The Regulations on the Supervision and Administration of Medical Devices have been revised and passed at the 119th Executive Meeting of the State Council on December 21, 2020, and are hereby promulgated. They will come into effect on June 1, 2021.

Premier Li Keqiang

February 9, 2021

Regulations on the Supervision and Administration of Medical Devices

(Promulgated by Order No. 276 of the State Council of the People's Republic of China on January 4, 2000, revised and approved at the 39th executive meeting of the State Council on February 12, 2014. Revised and approved at the 119th executive meeting of the State Council on December 21, 2020 based on the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017.)

Chapter 1 General Provisions

Article 1: In order to ensure the safety and effectiveness of medical devices, safeguard human health and life safety, and promote the development of the medical device industry, this regulation is formulated.

Article 2: 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, shall be governed by these Regulations.

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

The relevant departments of the State Council are responsible for the supervision and management of medical devices within their respective responsibilities.

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 and emergency response work within their respective administrative regions, strengthen the construction of medical device supervision and management capabilities, and provide guarantees for the safety of medical devices.

The departments responsible for drug supervision and management of local people's governments at or above the county level are 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 their respective responsibilities.

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

Article 6: The state implements classified management of medical devices according to their degree of risk.

The first type is medical devices with a low level of risk, and implementing routine management can ensure their safety and effectiveness.

The second type is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness.

The third category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.

When evaluating the risk level of medical devices, factors such as the expected purpose, structural characteristics, and usage methods of the medical device should be considered.

The drug regulatory department of the State Council is responsible for formulating classification rules and catalogs for medical devices, and timely analyzing and evaluating the risk changes of medical devices based on their production, operation, and use, and adjusting the classification rules and catalogs. When formulating and adjusting classification rules and catalogs, it is necessary to fully listen to the opinions of medical device registrants, recorders, production and operation enterprises, user units, and industry organizations, and refer to international medical device classification practices. The classification rules and catalog of medical devices shall be made public to the society.

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

Article 8: The state shall formulate plans and policies for the medical device industry, incorporate medical device innovation into the development focus, prioritize the evaluation and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote 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 to implement the national medical device industry plan and guidance policies.

Article 9: The state shall improve the innovation system of medical devices, support basic and applied research of medical devices, promote the promotion and application of new technologies in medical devices, and provide support in technology project approval, financing, credit, bidding procurement, medical insurance, and other aspects. Support enterprises to establish or jointly establish research and development institutions, encourage cooperation between enterprises and universities, 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 independent innovation ability of medical devices.

Article 10: The state strengthens the informatization construction of medical device supervision and management, improves the level of online government services, and provides convenience for medical device administrative licensing, filing, etc.

Article 11: Medical device industry organizations shall strengthen industry self-discipline, promote the construction of an integrity system, supervise 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 in the research and innovation of medical devices shall be commended and rewarded in accordance with relevant national regulations.

Chapter 2 Registration and Filing of Medical Device Products

Article 13: The first category of medical devices shall be subject to product registration management, while the second and third categories of medical devices shall be subject to product registration management.

Medical device registrants and registrants shall strengthen the quality management of the entire life cycle of medical devices, and bear responsibility for the safety and effectiveness of traditional Chinese medicine medical devices throughout the development, production, operation, and use process in accordance with the law.

Article 14: For the registration of Class I medical device products and for the registration of Class II and Class III medical device products, the following documents shall be submitted:

（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 should comply with the requirements of the drug regulatory department of the State Council. It can be a self inspection report of the medical device registration applicant or the registrant, or an inspection report issued by a qualified medical device inspection institution entrusted.

Those who comply with Article 24 of these Regulations and are exempt from clinical evaluation may be exempted from submitting clinical evaluation materials.

Medical device registration applicants and registrants should ensure that the submitted materials are legal, true, accurate, complete, and traceable.

Article 15: For the registration of Class I medical device products, the registrant shall submit the registration materials to the department responsible for drug supervision and management of the municipal people's government in the district where the registrant is located.

For overseas registrants who export Class I medical devices to China, their designated domestic enterprise legal representative shall submit the registration materials and proof of approval from the competent authorities of the country (region) where the registrant is located for the marketing and sales of the medical device to the drug regulatory department of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit proof documents from the competent authorities of the country (region) where the registrant is located that allow the medical device to be listed for sale.

The registrant shall complete the filing upon submitting the filing materials that comply with the provisions of this Regulation to the department responsible for drug supervision and management. The department responsible for drug supervision and management shall, within 5 working days from the date of receiving the filing materials, disclose the relevant information to the society through the online government service platform of the State Council's drug supervision and management department.

