regulations.
The drug regulatory department that accepts operating license applications shall review the application materials, organize verification when necessary, and make a decision within 20 working days from the date of acceptance. For those that meet the prescribed conditions, a license shall be granted and a medical device operating license issued; for those that do not meet the prescribed conditions, the license shall be denied and the reasons shall be stated in writing.
The medical device operating license is valid for 5 years. If an extension is required upon expiry, the extension procedures shall be handled in accordance with the relevant administrative licensing laws.
Article 43 Medical device registrants and filers operating their registered or filed medical devices are not required to obtain a medical device operating license or filing, but shall comply with the operating conditions stipulated in these Regulations.
Article 44 Engaging in medical device business shall establish and improve a quality management system appropriate for the medical devices being operated and ensure its effective operation, in accordance with laws, regulations, and the requirements of the Good Practice for Medical Device Operation formulated by the drug regulatory department of the State Council.
Article 45 Medical device operating enterprises and user units shall purchase medical devices from medical device registrants, filers, or manufacturing and operating enterprises with legal qualifications. When purchasing medical devices, they shall verify the supplier's qualifications and the conformity documents of the medical devices, and establish an inspection record system for incoming goods. Operating enterprises engaged in wholesale business of Class II and Class III medical devices, and retail business of Class III medical devices, shall also establish a sales record system.
Record items include:
(1) Name, model, specifications, and quantity of the medical device;
(2) Production batch number, period of use or expiry date, and sales date of the medical device;
(3) Name of the medical device registrant, filer, and entrusted manufacturer;
(4) Name, address, and contact information of the supplier or purchaser;
(5) Numbers of relevant license documents, etc.
Incoming inspection records and sales records shall be true, accurate, complete, and traceable, and shall be kept for the period specified by the drug regulatory department of the State Council. The state encourages the use of advanced technological means for record-keeping.
Article 46 Engaging in online sales of medical devices shall be carried out by medical device registrants, filers, or medical device operating enterprises. Operators engaged in online sales of medical devices shall inform the drug regulatory department of the people's government at the municipal level where they are located of relevant information regarding their online sales activities, except for operating Class I medical devices and Class II medical devices stipulated in the second paragraph of Article 41 of these Regulations.
E-commerce platform operators providing services for online medical device transactions shall conduct real-name registration for online medical device operators, review their operating licenses, filing status, and the registration and filing status of the medical devices they operate, and manage their operating behaviors. If e-commerce platform operators find that online medical device operators violate the provisions of these Regulations, they shall promptly stop such acts and immediately report to the drug regulatory department of the people's government at the municipal level where the medical device operator is located; if serious violations are found, they shall immediately cease providing online transaction platform services.
Article 47 The transportation and storage of medical devices shall comply with the requirements indicated in the medical device instructions and labels; for those with special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of the medical devices.
Article 48 Medical device user units shall have storage places and conditions commensurate with the types and quantities of medical devices in use. Medical device user units shall strengthen technical training for their staff and use medical devices in accordance with product instructions, technical operation specifications, and other requirements.
Medical device user units configuring large medical equipment shall comply with the large medical equipment configuration plan formulated by the health administrative department of the State Council, be commensurate with their functional positioning and clinical service needs, possess corresponding technical conditions, supporting facilities, and qualified and capable professional technical personnel, and obtain a large medical equipment configuration license approved by the health administrative department of the people's government at or above the provincial level.
The administrative measures for the configuration of large medical equipment shall be formulated by the health administrative department of the State Council in conjunction with relevant departments of the State Council. The catalog of large medical equipment shall be proposed by the health administrative department of the State Council in consultation with relevant departments of the State Council, and implemented after approval by the State Council.
Article 49 Medical device user units shall handle reusable medical devices in accordance with the disinfection and management regulations formulated by the health administrative department of the State Council.
Single-use medical devices must not be reused, and used devices should be destroyed and recorded in accordance with relevant national regulations. The catalogue of single-use medical devices shall be formulated, adjusted and announced by the State Drug Administration in conjunction with the State Health Authority. Inclusion in the catalogue of single-use medical devices should have sufficient evidence to support the inability to reuse. Reusable medical devices that can ensure safety and effectiveness are not included in the catalogue of single-use medical devices. For medical devices that can ensure safety and effectiveness after improvements in design, production processes, disinfection and sterilization techniques, etc., they should be adjusted out of the catalogue of single-use medical devices and allowed for reuse.
Article 50 Medical device users shall inspect, test, calibrate, maintain and service medical devices that require regular inspection, testing, calibration, maintenance and servicing in accordance with the product instructions, keep records, conduct timely analysis and evaluation to ensure that the medical devices are in good condition and guarantee the quality of use; for large medical devices with a long service life, a usage file should be established for each device, recording its use, maintenance, transfer, actual usage time, etc. The retention period of records shall not be less than 5 years after the end of the specified service life of the medical device.
