Chapter 1 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 development, production, operation, and use of medical devices within the territory of the People's Republic of China, as well as their supervision and management.

Article 3 The drug administration department of the State Council is responsible for the supervision and administration of medical devices nationwide.

The relevant departments of the State Council shall be responsible for the supervision and management of medical devices within the scope of their respective duties.

Article 4 Local people's governments at or above the county level shall strengthen their leadership over the supervision and management of medical devices in their respective administrative regions, organize and coordinate the supervision and management of medical devices within their respective administrative regions and emergency response work, strengthen the capacity building of medical device supervision and management, and provide guarantees for medical device safety work.

The departments responsible for drug supervision and administration of local people's governments at or above the county level shall be responsible for the supervision and management of medical devices in their respective administrative regions. The relevant departments of local people's governments at or above the county level shall be responsible for the supervision and management of medical devices within the scope of their respective duties.

Article 5 The supervision and management of medical devices shall follow the principles of risk management, whole-process control, scientific supervision, and social co-governance.

Article 6 The state shall classify medical devices according to the degree of risk.

The first category is medical devices with low risk and can be ensured by routine management.

The second category is medical devices with moderate risk and require strict control and management to ensure their safety and effectiveness.

The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.

The risk level of medical devices should be evaluated by considering factors such as the intended purpose, structural characteristics, and usage methods of medical devices.

The drug regulatory department of the State Council is responsible for formulating classification rules and classification catalogs for medical devices, and timely analyzing and evaluating risk changes in medical devices according to the production, operation and use of medical devices, and adjusting the classification rules and classification catalogs. The formulation and adjustment of classification rules and classification catalogs shall fully listen to the opinions of medical device registrants, filers, production and operation enterprises, user units and industry organizations, and refer to the international medical device classification practice. The classification rules and classification catalogues of medical devices shall be published to the public.

Article 7 Medical device products shall comply with the mandatory national standards for medical devices; If there are no mandatory national standards, they shall comply with the mandatory industry standards for medical devices.

Article 8 The state formulates medical device industry plans and policies, incorporates medical device innovation into the development focus, gives priority to the review and approval of 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 under the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and guidance policies.

Article 9 The state shall improve the medical device innovation system, support basic and applied research on medical devices, promote the promotion and application of new medical device technologies, and provide support in scientific and technological project approval, financing, credit, bidding and procurement, medical insurance, etc. Support enterprises to set up or jointly establish research and development institutions, encourage enterprises to cooperate with universities, scientific research institutes, medical institutions, etc. to carry out research and innovation of medical devices, strengthen the protection of intellectual property rights of medical devices, and improve the ability of independent innovation of medical devices.

Article 10 The state shall strengthen the informatization of medical device supervision and management, improve the level of online government services, and provide convenience for administrative licensing and filing of medical devices.

Article 11 Medical device industry organizations shall strengthen industry self-discipline, promote the construction of an integrity system, urge enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy.

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 2 Medical Device Product Registration and Filing

Article 13 Class I medical devices shall be subject to product filing management, and Class II and Class III medical devices shall be subject to product registration management.

Medical device registrants and filers shall strengthen the quality management of the whole life cycle of medical devices, and be responsible for the safety and effectiveness of medical devices in the whole process of development, production, operation, and use in accordance with the law.

Article 14 The following materials shall be submitted for the filing of Class I medical device products and the application for registration of Class II and Class III medical device products:

(1) Product risk analysis data;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product manual and label sample;

(6) Quality management system documents related to product development and production;

(7) Other materials required to prove the safety and effectiveness of the product.

The product inspection report shall meet the requirements of the drug administration department of the State Council, which can be the self-inspection report of the medical device registration applicant and filer, or the inspection report issued by a qualified medical device inspection agency.

Those who meet the circumstances of exemption from clinical evaluation as provided for in Article 24 of these Regulations may be exempted from submitting clinical evaluation materials.

Medical device registration applicants and filers shall ensure that the submitted information is legal, true, accurate, complete and traceable.

Article 15 For the filing of Class I medical device products, the filer shall submit the filing materials to the department responsible for drug supervision and administration of the people's government at the districted municipal level where the filing is located.

The overseas filer who exports Class I medical devices to our country China shall submit the filing materials to the drug administration department of our country the State Council and the documents proving that the competent authority of the country (region) where the filer is located approves the listing and sale of the medical device. Innovative medical devices that have not been marketed overseas may not submit the documents proving that the competent authority of the country (region) where the filer is located approves the listing and sale of the medical device.

The filer shall complete the filing after submitting the filing 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 publish the relevant information on the filing to the public through the online government service platform of the drug supervision and administration department under the State Council within 5 working days from the date of receipt of the filing materials.

If the matters specified in the filing materials change, the filing shall be changed to the original filing department.

Article 16 When applying for registration of Class II medical device products, the registration applicant shall submit the registration application materials to the drug 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 the registration application materials to the drug administration department of the State Council.

For overseas registration applicants exporting Class II and Class III medical devices to our country China, the legal person designated by the our country domestic enterprise shall submit the registration application materials and the documents proving that the competent authority of the country (region) where the registration applicant is located approves the listing and sale of the medical device. Innovative medical devices that are not listed overseas may not submit the documents proving that the competent authority of the country (region) where the registration applicant is located allows the medical device to be marketed and sold.

The drug administration department under the State Council shall stipulate the procedures and requirements for medical device registration review, and strengthen the supervision and guidance of the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

Article 17 The drug regulatory department accepting the registration application shall review the safety and effectiveness of the medical device and the registration applicant's ability to ensure the safety and effective quality management of the medical device.

The drug regulatory department accepting the registration application shall transfer the registration application materials to the technical review agency within 3 working days from the date of acceptance of the registration application. After completing the technical review, the technical review agency shall submit the review opinions to the drug regulatory department accepting the registration application as the basis for approval.

If the drug regulatory department accepting the registration application deems it necessary to verify the quality management system when organizing the technical review of the medical device, it shall organize the verification of the quality management system.

Article 18 The drug regulatory department accepting the registration application shall make a decision within 20 working days from the date of receipt of the review opinion. For those who meet the requirements, registration shall be approved and a medical device registration certificate shall be issued; those who do not meet the requirements will not be registered and explain the reasons in writing.

The drug regulatory department accepting the registration application shall publish the relevant registration information to the public through the online government service platform of the drug regulatory department of the State Council within 5 working days from the date of approval of the registration of the medical device.