If there is a change in the items stated in the filing materials, the original filing department shall be notified of the change in filing.

Article 16: To apply for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the local province, autonomous region, or municipality directly under the central government. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the drug regulatory department of the State Council.

For overseas registration applicants who export Class II and Class III medical devices to China, their designated domestic enterprise legal representative shall submit registration application materials and proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be sold on the market to the drug regulatory department of the State Council. Innovative medical devices that have not been listed overseas may not be required to submit proof documents from the competent authorities of the country (region) where the registration applicant is located that allow the medical device to be listed for sale.

The drug regulatory department of the State Council shall formulate regulations on the procedures and requirements for the registration and review of medical devices, and strengthen supervision and guidance on the registration and review work 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 that accepts registration applications shall review the safety and effectiveness of medical devices, as well as the registration applicant's ability to ensure the safety and effective quality management of medical devices.

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

If the drug regulatory department that accepts the registration application deems it necessary to verify the quality management system during the technical evaluation of medical devices, it shall organize quality management system verification.

Article 18: The drug regulatory department that accepts registration applications shall make a decision within 20 working days from the date of receiving the evaluation opinions. For those who meet the conditions, registration is granted and a medical device registration certificate is issued; Those who do not meet the conditions shall not be registered and their reasons shall be explained in writing.

The drug regulatory department that accepts registration applications shall, within 5 working days from the date of approval for registration of medical devices, disclose relevant registration information to the public through the online government service platform of the State Council's drug regulatory department.

Article 19: For medical devices used for the treatment of rare diseases, serious life-threatening diseases without effective treatment methods, and urgently needed in response to public health events, the drug regulatory department that accepts registration applications may make conditional approval decisions and specify relevant matters in the medical device registration certificate.

In the event of a particularly significant public health emergency or other serious threat to public health, the competent health department of the State Council shall propose suggestions for the emergency use of medical devices based on the needs of prevention and control of the event. After the organization and approval of the drug regulatory department of the State Council, emergency use of medical devices can be carried out within a certain range and period.

Article 20: Medical device registrants and registrants shall fulfill the following obligations:

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

（2） Develop a post market research and risk management plan and ensure 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 drug regulatory department of the State Council.

The domestic enterprise legal person designated by the overseas medical device registrant and registrant in China shall assist the registrant and registrant in fulfilling the obligations specified in the preceding paragraph.

Article 21: If there are substantial changes in the design, raw materials, production process, scope of application, and methods of use of registered Class II and Class III medical device products that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department to handle the registration change procedures; If other changes occur, they shall be filed or reported in accordance with the regulations of the drug regulatory department of the State Council.

Article 22: The validity period of the medical device registration certificate is 5 years. If the registration needs to be renewed after the expiration of the validity period, an application for renewal of registration should be submitted to the original registration department 6 months before the expiration of the validity period.

Except for the circumstances specified in the third paragraph of this article, the drug regulatory department that receives 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 a decision is not made within the prescribed time limit, it shall be deemed that the extension is granted.

If one of the following situations occurs, 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 medical devices applying for registration extension cannot meet the new requirements;

（3） Medical devices approved with conditions have not completed the items specified in the medical device registration certificate within the specified period.

Article 23: For newly developed medical devices that have not been included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of this Regulation on the registration of Class III medical device products, or determine the product category based on the classification rules and apply to the drug regulatory department of the State Council for category confirmation before applying for product registration or filing in accordance with the provisions of this Regulation.

For those who directly apply for the registration of Class III medical device products, the drug regulatory department of the State Council shall determine the category based on the degree of risk, and promptly include the approved medical devices in the classification catalog. If the application category is confirmed, the drug regulatory department of the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of the medical device and notify the applicant.

Article 24: The registration and filing of medical device products shall undergo clinical evaluation; However, if one of the following conditions is met, clinical evaluation can be exempted:

（1） The working mechanism is clear, the design is standardized, the production process is mature, and the same type of medical device has been clinically applied for many years without serious adverse event records, without changing its conventional use;

（2） Other non clinical evaluations can demonstrate the safety and effectiveness of the medical device.

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

Article 25: Clinical evaluation of medical devices may be conducted based on product characteristics, clinical risks, existing clinical data, etc., by conducting clinical trials, or by analyzing and evaluating clinical literature and data of the same variety of medical devices, to prove the safety and effectiveness of medical devices.

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

Article 26: Clinical trials of medical devices shall be conducted in accordance with the requirements of the quality management standards for clinical trials of medical devices, in clinical trial institutions with corresponding conditions, and shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality where the clinical trial applicant is located. The drug regulatory department that accepts clinical trial registration shall report the registration situation to the drug regulatory department and health regulatory department at the same level in the location of the clinical trial institution.