Article 51 Medical device users shall properly preserve the original data of purchased Class III medical devices and ensure that the information is traceable.
When using large medical devices and implantable and interventional medical devices, the name, key technical parameters and other necessary information closely related to the quality and safety of use should be recorded in the medical records and other relevant records.
Article 52 If any safety hazard is found in the medical devices used, the medical device user shall immediately stop using them and notify the medical device registrant, filer or other institution responsible for product quality for repair; medical devices that still cannot meet the safety standards after repair shall not be used.
Article 53 For in-vitro diagnostic reagents for which there are no similar products on the domestic market, qualified medical institutions may develop them independently based on the clinical needs of their units and use them within their units under the guidance of practicing physicians. Specific management measures shall be formulated by the State Drug Administration in conjunction with the State Health Authority.
Article 54 The departments responsible for drug supervision and management and the health authorities shall, in accordance with their respective responsibilities, supervise and manage the quality of medical devices and the use of medical devices at the use stage.
Article 55 Medical device businesses and users shall not operate or use medical devices that have not been legally registered or filed, have no qualified certificates, or are expired, invalid, or obsolete.
Article 56 When medical device users transfer used medical devices to each other, the transferor shall ensure that the transferred medical devices are safe and effective, and shall not transfer expired, invalid, obsolete, or unqualified medical devices.
Article 57 Imported medical devices shall be medical devices that have been registered or filed in accordance with the provisions of Chapter II of these Regulations.
Imported medical devices shall have Chinese instructions and Chinese labels. The instructions and labels shall comply with the provisions of these Regulations and relevant mandatory standards, and shall specify the place of origin of the medical device and the name, address and contact information of the legal person of the enterprise in China designated by the overseas medical device registrant or filer. Those without Chinese instructions, Chinese labels, or whose instructions and labels do not comply with the provisions of these Regulations shall not be imported.
If a medical institution needs to import a small amount of Class II or Class III medical devices due to urgent clinical needs, it may import them after approval by the State Drug Administration or the provincial, autonomous regional, or municipal people's government authorized by the State Council. Imported medical devices shall be used for specific medical purposes within designated medical institutions.
It is prohibited to import expired, invalid, obsolete, or used medical devices.
Article 58 Entry-exit inspection and quarantine institutions shall conduct inspections of imported medical devices in accordance with the law; those that fail the inspection shall not be imported.
The State Drug Administration shall promptly inform the national entry-exit inspection and quarantine department of the registration and filing of imported medical devices. The entry-exit inspection and quarantine institution at the port of entry shall promptly inform the department responsible for drug supervision and management of the municipal people's government where it is located of the customs clearance of imported medical devices.
Article 59 Enterprises exporting medical devices shall ensure that their exported medical devices meet the requirements of the importing country (region).
Article 60 The content of medical device advertisements shall be true and legal, based on the instructions for medical devices registered or filed by the department responsible for drug supervision and management, and shall not contain false, exaggerated, or misleading content.
Before releasing medical device advertisements, the advertisement content shall be reviewed by the advertisement review agency determined by the people's government of the province, autonomous region, or municipality directly under the Central Government, and obtain the approval number for medical device advertisements; advertisements shall not be released without review.
Provincial-level and above people's governments' drug supervision and management departments order the suspension of production, import, operation and use of medical devices, and no advertisements involving the medical devices shall be released during the suspension period.
The review methods for medical device advertisements shall be formulated by the State Market Supervision and Administration Department.
Chapter 5 Handling of Adverse Events and Recall of Medical Devices
Article 61 The state shall establish a medical device adverse event monitoring system to promptly collect, analyze, evaluate and control medical device adverse events.
Article 62 Registrants and filers of medical devices shall establish a medical device adverse event monitoring system, equip it with monitoring institutions and personnel suitable for their products, actively monitor adverse events for their products, and report the investigation, analysis, evaluation, product risk control and other situations to the medical device adverse event monitoring technical institution in accordance with the regulations of the State Drug Administration.
Medical device manufacturers and operators and users shall assist the registrants and filers of medical devices in monitoring adverse events for the medical devices they produce, operate or use; if they find medical device adverse events or suspected adverse events, they shall report them to the medical device adverse event monitoring technical institution in accordance with the regulations of the State Drug Administration.
Other units and individuals who find medical device adverse events or suspected adverse events have the right to report them to the department responsible for drug supervision and management or the medical device adverse event monitoring technical institution.
Article 63 The State Drug Administration shall strengthen the construction of the medical device adverse event monitoring information network.