Article 19 For medical devices urgently needed for the treatment of rare diseases, seriously life-threatening diseases for which there is no effective treatment, and public health incidents, the drug regulatory department accepting the registration application may make a conditional approval decision and specify the relevant matters in the medical device registration certificate.

In the event of a particularly major public health emergency or other emergency that seriously threatens public health, the competent health department under the State Council and the disease prevention and control department under the State Council shall put forward recommendations for the emergency use of medical devices according to the needs of prevention and control of the incident.

Article 20 Medical device registrants and filers shall perform the following obligations:

(1) Establish a quality management system suitable for the product and maintain effective operation;

(2) Formulate post-market research and risk control plans and ensure effective implementation;

(3) Carry out monitoring and re-evaluation of adverse events in accordance with law;

(4) Establish and implement product traceability and recall systems;

(5) Other obligations stipulated by the drug administration department under the State Council.

The legal person of our country's domestic enterprise designated by the overseas medical device registrant or filer shall assist the registrant or filer in performing the obligations stipulated in the preceding paragraph.

Article 21 If the design, raw materials, production process, scope of application, and usage methods of registered Class II or Class III medical device products undergo substantial changes, which may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department to go through the registration procedures for change; If other changes occur, they shall be filed or reported in accordance with the provisions of the drug administration department under the State Council.

Article 22 The medical device registration certificate is valid for 5 years. If it is necessary to renew the registration after the expiration of the validity period, an application for renewal of registration shall be submitted to the original registration department 6 months before the expiration of the validity period.

Except for the circumstances provided in paragraph 3 of this article, the drug regulatory department receiving the application for renewal of registration shall make a decision to approve the renewal before the expiration of the validity period of the medical device registration certificate. if no decision is made within the time limit, it shall be deemed to be allowed to continue.

In any of the following circumstances, the registration shall not be renewed:

(1) Failure to submit an application for renewal of registration within the prescribed time limit;

(2) The mandatory standards for medical devices have been revised, and the medical devices applying for renewal of registration cannot meet the new requirements;

(3) Conditionally approved medical devices that fail to complete the matters specified in the medical device registration certificate within the specified time limit.

Article 23 For newly developed medical devices that have not yet been included in the classification catalogue, the applicant may directly apply for product registration in accordance with the provisions of these Regulations on the registration of Class III medical devices, or may judge the product category according to the classification rules and apply to the drug administration department of the State Council for category confirmation and apply for product registration or product filing in accordance with the provisions of these Regulations.

If a person directly applies for the registration of a Class III medical device product, the drug administration department of the State Council shall determine the category according to the degree of risk and promptly include the approved medical device in the classification catalogue. If the application category is confirmed, the drug administration department of the State Council shall determine the category of the medical device and inform the applicant within 20 working days from the date of acceptance of the application.

Article 24 Clinical evaluation shall be conducted for the registration and filing of medical device products; However, clinical evaluation may be exempted from clinical evaluation in any of the following situations:

(1) The working mechanism is clear, the design is finalized, the production process is mature, and the medical device of the same type has been used clinically for many years without serious adverse events recorded, and the conventional use has not changed;

(2) Other medical devices that can be proved to be safe and effective through non-clinical evaluation.

The drug administration department of the State Council shall formulate guidelines for clinical evaluation of medical devices.

Article 25 Clinical evaluation of medical devices may be conducted based on product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of clinical literature and clinical data of the same type of medical device, to prove the safety and effectiveness of medical devices.

According to the provisions of the drug administration department of the State Council, when conducting clinical evaluation of medical devices, clinical trials should be carried out if the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the product.

Article 26 Medical device clinical trials shall be carried out in clinical trial institutions with corresponding conditions in accordance with the requirements of the medical device clinical trial quality management specifications, and shall be filed with the drug supervision and administration department of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government where the clinical trial sponsor is located. The drug regulatory department accepting clinical trial filing shall notify the drug regulatory department at the same level and the competent health department at the same level where the clinical trial institution is located.

Medical device clinical trial institutions shall implement filing management. The conditions that medical device clinical trial institutions should have, the filing management measures and clinical trial quality management specifications shall be formulated and published by the drug administration department of the State Council in conjunction with the health department of the State Council.

The state supports medical institutions to carry out clinical trials, incorporates clinical trial conditions and capability evaluation into the evaluation of medical institutions, and encourages medical institutions to carry out clinical trials of innovative medical devices.

Article 27 Clinical trials of Class III medical devices that pose high risks to the human body shall be approved by the drug administration department of the State Council. When approving a clinical trial, the drug regulatory department of the State Council shall conduct a comprehensive analysis of the equipment, professional personnel and other conditions of the institution to undertake the clinical trial of the medical device, the risk degree of the medical device, the clinical trial implementation plan, and the clinical benefit and risk comparison analysis report, etc., and make a decision and notify the clinical trial sponsor within 60 working days from the date of acceptance of the application. if the notice is not given within the time limit, it shall be deemed to have been agreed. Where clinical trials are approved, they shall be notified to the drug regulatory departments and health authorities of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government where the clinical trial institutions are located.

The list of Class III medical devices with high risks to the human body in clinical trials shall be formulated, adjusted and published by the drug administration department of the State Council.

Article 28 When conducting clinical trials of medical devices, ethical review shall be conducted in accordance with regulations, and subjects shall be informed of the purpose and use of the trial, as well as possible risks, and obtain written informed consent from subjects. If the subject is a person without or with limited civil capacity, the written informed consent of his or her guardian shall be obtained in accordance with law.

Conduct clinical trials and do not charge subjects in any form related to clinical trials.

Article 29 Medical devices that are undergoing clinical trials for the treatment of seriously life-threatening diseases for which there are no effective treatment methods may benefit patients after medical observation, and after ethical review and informed consent, they may be used free of charge for other patients with the same condition in the institution conducting clinical trials of medical devices, and their safety data may be used for medical device registration applications.

Chapter 3 Medical Device Production

Article 30 Engaging in medical device production activities shall meet the following conditions:

(1) There are production sites, environmental conditions, production equipment, and professional and technical personnel suitable for the medical devices being produced;

(2) There are institutions or full-time inspectors and inspection equipment that can conduct quality inspection of the produced medical devices;

(3) There is a management system to ensure the quality of medical devices;

(4) Have after-sales service capabilities suitable for the medical devices produced;

(5) Meet the requirements of product 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 people's government at the districted municipality where they are located, and complete the filing after submitting relevant materials that meet the conditions stipulated in Article 30 of these Regulations.