Medical device clinical trial institutions implement record keeping management. The conditions that medical device clinical trial institutions should possess, as well as the filing management measures and clinical trial quality management standards, shall be formulated and announced by the drug regulatory department of the State Council in conjunction with the health regulatory department of the State Council.

The state supports medical institutions in conducting clinical trials, including the evaluation of clinical trial conditions and capabilities in the level evaluation of medical institutions, and encourages medical institutions to carry out innovative medical device clinical trials.

Article 27: Clinical trials of Class III medical devices that pose a high risk to the human body shall be approved by the drug regulatory department of the State Council. The drug regulatory department of the State Council shall conduct a comprehensive analysis of the equipment, professional personnel, and other conditions of the institution intended to undertake clinical trials of medical devices, the risk level of the medical device, the clinical trial implementation plan, and the comparative analysis report of clinical benefits and risks. The decision shall be made and the clinical trial applicant shall be notified within 60 working days from the date of acceptance of the application. If no notice is given within the time limit, it shall be deemed as consent. If clinical trials are allowed, they shall be notified to the drug regulatory department and the health regulatory department of the people's government of the province, autonomous region, or municipality directly under the central government where the clinical trial institution is 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 regulatory department of the State Council.

Article 28: When conducting clinical trials of medical devices, ethical review shall be conducted in accordance with regulations, and detailed information such as the purpose, purpose, and potential risks of the trial shall be informed to the subjects, and written informed consent shall be obtained from the subjects; If the subject is a person without or with limited civil capacity, they shall obtain written informed consent from their guardian in accordance with the law.

Clinical trials shall not be conducted and fees related to clinical trials shall not be charged to subjects in any form.

Article 29: Medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatment methods may benefit patients through medical observation. After ethical review and informed consent, they can be used free of charge for other patients with similar conditions in institutions conducting clinical trials of medical devices. Their safety data can be used for medical device registration applications.

Chapter 3 Medical Device Production

Article 30: To engage in the production of medical devices, the following conditions shall be met:

（1） Having a production site, environmental conditions, production equipment, and professional technical personnel suitable for the production of medical devices;

（2） Having institutions or dedicated inspectors and inspection equipment capable of conducting quality inspections on medical devices produced;

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

（4） Having the ability to provide after-sales service that is suitable for the medical devices produced;

（5） Meet the requirements specified in product development and production process documents.

Article 31: Those engaged in the production of Class I medical devices shall file a record with the department responsible for drug supervision and management of the municipal people's government in the district where they are located. The record shall be completed after submitting relevant materials that meet the conditions specified in Article 30 of these Regulations.

If the medical device registrant produces the first type of medical device on their own, they may submit relevant materials that meet the conditions specified in Article 30 of this Regulation when filing the product in accordance with Article 15 of this Regulation, and complete the production filing.

Article 32: Those engaged in the production of Class II and Class III medical devices shall apply for a production license from the drug regulatory 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, as well as the registration certificate of the medical devices produced.

The drug regulatory department that accepts production license applications shall review the application materials, verify them in accordance with the requirements of the quality management standards for medical device production 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. For those who meet the prescribed conditions, a license shall be granted and a medical device production license shall be issued; For those who do not meet the prescribed conditions, no permission shall be granted and written reasons shall be provided.

The validity period of the medical device production license is 5 years. If the validity period needs to be extended upon expiration, the extension procedures shall be handled in accordance with the relevant laws and regulations on administrative licensing.

Article 33: The quality management standards for medical device production shall clearly stipulate the design and development of medical devices, production equipment conditions, raw material procurement, production process control, product release, organizational structure and personnel allocation of enterprises, and other matters that affect the safety and effectiveness of medical devices.

Article 34: Medical device registrants and registrants may produce medical devices themselves, or entrust enterprises that meet the provisions of these regulations and meet corresponding conditions to produce medical devices.

If a medical device is commissioned for production, the medical device registrant and registrant shall be responsible for the quality of the medical device commissioned for production, and strengthen the management of the production behavior of the commissioned production enterprise to ensure that it produces in accordance with legal requirements. The medical device registrant and registrant shall sign a commission 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 and regulations, medical device production quality management standards, mandatory standards, product technical requirements, and commission agreements, be responsible for production behavior, and accept supervision from the commissioning party.

Implantable medical devices with high risks shall not be commissioned for production, and the specific catalog shall be formulated, adjusted, and published by the drug regulatory department of the State Council.