The medical device adverse event monitoring technical institution shall strengthen the monitoring of medical device adverse event information and actively collect adverse event information; if it finds adverse events or receives reports of adverse events, it shall promptly verify them, conduct investigations, analyses and evaluations if necessary, and report them to the department responsible for drug supervision and management and the health authorities and propose handling suggestions.
The medical device adverse event monitoring technical institution shall publish its contact information to facilitate the reporting of medical device adverse events by medical device registrants, filers, manufacturers, operators and users.
Article 64: The department responsible for drug supervision and administration shall, based on the assessment results of medical device adverse events, promptly take control measures such as issuing warning information and ordering the suspension of production, import, operation, and use.
The drug supervision and administration departments of people's governments at or above the provincial level shall, in conjunction with the health authorities and relevant departments at the same level, promptly investigate and handle medical device adverse events that cause sudden, mass serious injuries or deaths, and organize enhanced monitoring of similar medical devices.
The department responsible for drug supervision and administration shall promptly inform the health authorities at the same level of the relevant situation regarding the monitoring of adverse events from medical device using units.
Article 65: Medical device registrants, filers, production and operation enterprises, and using units shall cooperate with the medical device adverse event monitoring technical institutions, the department responsible for drug supervision and administration, and the health authorities in the investigation of medical device adverse events.
Article 66: Under any of the following circumstances, the medical device registrant or filer shall proactively conduct a re-evaluation of the already marketed medical device:
(1) Changes in understanding of the safety and effectiveness of medical devices based on the development of scientific research;
(2) Monitoring and assessment results of medical device adverse events indicate that the medical device may have defects;
(3) Other circumstances stipulated by the State Council's drug supervision and administration department.
The medical device registrant or filer shall, based on the re-evaluation results, take corresponding control measures, improve the already marketed medical device, and conduct registration changes or filing changes as per regulations. If the re-evaluation results show that the already marketed medical device cannot guarantee safety and effectiveness, the medical device registrant or filer shall proactively apply for the cancellation of the medical device registration certificate or the cancellation of the filing; if the medical device registrant or filer fails to apply for the cancellation of the medical device registration certificate or the cancellation of the filing, the department responsible for drug supervision and administration shall cancel the medical device registration certificate or the filing.
The drug supervision and administration departments of people's governments at or above the provincial level shall conduct re-evaluations of already marketed medical devices based on the monitoring and assessment of medical device adverse events. If the re-evaluation results show that the already marketed medical device cannot guarantee safety and effectiveness, the medical device registration certificate shall be cancelled or the filing shall be revoked.
The department responsible for drug supervision and administration shall promptly publicize to the public the cancellation of medical device registration certificates and the revocation of filings. Medical devices whose registration certificates have been cancelled or whose filings have been revoked shall not continue to be produced, imported, operated, or used.
Article 67: If a medical device registrant or filer discovers that the produced medical devices do not meet the mandatory standards, the product technical requirements as registered or filed, or have other defects, they shall immediately stop production, notify relevant operating enterprises, using units, and consumers to stop operation and use, recall already marketed medical devices, take remedial and disposal measures, record the relevant situation, release relevant information, and report the medical device recall and handling situation to the department responsible for drug supervision and administration and the health authorities.
If a medical device entrusted production enterprise or operating enterprise discovers that the produced or operated medical devices have the circumstances stipulated in the preceding paragraph, they shall immediately stop production and operation, notify the medical device registrant or filer, and record the situation of stopping production and operation and notification. If the medical device registrant or filer believes that the medical device needs to be recalled in accordance with the provisions of the preceding paragraph, they shall immediately recall it.
If the medical device registrant, filer, entrusted production enterprise, or operating enterprise fails to implement the recall or stop production and operation as per the provisions of this article, the department responsible for drug supervision and administration may order them to recall or stop production and operation.
Chapter 6: Supervision and Inspection
Article 68: The state shall establish a professionalized inspector system to strengthen the supervision and inspection of medical devices.
Article 69: The department responsible for drug supervision and administration shall strengthen the supervision and inspection of the quality of medical devices in the research, production, operation, and use stages, and shall conduct key supervision and inspection of the following matters:
(1) Whether production is organized in accordance with the registered or filed product technical requirements;
(2) Whether the quality management system maintains effective operation;
(3) Whether the production and operation conditions continuously meet the legal requirements.
If necessary, the department responsible for drug supervision and administration may conduct extended inspections of other relevant units and individuals that provide products or services for the research, production, operation, and use of medical devices.
Article 70: The department responsible for drug supervision and administration has the following powers in supervision and inspection:
(1) Enter the site to conduct inspections and collect samples;
(2) Review, copy, seal up, and seize relevant contracts, vouchers, account books, and other relevant materials;
(3) Seal up and seize medical devices that do not meet legal requirements, illegally used parts, raw materials, and tools and equipment used for the illegal production and operation of medical devices;
(4) Seal up venues engaged in the production and operation of medical devices in violation of this regulation.