If the medical device filer manufactures Class I medical devices by himself, he or she may submit relevant materials that meet the conditions stipulated in Article 30 of these Regulations when filing the product in accordance with Article 15 of these Regulations, that is, the production filing shall be completed.

Article 32 Those engaged in the production of Class II and Class III medical devices shall apply for a production license from the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located, and submit relevant materials that meet the conditions stipulated in Article 30 of these Regulations and the registration certificate of the medical device produced.

The drug regulatory department accepting the application for a production license shall review the application materials, verify them in accordance with the requirements of the medical device production quality management specifications formulated by the drug regulatory department of the State Council, and make a decision within 20 working days from the date of acceptance of the application. If the specified conditions are met, the license shall be granted and a medical device production license shall be issued; If the prescribed conditions are not met, permission shall not be granted and the reasons shall be explained in writing.

The medical device production license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be carried out in accordance with the relevant administrative licensing laws.

Article 33 The quality management specifications for medical devices shall clearly stipulate 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, and institutional setup and staffing of enterprises.

Article 34 Medical device registrants and filers may produce medical devices on their own, or they may entrust enterprises that meet the provisions of these Regulations and meet the corresponding conditions to produce medical devices.

If the production of medical devices is entrusted, the medical device registrant and filer shall be responsible for the quality of the entrusted medical devices, and strengthen the management of the production behavior of the entrusted manufacturer to ensure that it is produced in accordance with the legal requirements. The medical device registrant and filer shall sign an entrustment agreement with the entrusted manufacturer to clarify the rights, obligations and responsibilities of both parties. The entrusted manufacturer shall organize production in accordance with laws and regulations, medical device production quality management specifications, mandatory standards, product technical requirements and entrustment agreements, be responsible for production behavior, and accept the supervision of the entrusting party.

High-risk implantable medical devices shall not be commissioned for production, and the specific catalogue shall be formulated, adjusted and published by the drug administration department of the State Council.

Article 35 Medical device registrants, filers, and entrusted manufacturers shall establish and improve a quality management system suitable for the medical devices produced in accordance with the medical device production quality management specifications and ensure their effective operation; Organize production in strict accordance with the technical requirements of registered or filed products to ensure that the medical devices leaving the factory meet the mandatory standards and the technical requirements of registered or filed products.

Medical device registrants, filers, and entrusted manufacturers shall conduct regular self-inspections on the operation of the quality management system and submit self-inspection reports in accordance with the provisions of the drug administration department under the State Council.

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 manufacturer shall immediately take corrective measures; If it may affect the safety and effectiveness of medical devices, production activities shall be stopped immediately and reported to the original production license or production filing department.

Article 37 Medical devices shall use generic names. Generic names shall comply with the medical device naming rules formulated by the drug administration department of the State Council.

Article 38 The state shall implement the unique identification system for medical devices step by step according to the category of medical device products to realize the traceability of medical devices, and the specific measures shall be formulated by the drug regulatory department of the State Council 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 relevant content registered or filed to ensure authenticity and accuracy.

The instructions and labels of medical devices shall indicate the following matters:

(1) Generic name, model, and specification;

(2) The name, address and contact information of the medical device registrant, filer and entrusted manufacturer;

(3) The date of production, the period of use or the date of expiration;

(4) Product performance, main structure, and scope of application;

(5) Contraindications, precautions, and other content that needs to be warned or prompted;

(6) Instructions or illustrations for installation and use;

(7) Maintenance and maintenance methods, special transportation and storage conditions and methods;

(8) Other contents that should be indicated in the technical requirements of the product.

Class II and Class III medical devices shall also indicate the medical device registration certificate number.

Medical devices used by consumers should also have special instructions for safe use.

Chapter 4 Medical Device Operation and Use

Article 40 Engaging in medical device business activities shall have business premises and storage conditions suitable for the scale and scope of operation, as well as quality management systems and quality management institutions or personnel suitable for the medical devices being operated.

Article 41 Where the business is engaged in the operation of Class II medical devices, the operating enterprise shall file with the department responsible for drug supervision and administration of the people's government at the district level where it is located and submit relevant materials that meet the conditions stipulated in Article 40 of these Regulations.

According to the regulations of the drug administration department of the State Council, Class II medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing.

Article 42 Where a person engages in the operation of Class III medical devices, the operating enterprise shall apply for a business license from the department responsible for drug supervision and administration of the people's government at the districted municipality where it is located and submit relevant materials that meet the conditions stipulated in Article 40 of these Regulations.

The department responsible for drug supervision and administration accepting the application for a business license shall review the application materials, organize verification if necessary, and make a decision within 20 working days from the date of acceptance of the application. if the specified conditions are met, a license shall be granted and a medical device business license shall be issued; If the prescribed conditions are not met, permission shall not be granted and the reasons shall be explained in writing.

The medical device business license is valid for 5 years. If the validity period expires and needs to be renewed, the renewal procedures shall be carried out in accordance with the relevant administrative licensing laws.

Article 43 Medical device registrants and filers operating their registered or registered medical devices do not need to apply for a medical device business license or filing, but shall comply with the business conditions stipulated in these Regulations.

Article 44 Engaging in medical device business shall establish and improve a quality management system suitable for the medical device operated and ensure its effective operation in accordance with laws and regulations and the requirements of the medical device operation quality management specifications formulated by the drug administration department of the State Council.

Article 45 Medical device business enterprises and users shall purchase medical devices from legally qualified medical device registrants, filers, and production and operation enterprises. When purchasing medical devices, the qualifications of the supplier and the qualification certificates of the medical devices shall be checked, and a purchase inspection record system shall be established. Enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall also establish a sales record system.

Records include:

(1) Name, model, specification, and quantity of medical devices;

(2) The production batch number, expiration date, and sales date of the medical device;

(3) The name of the medical device registrant, filer and entrusted manufacturer;

(4) The name, address and contact information of the supplier or purchaser;

(5) Relevant license document number, etc.

Purchase inspection records and sales records shall be true, accurate, complete and traceable, and shall be kept within the time limit specified by the drug administration department under the State Council. The State encourages the use of advanced technology for recording.

Article 46 Those engaged in online sales of medical devices shall be medical device registrants, filers, or medical device business enterprises. Operators engaged in online sales of medical devices shall inform the departments responsible for drug supervision and administration of the people's governments at the districted municipalities where they are located, except for those engaged in the operation of Class I medical devices and Class II medical devices as provided for in paragraph 2 of Article 41 of these Regulations.