Article 35: Medical device registrants, recorders, and entrusted production enterprises shall establish and improve a quality management system suitable for the medical devices they produce in accordance with the quality management standards for medical device production, and ensure their effective operation; Strictly organize production in accordance with the registered or registered product technical requirements, ensuring that the medical devices manufactured meet mandatory standards and the registered or registered product technical requirements.

Medical device registrants, recorders, 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 regulations of the drug regulatory department of 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, registrant, and entrusted production enterprise shall immediately take corrective measures; If it may affect the safety and effectiveness of medical devices, production activities should be immediately stopped and reported to the original production license or production filing department.

Article 37 Medical devices shall use a common name. The universal name shall comply with the naming rules for medical devices formulated by the drug regulatory department of the State Council.

Article 38: The state shall implement a unique identification system for medical devices step by step based on the category of medical device products, to achieve traceability of medical devices. The specific measures shall be formulated by the drug regulatory department of the State Council in conjunction with relevant departments of the State Council.

Article 39 Medical devices shall have instructions and labels. The content of the instruction manual and label should be consistent with the relevant content registered or filed, ensuring authenticity and accuracy.

The instructions and labels of medical devices should indicate the following:

（1） Common name, model, and specification;

（2） The names, addresses, and contact information of the medical device registrant, registrant, and entrusted production enterprise;

（3） Production date, service life or expiration date;

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

（5） Taboos, precautions, and other contents that require warning or reminder;

（6） Installation and usage instructions or illustrations;

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

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

The second and third categories of medical devices should also indicate the medical device registration certificate number.

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

Chapter 4 Operation and Use of Medical Devices

Article 40: To engage in the business activities of medical devices, there shall be a business premises and storage conditions that are suitable for the scale and scope of business, as well as a quality management system and quality management institutions or personnel that are suitable for the medical devices being operated.

Article 41: For those engaged in the operation of Class II medical devices, the operating enterprise shall file a record with the department responsible for drug supervision and management of the municipal people's government with districts in its location and submit relevant materials that meet the conditions specified in Article 40 of these Regulations.

According to the regulations of the drug regulatory 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 registration.

Article 42: For those engaged in the operation of Class III medical devices, the operating enterprise shall apply for a business license to the department responsible for drug supervision and management of the municipal people's government with districts in its location, and submit relevant materials that meet the conditions specified in Article 40 of these Regulations.

The department responsible for drug supervision and management that accepts business license applications 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. For those who meet the prescribed conditions, a license shall be granted and a medical device business license shall be issued; For those who do not meet the prescribed conditions, no permission shall be granted and written reasons shall be provided.

The validity period of the medical device operation license is 5 years. If the validity period needs to be extended upon expiration, the extension procedures shall be handled in accordance with the relevant laws and regulations on administrative licensing.

Article 43: Medical device registrants and registrants who operate their registered and registered medical devices do not need to apply for a medical device business license or registration, but must meet the operating conditions stipulated in these regulations.

Article 44: Engaging in the business of medical devices shall establish and improve a quality management system that is suitable for the medical devices they operate and ensure their effective operation in accordance with the requirements of laws and regulations and the quality management standards for medical device business formulated by the drug regulatory department of the State Council.

Article 45 Medical device operating enterprises and user units shall purchase medical devices from legally qualified medical device registrants, recorders, and production and operation enterprises. When purchasing medical devices, the qualification of the supplier and the qualification certificate of the medical device should be checked, and a purchase inspection record system should be established. Enterprises engaged in the wholesale business of Class II and Class III medical devices, as well as the retail business of Class III medical devices, should also establish a sales record system.

The recorded items include:

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

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

（3） The names of the medical device registrant, registrant, and entrusted production enterprise;

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

（5） Number of relevant license certification documents, etc.

The purchase inspection records and sales records shall be true, accurate, complete, and traceable, and shall be kept within the period specified by the drug regulatory department of the State Council. The state encourages the use of advanced technological means for recording.

Article 46: Those engaged in online sales of medical devices shall be medical device registrants, recorders, or medical device operating enterprises. Operators engaged in online sales of medical devices shall inform the relevant information of online sales of medical devices to the drug supervision and management department of the municipal people's government in the district where they are located, except for those engaged in the operation of Class I medical devices and Class II medical devices as stipulated in Article 41 (2) of these Regulations.

E-commerce platform operators providing services for online transactions of medical devices should register with their real names, review their business licenses, filing status, and registration and filing status of the medical device products they operate, and manage their business activities. If e-commerce platform operators discover that online medical device operators have violated the provisions of these regulations, they shall promptly stop and immediately report to the drug supervision and management department of the municipal people's government in the district where the medical device operators are located; If serious illegal activities are discovered, the provision of online trading platform services should be immediately stopped.