When conducting supervision and inspection, law enforcement credentials shall be presented, and the commercial secrets of the inspected unit shall be kept confidential.
Relevant units and individuals shall cooperate with the supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse, or obstruct.
Article 71: The health authorities shall strengthen the supervision and inspection of the use of medical devices by medical institutions. When conducting supervision and inspection, they may enter medical institutions and review and copy relevant files, records, and other relevant materials.
Article 72: If there are product quality and safety hazards in the production and operation of medical devices and measures are not taken in a timely manner to eliminate them, the department responsible for drug supervision and administration may take measures such as admonition, accountability talks, and orders to rectify within a time limit.
For medical devices that cause harm to the human body or have evidence that may endanger human health, the department responsible for drug supervision and administration may take emergency control measures such as ordering the suspension of production, import, operation, and use, and issue safety warning information.
Article 73: The department responsible for drug supervision and administration shall strengthen the spot-check inspection of medical devices produced, operated, and used by medical device registrants, filers, production and operation enterprises, and using units. Spot-check inspections shall not charge inspection fees or any other fees; the required expenses shall be included in the local government budget. The drug supervision and administration departments of people's governments at or above the provincial level shall promptly issue announcements on medical device quality based on the conclusions of spot-check inspections.
The health authorities shall supervise and evaluate the use of large medical equipment; if they find illegal use and situations such as excessive examinations and excessive treatment related to large medical equipment, they shall immediately correct them and deal with them according to law.
Article 74: If the department responsible for drug supervision and administration fails to promptly discover systemic safety risks of medical devices or fails to promptly eliminate medical device safety hazards within the area under its supervision, the local people's government or the drug supervision and administration department of the higher-level people's government shall conduct accountability talks with its principal person in charge.
If a local people's government fails to fulfill its responsibilities regarding medical device safety and fails to eliminate major regional medical device safety hazards in a timely manner, the higher-level people's government or the department of the higher-level people's government responsible for drug supervision and administration shall conduct a meeting with its principal person in charge.
The departments and local people's governments that have been interviewed shall immediately take measures to rectify their medical device supervision and management work.
Article 75 The qualification accreditation work for medical device testing institutions shall be managed uniformly in accordance with relevant national regulations. Only testing institutions accredited by the State Council's certification and accreditation supervision and management department in conjunction with the State Council's drug supervision and administration department may conduct testing of medical devices.
When the department responsible for drug supervision and administration needs to test medical devices in law enforcement work, it shall entrust qualified medical device testing institutions to conduct the testing and pay the relevant fees.
If the party concerned has objections to the testing conclusion, it may, within 7 working days from the date of receipt of the testing conclusion, submit a retesting application to the department that conducted the sampling test or its superior department responsible for drug supervision and administration. The department that accepts the retesting application shall randomly select a retesting institution from the list of retesting institutions to conduct the retesting. The medical device testing institution undertaking the retesting work shall make a retesting conclusion within the time limit stipulated by the State Council's drug supervision and administration department. The retesting conclusion shall be the final testing conclusion. The retesting institution and the initial testing institution shall not be the same institution; if there is only one qualified testing institution for the relevant testing items, the undertaking department or personnel shall be changed during the retesting. The list of retesting institutions shall be published by the State Council's drug supervision and administration department.
Article 76 For medical devices that may contain harmful substances or that have arbitrarily changed the design, raw materials, and production processes of medical devices and have safety hazards, and which cannot be tested using the testing items and methods stipulated in the national and industry standards for medical devices, the medical device testing institution may use supplementary testing items and methods approved by the State Council's drug supervision and administration department for testing; the testing conclusions obtained using supplementary testing items and methods may be used as the basis for the department responsible for drug supervision and administration to determine the quality of medical devices.
Article 77 The market supervision and administration department shall supervise and inspect medical device advertisements and investigate and deal with illegal acts in accordance with the provisions of relevant laws and administrative regulations on advertisement management.
Article 78 The department responsible for drug supervision and administration shall, in accordance with the law, promptly publish daily supervision and management information such as medical device licenses, filings, spot-check tests, and the investigation and handling of illegal acts through the online government service platform of the State Council's drug supervision and administration department. However, the business secrets of the parties concerned shall not be disclosed.
The department responsible for drug supervision and administration shall establish credit files for medical device registrants, filers, production and operation enterprises, and users, increase the frequency of supervision and inspection for those with poor credit records, and strengthen credit punishment in accordance with the law.
Article 79 The department responsible for drug supervision and administration and other departments shall publish their contact information and accept consultations, complaints, and reports. Upon receiving consultations related to medical device supervision and management, the department responsible for drug supervision and administration and other departments shall respond promptly; upon receiving complaints and reports, they shall promptly verify, handle, and respond. The consultation, complaint, and reporting situations and their responses, verifications, and handling situations shall be recorded and preserved.