E-commerce platform operators providing services for online medical device transactions shall register the real-name registration of online medical device operators, review their business licenses and filings, and the registration and filing of medical device products they operate, and manage their business activities. If an e-commerce platform operator discovers that a network medical device operator has violated the provisions of these Regulations, it shall promptly stop and immediately report to the department responsible for drug supervision and administration of the people's government at the district level where the medical device operator is located; Where serious violations are discovered, the provision of online trading platform services shall be immediately stopped.

Article 47 The transportation and storage of medical devices shall comply with the requirements of medical device instructions and labeling; If there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.

Article 48 Medical device users shall have storage sites and conditions suitable for the types and quantities of medical devices in use. Medical device users shall strengthen technical training for staff and use medical devices in accordance with product manuals, technical operation specifications, and other requirements.

The allocation of large-scale medical equipment shall comply with the large-scale medical equipment configuration plan formulated by the health department of the State Council, adapt to its functional positioning and clinical service needs, have corresponding technical conditions, supporting facilities, and professional and technical personnel with corresponding qualifications and capabilities, and obtain a large-scale medical equipment configuration license with the approval of the health department of the people's government at or above the provincial level.

The administrative measures for the allocation of large-scale medical equipment shall be formulated by the health department of the State Council in conjunction with the relevant departments of the State Council. The catalogue of large-scale medical equipment shall be proposed by the health department of the State Council in consultation with the relevant departments of the State Council, and shall be implemented after approval by the State Council.

Article 49 Medical device users shall dispose of reused medical devices in accordance with the disinfection and management regulations formulated by the health department under the State Council.

Disposable medical devices shall not be reused, and those used shall be destroyed and recorded in accordance with relevant national regulations. The list of single-use medical devices shall be formulated, adjusted and published by the drug administration department of the State Council in conjunction with the health department of the State Council. Inclusion in the list of disposable medical devices should have sufficient evidence of non-reuse. Reuse can ensure safe and effective medical devices and are not included in the list of single-use medical devices. For medical devices that can ensure safety and effectiveness due to improved design, production technology, disinfection and sterilization technology, etc., the list of disposable medical devices shall be adjusted to allow reuse.

Article 50 Medical device users shall inspect, inspect, calibrate, maintain, and record medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance in accordance with the requirements of the product manual, and conduct timely analysis and evaluation to ensure that the medical devices are in good condition and ensure the quality of use. For large medical devices with a long service life, use files shall be established one by one to record their use, maintenance, transfer, actual use time, and other matters. The record keeping period shall not be less than 5 years after the expiration of the specified use period of the medical device.

Article 51 Medical device users shall properly preserve the original materials purchased for Class III medical devices and ensure that the information is traceable.

Where large medical devices and implantable and interventional medical devices are used, the name of the medical device, key technical parameters, and other information closely related to the quality and safety of use shall be recorded in medical records and other relevant records.

Article 52 If the medical device used is found to have potential safety hazards, the medical device user shall immediately stop using it and notify the medical device registrant, filer or other institution responsible for product quality to conduct maintenance; Medical devices that still cannot meet the safety standards after maintenance shall not continue to be used.

Article 53 For in vitro diagnostic reagents that are not yet marketed in China, qualified medical institutions may develop their own according to the clinical needs of their own units and use them in their own units under the guidance of licensed physicians. The specific management measures shall be formulated by the drug administration department of the State Council in conjunction with the health department of the State Council.

Article 54 The departments responsible for drug supervision and administration and the competent health departments shall supervise and manage the quality of medical devices and the use of medical devices in accordance with their respective duties.

Article 55 Medical device business enterprises and users shall not operate or use medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, and are expired, invalid, or obsolete.

Article 56 When transferring medical devices in use between medical device users, the transferor shall ensure the safety and effectiveness of the transferred medical devices, 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 2 of these Regulations.

Imported medical devices should have Chinese instructions and Chinese labels. The instructions and labels shall comply with the requirements of these Regulations and relevant mandatory standards, and specify the origin of the medical device and the name, address, and contact information of the enterprise legal person in our country designated by the overseas medical device registrant or filer. If there is no Chinese instruction manual or Chinese label, or if the instruction manual or label does not comply with the provisions of this article, it shall not be imported.

Medical institutions that import a small amount of Class II or Class III medical devices due to clinical urgency may be imported with the approval of the drug administration department of the State Council or the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government authorized by the State Council. Imported medical devices shall be used for specific medical purposes in designated medical institutions.

It is prohibited to import expired, invalid, obsolete and other used medical devices.

Article 58 Entry-Exit Inspection and Quarantine Institutions shall inspect imported medical devices in accordance with law; If the inspection is unqualified, it shall not be imported.

The drug administration department under the State Council shall promptly notify the State Entry-Exit Inspection and Quarantine Department of the registration and filing of imported medical devices. The entry-exit inspection and quarantine agency at the location of the import port shall promptly notify the department responsible for drug supervision and administration of the people's government at the district level where the import port is located to the customs clearance of imported medical devices.

Article 59 Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).

Article 60 The content of medical device advertisements shall be true and legal, subject to the medical device instructions registered or filed by the department responsible for drug supervision and administration, and shall not contain false, exaggerated, or misleading content.

Before publishing medical device advertisements, the advertising review organs determined by the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall review the content of the advertisements and obtain the approval number of medical device advertisements. It may not be published without censorship.

The drug regulatory departments of people's governments at or above the provincial level shall order the suspension of production, import, operation and use of medical devices, and shall not publish advertisements involving such medical devices during the suspension period.

The review measures for medical device advertisements shall be formulated by the market supervision and administration department under the State Council.

Chapter 5 Handling of Adverse Events and Recall of Medical Devices

Article 61 The state shall establish a monitoring system for adverse events of medical devices to collect, analyze, evaluate, and control adverse events of medical devices in a timely manner.

Article 62 Medical device registrants and filers shall establish a medical device adverse event monitoring system, assign adverse event monitoring institutions and personnel suitable for their products, take the initiative to carry out adverse event monitoring of their products, and report to the medical device adverse event monitoring technical institution for investigation, analysis, evaluation, product risk control, etc. in accordance with the provisions of the drug administration department under the State Council.

Medical device production and operation enterprises and users shall assist medical device registrants and filers in monitoring adverse events for medical devices produced, operated or used; If adverse events or suspected adverse events of medical devices are discovered, they shall be reported to the medical device adverse event monitoring technical institution in accordance with the provisions of the drug administration department under the State Council.

Other units and individuals have the right to report to the department responsible for drug supervision and administration or the medical device adverse event monitoring technical institution if they find adverse events or suspected adverse events of medical devices.

Article 63 The drug regulatory department under the State Council shall strengthen the construction of an information network for monitoring adverse events of medical devices.

Medical device adverse event monitoring technical institutions shall strengthen the monitoring of medical device adverse event information and actively collect adverse event information; If adverse events are found or reports of adverse events are received, they shall be verified in a timely manner, investigated, analyzed, and evaluated when necessary, and reported to the departments responsible for drug supervision and administration and the competent health departments and put forward suggestions for handling.

Medical device adverse event monitoring technical institutions shall publish contact information to facilitate medical device registrants, filers, production and operation enterprises, and users to report adverse medical device events.

Article 64 The department responsible for drug supervision and administration shall promptly take control measures such as issuing warning information and ordering the suspension of production, import, operation and use based on the results of the assessment of adverse events of medical devices.

The drug regulatory departments of people's governments at or above the provincial level shall work with the competent health departments at the same level and relevant departments to organize timely investigation and handling of adverse events of medical devices that cause sudden or mass serious injuries or deaths, and organize the strengthening of monitoring of similar medical devices.

The department responsible for drug supervision and administration shall promptly notify the competent health department at the same level of the monitoring of adverse events in medical device users.

Article 65 Medical device registrants, filers, production and business enterprises, and users shall cooperate with medical device adverse event monitoring technical institutions, departments responsible for drug supervision and administration, and health departments conducting medical device adverse event investigations.

Article 66 In any of the following circumstances, the medical device registrant or filer shall take the initiative to carry out the re-evaluation of the listed medical device:

(1) According to the development of scientific research, there are changes in the understanding of the safety and effectiveness of medical devices;

(2) The results of monitoring and evaluation of adverse events of medical devices indicate that the medical device may be defective;

(3) Other circumstances stipulated by the drug administration department of the State Council.

Medical device registrants and filers shall take corresponding control measures to improve the listed medical devices based on the re-evaluation results, and make registration changes or filing changes in accordance with regulations. If the re-evaluation results show that the listed medical device cannot be guaranteed to be safe and effective, the medical device registrant or filer shall take the initiative to apply for cancellation of the medical device registration certificate or cancel the filing; If the medical device registrant or filer fails to apply for cancellation of the medical device registration certificate or cancel the filing, the department responsible for drug supervision and administration shall cancel the medical device registration certificate or cancel the filing.

The drug regulatory departments of people's governments at or above the provincial level shall re-evaluate listed medical devices based on the monitoring and evaluation of adverse events of medical devices. If the re-evaluation results show that the listed medical device cannot be guaranteed to be safe and effective, the medical device registration certificate shall be cancelled or the filing shall be cancelled.

The department responsible for drug supervision and administration shall promptly announce to the public the cancellation of medical device registration certificates and the cancellation of filings. Medical devices whose medical device registration certificates have been cancelled or canceled shall not continue to be produced, imported, operated or used.

Article 67 If a medical device registrant or filer discovers that the medical device produced does not meet the mandatory standards, the technical requirements of the registered or filed product, or has other defects, it shall immediately stop production, notify the relevant business enterprises, users and consumers to stop operating and using, recall the medical device that has been put on the market, take measures such as remediation and destruction, record the relevant situation, release relevant information, and report the recall and handling of the medical device to the department responsible for drug supervision and management and the competent health department.

If a medical device entrusted manufacturer or operating enterprise discovers that the medical device produced or operated has the circumstances specified in the preceding paragraph, it shall immediately stop production or operation, notify the medical device registrant or filer, and record the suspension of production, 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, it shall be recalled immediately.

If the medical device registrant, filer, entrusted manufacturer, or operating enterprise fails to implement the recall or stop production or operation in accordance with the provisions of this article, the department responsible for drug supervision and administration may order it to recall or stop production or operation.

Chapter VI: Supervision and Inspection

Article 68 The state establishes a professional and professional inspector system to strengthen the supervision and inspection of medical devices.

Article 69 The department responsible for drug supervision and administration shall strengthen supervision and inspection of the quality of medical devices in the development, production, business activities and use of medical devices, and conduct key supervision and inspection on the following matters:

(1) Whether production is organized in accordance with the technical requirements of registered or filed products;

(2) Whether the quality management system maintains effective operation;

(3) Whether the production and operation conditions continue to meet the statutory requirements.

When 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 development, production, operation, and use of medical devices.

Article 70 The departments responsible for drug supervision and administration have the following functions and powers in supervision and inspection:

(1) Entering the site to carry out inspection and sample collection;

(2) Consulting, copying, sealing, and seizing relevant contracts, bills, account books, and other relevant materials;

(3) Sealing or seizing medical devices that do not meet legal requirements, illegally used spare parts and raw materials, and tools and equipment used for illegal production and operation of medical devices;

(4) Seize places engaged in medical device production and business activities in violation of these Regulations.

When conducting supervision and inspection, law enforcement certificates shall be presented to protect the trade secrets of the inspected unit.

Relevant units and individuals shall cooperate with supervision and inspection, provide relevant documents and materials, and must not conceal, refuse, or obstruct.

Article 71 The competent health department shall strengthen supervision and inspection of the use of medical devices in medical institutions. When carrying out supervision and inspection, they may enter medical institutions to consult and copy relevant files, records, and other relevant materials.

Article 72 If there are potential 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 in charge of drug supervision and administration may take measures such as warnings, responsibility interviews, 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 to suspend production, import, operation, and use, and issue safety warning information.

Article 73 The department responsible for drug supervision and administration shall strengthen the random inspection and inspection of medical devices produced, operated and used by medical device registrants, filers, production and operation enterprises and user units. Inspection fees and other fees shall not be charged for random inspections and inspections, and the required expenses shall be included in the budget of the government at the same level. The drug supervision and administration departments of people's governments at or above the provincial level shall promptly issue medical device quality announcements based on the results of random inspections.

The competent health department shall supervise and evaluate the use of large medical equipment; If illegal use or excessive inspection or treatment related to large medical equipment is discovered, it shall be immediately corrected and dealt with in accordance with law.

Article 74 If the department responsible for drug supervision and administration fails to promptly discover the safety systemic risks of medical devices or eliminate potential safety hazards of medical devices in the supervision and management area in a timely manner, the people's government at the same level or the department responsible for drug supervision and administration of the people's government at a higher level shall conduct an interview with its principal responsible person.

Where a local people's government fails to perform its duties on medical device safety and fails to eliminate major regional medical device safety hazards in a timely manner, the people's government at a higher level or the department responsible for drug supervision and administration of the people's government at a higher level shall conduct an interview with its principal responsible person.