If a report on the research, development, production, operation, or use of medical devices is found to be true after investigation, the department responsible for drug supervision and administration and other departments shall reward the reporter. Relevant departments shall keep the reporter's information confidential.
Article 80 When the State Council's drug supervision and administration department formulates, adjusts, or modifies the catalogue stipulated in these Regulations and the norms related to medical device supervision and management, it shall publicly solicit opinions; it shall adopt forms such as hearings and symposiums to listen to the opinions of experts, medical device registrants, filers, production and operation enterprises, users, consumers, industry associations, and relevant organizations.
Chapter 7 Legal Liabilities
Article 81 In any of the following circumstances, the department responsible for drug supervision and administration shall confiscate the illegal gains, illegally produced and operated medical devices, and the tools, equipment, and raw materials used for illegal production and operation; if the value of the illegally produced and operated medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan and not more than 150,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times and not more than 30 times the value shall also be imposed; in serious cases, the offender shall be ordered to suspend production and business operations, and no application for medical device licenses shall be accepted from the relevant persons in charge and units within 10 years; for the legal representative, principal person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% and not more than 3 times the income shall also be imposed, and they shall be permanently prohibited from engaging in the production and operation of medical devices:
(1) Producing or operating Class II or Class III medical devices without obtaining a medical device registration certificate;
(2) Engaging in the production of Class II or Class III medical devices without a license;
(3) Engaging in the operation of Class III medical devices without a license.
In serious cases involving the circumstances in the preceding paragraph (1), the original issuing department shall revoke the medical device production license or medical device operation license.
Article 82 For the unauthorized installation and use of large medical equipment, the health administrative department of the county-level or above people's government shall order the cessation of use, give a warning, and confiscate the illegal gains; if the illegal gains are less than 10,000 yuan, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall also be imposed; if the illegal gains are 10,000 yuan or more, a fine of not less than 10 times and not more than 30 times the illegal gains shall also be imposed; in serious cases, no application for the configuration of large medical equipment shall be accepted from the relevant persons in charge and units within 5 years; for the legal representative, principal person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% and not more than 3 times the income shall also be imposed, and they shall be given disciplinary action in accordance with the law.
Article 83 For providing false materials or using other deceptive means when applying for medical device administrative licenses, the administrative license shall not be granted; if the administrative license has already been obtained, the department that made the administrative license decision shall revoke the administrative license, confiscate the illegal gains, and confiscate the illegally produced and operated medical devices; no application for medical device licenses shall be accepted from the relevant persons in charge and units within 10 years; if the value of the illegally produced and operated medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan and not more than 150,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times and not more than 30 times the value shall also be imposed; in serious cases, the offender shall be ordered to suspend production and business operations; for the legal representative, principal person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% and not more than 3 times the income shall also be imposed, and they shall be permanently prohibited from engaging in the production and operation of medical devices.
For forging, altering, buying, selling, renting, or lending relevant medical device license certificates, the original issuing department shall confiscate or revoke them, and confiscate the illegal gains; if the illegal gains are less than 10,000 yuan, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall also be imposed; if the illegal gains are 10,000 yuan or more, a fine of not less than 10 times and not more than 20 times the illegal gains shall also be imposed; if it constitutes a violation of public security management, the public security organs shall impose public security management penalties in accordance with the law.
Article 84 The following acts shall be subject to public announcement by the department in charge of drug supervision and administration of the names of the units and products involved, and an order to rectify within a time limit; if the rectification is not completed within the time limit, the illegal gains and illegally produced and operated medical devices shall be confiscated; if the value of the illegally produced and operated medical devices is less than 10,000 yuan, a fine of not less than 10,000 yuan and not more than 50,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times and not more than 20 times the value shall also be imposed; in serious cases, the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit shall be subject to confiscation of income obtained from the unit during the period of the illegal act, and a fine of not less than 30% and not more than 2 times the income, and shall be prohibited from engaging in the production and operation of medical devices for 5 years:
(1) Production and operation of Class I medical devices that have not been filed;
(2) Unregistered production of Class I medical devices;
(3) Operation of Class II medical devices that should be filed but have not been filed;
(4) The filed materials do not meet the requirements.
Article 85 For providing false information during filing, the department in charge of drug supervision and administration shall publicly announce the filing unit and product name, confiscate the illegal gains and illegally produced and operated medical devices; if the value of the illegally produced and operated medical devices is less than 10,000 yuan, a fine of not less than 20,000 yuan and not more than 50,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times and not more than 20 times the value shall also be imposed; in serious cases, the unit shall be ordered to suspend production and business operations, and the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit shall be subject to confiscation of income obtained from the unit during the period of the illegal act, and a fine of not less than 30% and not more than 3 times the income, and shall be prohibited from engaging in the production and operation of medical devices for 10 years.