The interviewed departments and local people's governments shall immediately take measures to rectify the supervision and management of medical devices.

Article 75 The qualification certification of medical device inspection institutions shall be managed in accordance with relevant national regulations. Medical devices may be inspected only by the certification and accreditation supervision and administration department of the State Council and the inspection institutions recognized by the drug supervision and administration department of the State Council.

If the department responsible for drug supervision and administration needs to inspect medical devices in the course of law enforcement, it shall entrust a qualified medical device inspection institution to conduct it and pay the relevant fees.

If the parties have objections to the inspection conclusion, they may submit an application for re-inspection to the department implementing the sampling inspection or the department responsible for drug supervision and administration at the higher level within 7 working days from the date of receipt of the inspection conclusion. The medical device inspection institution undertaking the re-inspection work shall make a re-inspection conclusion within the time specified by the drug regulatory department of the State Council. The re-inspection conclusion is the final inspection conclusion. The re-inspection agency and the preliminary inspection agency shall not be the same institution; if there is only one qualified inspection agency for the relevant inspection project, the undertaking department or personnel shall be changed during the re-inspection. The list of re-inspection institutions shall be published by the drug administration department of the State Council.

Article 76 For medical devices that may contain harmful substances or change the design, raw materials and production process of medical devices without authorization and have potential safety hazards, the medical device inspection agency may use the supplementary inspection items and inspection methods approved by the drug administration department under the State Council for inspection; The inspection conclusions obtained by using supplementary inspection items and inspection methods can 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 management department shall supervise and inspect medical device advertisements in accordance with the provisions of laws and administrative regulations related to advertising management, and investigate and deal with illegal acts.

Article 78 The department responsible for drug supervision and administration shall promptly publish daily supervision and management information such as medical device licensing, filing, spot checks and inspections, and investigation and handling of illegal acts in accordance with law through the online government service platform of the drug administration department under the State Council. However, the trade secrets of the parties must not be disclosed.

The departments responsible for drug supervision and administration shall establish credit files of medical device registrants, filers, production and operation enterprises, and users, increase the frequency of supervision and inspection of those with bad credit records, and strengthen punishment for dishonesty in accordance with law.

Article 79 The departments and other departments responsible for drug supervision and administration shall publish the contact information of their units and accept consultations, complaints, and reports. The departments responsible for drug supervision and administration shall respond promptly to inquiries related to the supervision and administration of medical devices; Complaints and reports shall be promptly verified, handled, and replied to. Consultations, complaints, and reports, as well as their responses, verifications, and handling, shall be recorded and preserved.

If the report on the development, production, operation, or use of medical devices is found to be true, the department responsible for drug supervision and administration and other departments shall reward the informant. Relevant departments shall keep the whistleblower confidential.

Article 80 The drug regulatory department under the State Council shall publicly solicit opinions when formulating, adjusting, and revising the catalogue and norms related to the supervision and administration of medical devices provided for in these Regulations; Listen to the opinions of experts, medical device registrants, filers, production and operation enterprises, users, consumers, industry associations and relevant organizations in the form of hearings and demonstrations.

Chapter VII Legal Responsibilities

Article 81 In any of the following circumstances, the department in charge of drug supervision and administration shall confiscate illegal gains, medical devices illegally produced and operated, and tools, equipment, raw materials, and other items used in illegal production and operation; if the value of medical devices illegally produced and operated is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of not less than 15 times but not more than 30 times the value of the goods shall be imposed; If the circumstances are serious, order the suspension of production and business, and refuse to accept medical device license applications submitted by relevant responsible persons and units within 10 years, and confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income earned, and prohibit them from engaging in medical device production and business activities for life:

(1) Producing and operating Class II and Class III medical devices that have not obtained a medical device registration certificate;

(2) Engaging in the production of Class II and Class III medical devices without permission;

(3) Engaging in Class III medical device business activities without permission.

If there is a situation in the first paragraph of the preceding paragraph or the circumstances are serious, the original issuing department shall revoke the medical device production license or medical device business license.

Article 82 Where large-scale medical equipment is allocated and used without permission, the competent health department of the people's government at or above the county level shall order it to stop use, give a warning, and confiscate illegal gains; if the illegal gains are less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the illegal gains are more than 10,000 yuan, a fine of 10 times but not more than 30 times the illegal gains shall be imposed; If the circumstances are serious, the application for a large-scale medical equipment configuration permit submitted by the relevant responsible person and the unit shall not be accepted within 5 years, and the legal representative, main responsible person, directly responsible supervisor and other responsible personnel of the illegal unit shall be confiscated the income obtained from the unit during the period of the illegal act, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and punishment shall be given in accordance with the law.

Article 83 Where false information is provided or other deceptive means are used when applying for an administrative license for medical devices, no administrative license shall be granted, and if an administrative license has been obtained, the department that made the administrative license decision shall revoke the administrative license, confiscate illegal gains, illegal production, operation, and use of medical devices, and shall not accept medical device license applications submitted by relevant responsible persons and units within 10 years; if the value of medical devices used in illegal production and operation is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of not less than 15 times but not more than 30 times the value of the goods shall be imposed; If the circumstances are serious, the legal representative, main responsible person, directly responsible supervisor and other responsible personnel of the illegal unit shall be confiscated from the income obtained from the unit during the period of the illegal act, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production and business activities for life.

If the relevant medical device licenses are forged, altered, bought, rented or lent out, 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 but not more than 100,000 yuan shall be imposed; if the illegal gains are more than 10,000 yuan, a fine of not less than 10 times but not more than 20 times the illegal gains shall be imposed; if it constitutes a violation of public security administration, the public security organs shall impose public security administrative penalties in accordance with law.

Article 84 In any of the following circumstances, the department responsible for drug supervision and administration shall announce the unit and product name to the public and order correction within a time limit; if corrections are not made within the time limit, illegal gains and medical devices illegally produced and operated shall be confiscated; if the value of medical devices illegally produced and operated is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of not less than 5 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, the legal representative, main responsible person, directly responsible supervisor and other responsible personnel of the illegal unit shall have their income obtained from the unit confiscated during the period of the illegal act, and a fine of not less than 30% but not more than 2 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production and business activities for 5 years:

(1) Producing or operating Class I medical devices that have not been recorded;

(2) Engaging in the production of Class I medical devices without filing;

(3) Operating Class II medical devices that should be filed but not recorded;

(4) The information that has been filed does not meet the requirements.