Article 86 For any of the following acts, the department in charge of drug supervision and administration shall order rectification, confiscate the illegally produced and operated medical devices; if the value of the illegally produced and operated medical devices is less than 10,000 yuan, a fine of not less than 20,000 yuan and not more than 50,000 yuan shall also be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times and not more than 20 times the value shall also be imposed; in serious cases, the unit shall be ordered to suspend production and business operations, until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device business license, and the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit shall be subject to confiscation of income obtained from the unit during the period of the illegal act, and a fine of not less than 30% and not more than 3 times the income, and shall be prohibited from engaging in the production and operation of medical devices for 10 years:
(1) Production, operation, or use of medical devices that do not meet mandatory standards or the technical requirements of registered or filed products;
(2) Failure to organize production in accordance with the technical requirements of registered or filed products, or failure to establish and maintain an effective quality management system as stipulated in these Regulations, affecting product safety and effectiveness;
(3) Operation or use of medical devices without qualified certificates, expired, invalid, or obsolete medical devices, or use of unregistered medical devices;
(4) Refusal to recall after being ordered to recall by the department in charge of drug supervision and administration, or refusal to stop production, import, or operation after being ordered to stop or suspend production, import, or operation of medical devices by the department in charge of drug supervision and administration;
(5) Entrusting enterprises that do not meet the conditions stipulated in these Regulations to produce medical devices, or failure to manage the production behavior of the entrusted production enterprises;
(6) Import of expired, invalid, obsolete, or used medical devices.
Article 87 If a medical device business enterprise or user has fulfilled the obligations such as incoming goods inspection as stipulated in these Regulations, and has sufficient evidence to prove that it did not know that the medical devices it operated or used were medical devices as stipulated in Article 81, paragraph 1, item (1), Article 84, item (1), Article 86, item (1), and item (3) of these Regulations, and can truthfully explain its source of goods, the confiscated medical devices that do not meet the legal requirements may be exempted from administrative penalties.
Article 88 For any of the following acts, the department in charge of drug supervision and administration shall order rectification and impose a fine of not less than 10,000 yuan and not more than 50,000 yuan; if rectification is refused, a fine of not less than 50,000 yuan and not more than 100,000 yuan shall be imposed; in serious cases, the unit shall be ordered to suspend production and business operations, until the original issuing department revokes the medical device production license and medical device business license, and the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit shall be subject to confiscation of income obtained from the unit during the period of the illegal act, and a fine of not less than 30% and not more than 2 times the income, and shall be prohibited from engaging in the production and operation of medical devices for 5 years:
(1) Changes in production conditions, no longer meeting the requirements of the medical device quality management system, failure to rectify, stop production, or report as stipulated in these Regulations;
(2) Production and operation of medical devices with instructions and labels that do not comply with the provisions of these Regulations;
(3) Failure to transport and store medical devices in accordance with the instructions and labels;
(4) Transfer of expired, invalid, obsolete, or unqualified medical devices in use.
Article 89 For any of the following acts, the department in charge of drug supervision and administration and the health authority shall, in accordance with their respective responsibilities, order rectification and give a warning; if rectification is refused, a fine of not less than 10,000 yuan and not more than 100,000 yuan shall be imposed; in serious cases, the unit shall be ordered to suspend production and business operations, until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device business license, and the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the illegal unit shall be fined not less than 10,000 yuan and not more than 30,000 yuan:
(1) Failure to submit a self-inspection report on the quality management system as required;
(2) Purchasing medical devices from suppliers without legal qualifications;
(3) Medical device business enterprises and users failing to establish and implement a medical device incoming goods inspection record system as stipulated in these Regulations;
(4) Business enterprises engaged in the wholesale of Class II and Class III medical devices and the retail of Class III medical devices failing to establish and implement a sales record system as stipulated in these Regulations;
(5) Medical device registrants, filers, production and operation enterprises, and users failing to conduct medical device adverse event monitoring as stipulated in these Regulations, failing to report adverse events as required, or failing to cooperate with the investigation of adverse events conducted by medical device adverse event monitoring technical institutions, the department in charge of drug supervision and administration, and the health authority;
(6) Medical device registrants and filers failing to formulate and effectively implement post-market research and risk control plans as stipulated;
(7) Medical device registrants and filers failing to establish and implement a product traceability system as stipulated;
(8) Medical device registrants, filers, and business enterprises engaged in online sales of medical devices failing to inform the department in charge of drug supervision and administration as stipulated;
9. For medical devices that require regular inspection, testing, calibration, maintenance, and servicing, the medical device user unit fails to conduct inspections, tests, calibrations, maintenance, and servicing in accordance with the product instructions, and to record, analyze, and evaluate them in a timely manner to ensure that the medical devices are in good condition;
10. The medical device user unit fails to properly preserve the original data of purchased Class III medical devices.
Article 90 Those who have any of the following circumstances shall be ordered by the health administrative department of the people's government at or above the county level to make corrections and be given a warning; those who refuse to make corrections shall be fined more than 50,000 yuan but less than 100,000 yuan; for serious cases, a fine of more than 100,000 yuan but less than 300,000 yuan shall be imposed, and the relevant medical device use activities shall be ordered to be suspended until the original licensing department revokes the business license, and the relevant responsible personnel shall be ordered to suspend their practice activities for 6 months to 1 year, until the original licensing department revokes the relevant personnel's practice certificates. The legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit shall have the income obtained from the unit during the period of the illegal act confiscated, and a fine of 30% to 3 times the income shall be imposed, and disciplinary action shall be taken in accordance with the law:
1. For reusable medical devices, the medical device user unit fails to handle them in accordance with the regulations on disinfection and management;
2. The medical device user unit reuses disposable medical devices, or fails to destroy used disposable medical devices as prescribed;
3. The medical device user unit fails to record the information of large medical devices and implantable and interventional medical devices in medical records and other relevant records as prescribed;
4. The medical device user unit discovers that the medical devices in use have safety hazards but fails to immediately stop using them, notify for repair, or continues to use medical devices that still cannot meet the safety standards after repair;
5. The medical device user unit uses large medical equipment in violation of regulations, which cannot guarantee the safety and quality of medical treatment.
Article 91 Medical devices imported in violation of relevant laws and administrative regulations on import and export commodity inspection shall be handled in accordance with the law by the entry-exit inspection and quarantine agency.
Article 92 E-commerce platform operators providing services for medical device online transactions violate the provisions of these Regulations and fail to fulfill their management obligations, such as conducting real-name registration of online medical device operators, reviewing licensing, registration, and filing situations, stopping and reporting illegal acts, and stopping providing online transaction platform services, shall be punished by the department in charge of drug supervision and administration in accordance with the provisions of the "E-commerce Law of the People's Republic of China".
Article 93 For those who conduct clinical trials without filing for medical device clinical trial institutions, the department in charge of drug supervision and administration shall order the clinical trial to be stopped and corrected; those who refuse to make corrections shall not use the clinical trial data for product registration or filing, and shall be fined more than 50,000 yuan but less than 100,000 yuan, and shall be publicly announced; for those who cause serious consequences, they shall be prohibited from conducting relevant professional medical device clinical trials within 5 years, and shall be fined more than 100,000 yuan but less than 300,000 yuan. The health administrative department shall confiscate the income obtained by the illegal unit from the unit during the period of the illegal act, and impose a fine of 30% to 3 times the income, and give disciplinary action in accordance with the law to the legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit.
For clinical trial applicants who conduct clinical trials without filing, the department in charge of drug supervision and administration shall order the clinical trial to be stopped, and shall fine the clinical trial applicant more than 50,000 yuan but less than 100,000 yuan, and shall be publicly announced; for those who cause serious consequences, a fine of more than 100,000 yuan but less than 300,000 yuan shall be imposed. The clinical trial data shall not be used for product registration or filing, and no application for medical device registration shall be accepted from the relevant responsible person and unit within 5 years.
For clinical trial applicants who conduct clinical trials of Class III medical devices with high risks to the human body without approval, the department in charge of drug supervision and administration shall order the clinical trial to be stopped immediately, and shall fine the clinical trial applicant more than 100,000 yuan but less than 300,000 yuan, and shall be publicly announced; for those who cause serious consequences, a fine of more than 300,000 yuan but less than 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration, and no application for medical device clinical trial and registration shall be accepted from the relevant responsible person and unit within 10 years. The legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit shall have the income obtained from the unit during the period of the illegal act confiscated, and a fine of 30% to 3 times the income shall be imposed.
Article 94 For medical device clinical trial institutions that conduct medical device clinical trials without complying with the clinical trial quality management specifications, the department in charge of drug supervision and administration shall order corrections or immediate cessation of the clinical trial, and impose a fine of more than 50,000 yuan but less than 100,000 yuan; for those who cause serious consequences, they shall be prohibited from conducting relevant professional medical device clinical trials within 5 years. The health administrative department shall confiscate the income obtained by the illegal unit from the unit during the period of the illegal act, and impose a fine of 30% to 3 times the income, and give disciplinary action in accordance with the law to the legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit.
Article 95 For medical device clinical trial institutions that issue false reports, the department in charge of drug supervision and administration shall impose a fine of more than 100,000 yuan but less than 300,000 yuan; for those with illegal gains, the illegal gains shall be confiscated; they shall be prohibited from conducting relevant professional medical device clinical trials within 10 years; the health administrative department shall confiscate the income obtained by the illegal unit from the unit during the period of the illegal act, and impose a fine of 30% to 3 times the income, and give disciplinary action in accordance with the law to the legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit.