Article 85 Where false information is provided during filing, the department responsible for drug supervision and administration shall announce to the public the name of the filing unit and product, and confiscate the illegal gains and illegal production and operation of medical devices; if the value of medical devices illegally produced and operated is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of not less than 5 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, order the suspension of production and business, confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income earned, and prohibit them from engaging in medical device production and business activities for 10 years.

Article 86 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and confiscate medical devices used in illegal production, operation, and use; if the value of medical devices used in illegal production and operation is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of not less than 5 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, order the suspension of production and business until the original licensing department revokes the medical device registration certificate, medical device production license, and medical device business license, and confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income earned, and prohibit them from engaging in medical device production and business activities for 10 years:

(1) Production, operation, or use of medical devices that do not meet mandatory standards or technical requirements for registered or filed products;

(2) Failure to organize production in accordance with the technical requirements of registered or filed products, or failure to establish a quality management system and maintain effective operation in accordance with the provisions of these Regulations, affecting product safety and effectiveness;

(3) Operating or using medical devices that are expired, invalid, or obsolete without qualification documents, or use medical devices that are not registered in accordance with law;

(4) Refusing to recall medical devices after being ordered by the department in charge of drug supervision and administration, or refusing to stop producing, importing, or operating medical devices after the department in charge of drug supervision and administration orders the cessation or suspension of production, import, or operation;

(5) Entrusting enterprises that do not meet the conditions stipulated in these Regulations to produce medical devices, or failing to manage the production behavior of entrusted production enterprises;

(6) Importing expired, invalid, obsolete and other used medical devices.

Article 87 Where a medical device operating enterprise or user unit has fulfilled its obligations such as purchase inspection as provided for in these Regulations, and has sufficient evidence to prove that the medical device it operates or uses is a medical device under the circumstances specified in Article 81, paragraph 1, Article 84, paragraph 1, and Article 86, paragraphs 1 and 3 of these Regulations, and can truthfully explain the source of purchase, the medical device operated or used by the medical device that does not meet the statutory requirements may be exempted from administrative punishment.

Article 88 In any of the following circumstances, the department responsible for drug supervision and administration shall order corrections and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; if they refuse to make corrections, they shall be fined between 50,000 and 100,000 yuan; If the circumstances are serious, order the suspension of production and business until the original issuing department revokes the medical device production license and medical device business license, and confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 2 times the income obtained, and prohibit them from engaging in medical device production and business activities for 5 years:

(1) Production conditions have changed, no longer meet the requirements of the medical device quality management system, and have not been rectified, stopped or reported in accordance with the provisions of these Regulations;

(2) Medical devices whose production and operation instructions and labels do not comply with the provisions of these Regulations;

(3) Failing to transport or store medical devices in accordance with the requirements of medical device instructions and labels;

(4) Transfer of expired, invalid, obsolete or unqualified medical devices in use.

Article 89 In any of the following circumstances, the department in charge of drug supervision and administration and the competent health department shall order corrections and give warnings in accordance with their respective duties; if they refuse to make corrections, they shall be fined between 10,000 and 100,000 yuan; If the circumstances are serious, order the suspension of production and business until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device business license, and impose a fine of not less than 10,000 yuan but not more than 30,000 yuan on the legal representative, main person in charge, directly responsible supervisor and other responsible personnel of the illegal unit:

(1) Failure to submit the quality management system self-inspection report as required;

(2) Purchasing medical devices from suppliers who do not have legal qualifications;

(3) Medical device business enterprises and users fail to establish and implement a medical device purchase inspection record system in accordance with the provisions of these Regulations;

(4) Enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices fail to establish and implement a sales record system in accordance with the provisions of these Regulations;

(5) Medical device registrants, filers, production and business enterprises, and users fail to carry out adverse event monitoring of medical devices in accordance with the provisions of these Regulations, fail to report adverse events as required, or fail to cooperate with adverse event investigations carried out by medical device adverse event monitoring technical institutions, departments responsible for drug supervision and administration, and health authorities;

(6) Medical device registrants and filers fail to formulate post-market research and risk control plans in accordance with regulations and ensure effective implementation;

(7) Medical device registrants and filers fail to establish and implement product traceability systems in accordance with regulations;

(8) Medical device registrants, filers, and operating enterprises engaged in online sales of medical devices fail to notify the department responsible for drug supervision and administration in accordance with regulations;

(9) For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, the medical device user fails to inspect, inspect, calibrate, maintain, maintain and record them in accordance with the requirements of the product manual, and conduct timely analysis and evaluation to ensure that the medical device is in good condition;

(10) The medical device user fails to properly preserve the original materials of the purchase of Class III medical devices.

Article 90 In any of the following circumstances, the competent health department of the people's government at or above the county level shall order corrections and give a warning; if they refuse to make corrections, they shall be fined between 50,000 and 100,000 yuan; If the circumstances are serious, a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed, and the use of relevant medical devices shall be ordered to be suspended until the practice license is revoked by the original licensing department, and the relevant responsible personnel shall be ordered to suspend their practice activities for not less than 6 months but not more than 1 year in accordance with the law, until the practice certificate of the relevant personnel shall be revoked by the original licensing department, and the legal representative, main responsible person, directly responsible supervisor and other responsible personnel of the illegal unit shall be confiscated from the income obtained from the unit during the period of the illegal act, and 30% of the income obtained from the premises shall be confiscated A fine of less than 3 times the above shall be given in accordance with law:

(1) The reused medical device is not handled by the medical device user in accordance with the provisions of disinfection and management;

(2) Medical device users reuse single-use medical devices, or fail to destroy used single-use medical devices in accordance with regulations;

(3) The medical device user fails to record the information of large medical devices and implantable and interventional medical devices in medical records and other relevant records in accordance with regulations;

(4) The medical device user finds that the medical device used has potential safety hazards and does not immediately stop using it, notifies it for maintenance, or continues to use medical devices that still cannot meet the safety standards after maintenance;

(5) Medical device users use large-scale medical equipment in violation of regulations, which cannot ensure medical quality and safety.

Article 91 Importing medical devices in violation of laws and administrative regulations related to import and export commodity inspection shall be handled by the entry-exit inspection and quarantine authorities in accordance with law.

Article 92 Where an e-commerce platform operator providing services for online trading of medical devices violates the provisions of these Regulations by failing to perform management obligations such as real-name registration of online medical device operators, reviewing licenses, registrations, and filings, stopping and reporting illegal acts, and stopping the provision of online trading platform services, the department responsible for drug supervision and administration shall impose punishment in accordance with the provisions of the E-commerce Law of the People's Republic of China.

Article 93 If a medical device clinical trial institution fails to file a clinical trial to carry out clinical trials, the department responsible for drug supervision and administration shall order the clinical trial to be stopped and corrected. if correction is refused, the clinical trial data shall not be used for product registration and filing, and a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed, and announced to the public; If serious consequences are caused, it shall be prohibited from carrying out clinical trials of relevant professional medical devices within 5 years, and a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed, and the competent health department shall confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income obtained from the illegal unit, and impose a penalty in accordance with law.

If the clinical trial sponsor carries out a clinical trial without filing, the department responsible for drug supervision and administration shall order the clinical trial to stop, impose a fine of not less than 50,000 yuan but not more than 100,000 yuan on the clinical trial sponsor, and announce it to the public; if serious consequences are caused, a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed. The clinical trial data shall not be used for product registration and filing, and the application for medical device registration submitted by relevant responsible persons and units will not be accepted within 5 years.

If the clinical trial sponsor carries out clinical trials of Class III medical devices with higher risks to the human body without approval, the department responsible for drug supervision and administration shall order the clinical trial to be stopped immediately, impose a fine of not less than 100,000 yuan but not more than 300,000 yuan on the clinical trial sponsor, and announce it to the public; if serious consequences are caused, a fine of not less than 300,000 yuan but not more than 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration, and the application for clinical trial and registration of medical devices submitted by relevant responsible persons and units shall not be accepted within 10 years, and the legal representatives, main responsible persons, directly responsible supervisors and other responsible personnel of the illegal unit shall be confiscated from the income obtained from the unit during the period of the illegal act, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed.

Article 94 Where a medical device clinical trial institution conducts clinical trials of medical devices and fails to comply with the clinical trial quality management specifications, the department responsible for drug supervision and administration shall order corrections or immediately stop clinical trials, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; If serious consequences are caused, it is prohibited to carry out clinical trials of relevant professional medical devices within 5 years, and the competent health department shall confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income obtained from the illegal unit, and impose a penalty in accordance with the law.

Article 95 Where a medical device clinical trial institution issues a false report, the department responsible for drug supervision and administration shall impose a fine of not less than 100,000 yuan but not more than 300,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; prohibit them from carrying out clinical trials of related professional medical devices within 10 years; The competent health department shall confiscate the income obtained from the unit during the period of the illegal act, and impose a fine of not less than 30% but not more than 3 times the income obtained from the illegal unit, and impose a penalty in accordance with law.

Article 96 If a medical device inspection institution issues a false inspection report, the competent department that granted it shall revoke the inspection qualification, and will not accept the application for qualification recognition submitted by the relevant responsible person and unit within 10 years, and shall be fined between 100,000 and 300,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; The legal representatives, principal responsible persons, directly responsible managers, and other responsible personnel of the illegal unit shall have their income obtained from the unit confiscated during the period of the illegal act, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed in accordance with law; those who are dismissed shall be prohibited from engaging in medical device inspection for 10 years.

Article 97 Those who violate the provisions of these Regulations on the management of medical device advertising shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China.

Article 98 Where a legal person of an enterprise in our country designated by the registrant or filer of an overseas medical device fails to perform relevant obligations in accordance with the provisions of these Regulations, the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order corrections, give a warning, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the circumstances are serious, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed, and their legal representatives, main responsible persons, directly responsible supervisors and other responsible personnel shall be prohibited from engaging in medical device production and business activities within 5 years.

If the overseas medical device registrant or filer refuses to perform the administrative penalty decision made in accordance with these Regulations, the import of the medical device shall be prohibited for 10 years.

Article 99 Where medical device development, production, and business units and inspection institutions use personnel prohibited from engaging in medical device production and business activities or inspection work in violation of these Regulations, the department responsible for drug supervision and administration shall order corrections and give warnings; if they refuse to make corrections, they shall be ordered to suspend production and business until the license is revoked.

Article 100 Where medical device technical review institutions or medical device adverse event monitoring technical institutions fail to perform their duties in accordance with the provisions of these Regulations, resulting in major mistakes in the review and monitoring work, the department responsible for drug supervision and administration shall order corrections, notify criticism, and give warnings; Where serious consequences are caused, the legal representative, principal responsible person, directly responsible manager, and other responsible personnel of the illegal unit shall be punished in accordance with law.

Article 101 Personnel of the department responsible for drug supervision and administration or other relevant departments who violate the provisions of these Regulations by abusing their powers, neglecting their duties, or engaging in corruption for personal gain shall be punished in accordance with law.

Article 102: Where the provisions of these Regulations are violated and constitute a crime, criminal responsibility shall be pursued in accordance with law; If it causes damages to persons, property or other people, it shall be liable for compensation in accordance with law.

Chapter VIII Supplementary Provisions

Article 103 The meaning of the following terms in these Regulations:

Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials and other similar or related items directly or indirectly used in the human body, including computer software required; Its utility is mainly obtained through physical and other means, not through pharmacology, immunology or metabolism, or although these methods are involved, it only plays an auxiliary role. Its purpose is:

(1) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;

(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injuries;

(3) Testing, replacement, regulation, or support of physiological structures or processes;

(4) Life support or maintenance;

(5) Pregnancy control;

(6) Provide information for medical or diagnostic purposes by examining samples from the human body.

Medical device registrants and filers refer to enterprises or research and development institutions that have obtained medical device registration certificates or handled medical device filings.

Medical device users refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, blood stations, apheresis stations, rehabilitation aid adaptation institutions, etc.

Large-scale medical equipment refers to large-scale medical devices with complex technology, large capital investment, high operating costs, great impact on medical expenses, and included in the catalogue management.

Article 104 Fees may be charged for the registration of medical device products. The specific charging items and standards shall be formulated by the finance and price authorities of the State Council in accordance with relevant national regulations.

Article 105 The administrative measures for medical devices developed by medical and health institutions in response to public health emergencies shall be formulated by the drug administration department of the State Council in conjunction with the competent health department of the State Council.

The storage, allocation, and supply of non-profit contraceptive medical devices shall comply with the management measures formulated by the competent health department of the State Council in conjunction with the drug administration department of the State Council.

The technical guiding principles for traditional Chinese medicine medical devices shall be formulated by the drug administration department of the State Council in conjunction with the traditional Chinese medicine administration department of the State Council.

Article 106 The supervision and management of the use of military medical devices shall be implemented in accordance with these Regulations and relevant military provisions.

Article 107 These Regulations shall come into force on June 1, 2021.