Article 96 For medical device testing institutions that issue false testing reports, the competent authority that grants them qualifications shall revoke their testing qualifications, and no application for qualification certification shall be accepted from the relevant responsible person and unit within 10 years, and a fine of more than 100,000 yuan but less than 300,000 yuan shall be imposed; for those with illegal gains, the illegal gains shall be confiscated; the legal representative, main person in charge, person directly in charge, and other responsible personnel of the illegal unit shall have the income obtained from the unit during the period of the illegal act confiscated, and a fine of 30% to 3 times the income shall be imposed, and disciplinary action shall be taken in accordance with the law; those who are dismissed from their posts shall be prohibited from engaging in medical device testing work within 10 years.
Article 97 Violations of the provisions of these Regulations on the management of medical device advertisements shall be punished in accordance with the provisions of the "Advertising Law of the People's Republic of China".
Article 98 For domestic corporate legal persons designated by overseas medical device registrants and filers who fail to fulfill their relevant obligations as prescribed in these Regulations, the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall order corrections, give warnings, and impose a fine of more than 50,000 yuan but less than 100,000 yuan; for serious cases, a fine of more than 100,000 yuan but less than 500,000 yuan shall be imposed, and their legal representatives, main persons in charge, persons directly in charge, and other responsible personnel shall be prohibited from engaging in medical device production and operation activities within 5 years.
Overseas medical device registrants and filers who refuse to fulfill the administrative penalty decisions made in accordance with these Regulations shall be prohibited from importing medical devices within 10 years.
Article 99 For medical device research, production, operation units and testing institutions that violate the provisions of these Regulations and use personnel prohibited from engaging in medical device production, operation, and testing work, the department in charge of drug supervision and administration shall order corrections and give warnings; those who refuse to make corrections shall be ordered to suspend production and business operations until their licenses are revoked.
Article 100. If a medical device technical review institution or a medical device adverse event monitoring technical institution fails to perform its duties as stipulated in this Regulation, resulting in major errors in review or monitoring work, the department in charge of drug supervision and administration shall order it to rectify, issue a public criticism, and give a warning; if serious consequences are caused, the legal representative, main person in charge, directly responsible person in charge, and other responsible personnel of the violating unit shall be given administrative sanctions according to law.
Article 101. If a staff member of the department in charge of drug supervision and administration or other relevant departments violates the provisions of this Regulation and abuses power, neglects duty, or practices favoritism and malpractice for personal gain, they shall be given administrative sanctions according to law.
Article 102. If a violation of this Regulation constitutes a crime, criminal liability shall be investigated according to law; if personal injury, property damage, or other damages are caused, compensation liability shall be borne according to law.
Chapter 8 Supplementary Provisions
Article 103. The meanings of the following terms in this Regulation are:
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrators, materials, and other similar or related articles used directly or indirectly on the human body, including the necessary computer software; their efficacy is mainly obtained through physical means, not through pharmacological, immunological, or metabolic means, or although these means are involved, they only play an auxiliary role; their purpose is:
(1) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries;
(3) Examination, replacement, regulation, or support of physiological structures or physiological processes;
(4) Support or maintenance of life;
(5) Pregnancy control;
(6) Providing information for medical or diagnostic purposes by examining samples from the human body.
Registrant and filer of medical devices refer to enterprises or research institutions that have obtained medical device registration certificates or have completed medical device filing.
Medical device user units refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, family planning technical service institutions, blood banks, single plasma collection stations, rehabilitation assistive device adaptation institutions, etc.
Large medical equipment refers to large medical devices that are technically complex, require large capital investment, have high operating costs, have a significant impact on medical expenses, and are included in the catalog management.
Article 104. Fees may be charged for the registration of medical device products. Specific charging items and standards shall be formulated by the State Council's finance and pricing authorities in accordance with relevant national regulations.
Article 105. The management measures for medical devices developed by medical and health institutions to respond to public health emergencies shall be formulated by the State Council's drug supervision and administration department in conjunction with the State Council's health authority.
The storage, allocation, and supply of non-profit contraceptive medical devices shall comply with the management measures formulated by the State Council's health authority in conjunction with the State Council's drug supervision and administration department.
The technical guidelines for traditional Chinese medicine medical devices shall be formulated by the State Council's drug supervision and administration department in conjunction with the State Council's traditional Chinese medicine administration department.
Article 106. The supervision and management of the use of medical devices in the military shall be implemented in accordance with this Regulation and relevant military regulations.
Article 107. This Regulation shall come into force on June 1, 2021.
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