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

Article 48: Medical device users shall have storage places and conditions suitable for the types and quantities of medical devices in use. Medical device users should strengthen technical training for their staff and use medical devices in accordance with product manuals, technical operating standards, and other requirements.

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

The management measures for the configuration of large-scale medical equipment shall be formulated by the competent health department of the State Council in conjunction with relevant departments of the State Council. The catalog of large-scale medical equipment shall be proposed by the competent health department of the State Council in consultation with relevant departments of the State Council, and shall be implemented after being approved by the State Council.

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

Disposable medical devices shall not be reused, and those that have been used shall be destroyed and recorded in accordance with relevant national regulations. The list of disposable medical devices shall be formulated, adjusted, and published by the drug regulatory department of the State Council in conjunction with the health regulatory department of the State Council. Listed in the list of disposable medical devices, there should be sufficient evidence to prove that they cannot be reused. Reuse can ensure safe and effective medical devices, and is not included in the list of disposable medical devices. For medical devices that can be reused safely and effectively due to improvements in design, production process, disinfection and sterilization technology, a list of disposable medical devices should be adjusted to allow for reuse.

Article 50: Medical device users shall inspect, inspect, calibrate, maintain, and record medical devices that require regular inspection, calibration, upkeep, and maintenance in accordance with the requirements of the product manual. They shall analyze and evaluate them in a timely manner 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 records should be established one by one, recording their use, maintenance, transfer, actual usage time, and other matters. The record retention period shall not be less than 5 years after the expiration of the prescribed use period of the medical device.

Article 51: Medical device users shall properly preserve the original materials of purchased Class III medical devices and ensure the traceability of the information.

For the use of large medical devices and implanted and interventional medical devices, the name, key technical parameters, and necessary information closely related to the quality and safety of the medical device should be recorded in relevant records such as medical records.

Article 52: If safety hazards are found in the medical devices used, the medical device user unit shall immediately stop using them and notify the medical device registrant, registrant, or other institutions responsible for product quality to conduct maintenance; Medical devices that cannot meet the safety standards for use after maintenance shall not continue to be used.

Article 53: For in vitro diagnostic reagents that have not yet been marketed in the same variety in China, medical institutions that meet the conditions may develop them themselves according to the clinical needs of their own units and use them within their own units under the guidance of licensed physicians. The specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the competent health department of the State Council.

Article 54: The department responsible for drug supervision and management and the health regulatory department shall, in accordance with their respective responsibilities, supervise and manage the quality of medical devices and the use of medical devices in the use process.

Article 55 Medical device operating enterprises and user units shall not operate or use medical devices that have not been registered or filed in accordance with the law, have no qualification certificates, or have expired, expired, or eliminated.

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, expired, eliminated, or unqualified medical devices.

Article 57: Imported medical devices shall be registered or filed in accordance with the provisions of Chapter 2 of these Regulations.

Imported medical devices should have Chinese instructions and labels. The instructions and labels shall comply with the provisions of this Regulation and relevant mandatory standards, and shall specify the origin of the medical device and the name, address, and contact information of the domestic enterprise legal person designated by the overseas medical device registrant and registrant in China. If there is no Chinese instruction manual or 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 urgently need to import a small amount of Class II and Class III medical devices due to clinical needs may import them with the approval of the drug regulatory department of the State Council or the people's governments of provinces, autonomous regions, and municipalities authorized by the State Council. Imported medical devices should be used for specific medical purposes within designated medical institutions.

Prohibit the import of expired, expired, and obsolete medical devices that have already been used.

Article 58: Entry exit inspection and quarantine institutions shall conduct inspections on imported medical devices in accordance with the law; Those that fail the inspection shall not be imported.

The drug regulatory department of the State Council shall promptly report the registration and filing status of imported medical devices to the national entry-exit inspection and quarantine department. The entry and exit inspection and quarantine institution of the place where the import port is located shall promptly report the customs clearance status of imported medical devices to the department responsible for drug supervision and management of the municipal people's government with districts in the place where the import port is located.

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, and shall be based on the medical device instructions registered or filed with the department responsible for drug supervision and management. They shall not contain false, exaggerated, or misleading content.

Before publishing medical device advertisements, the advertising review agency determined by the people's government of the province, autonomous region, or municipality directly under the Central Government shall review the advertising content and obtain the approval number for medical device advertisements; Without review, it shall not be released.

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

The examination methods for medical device advertisements shall be formulated by the market supervision and management department of 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, and timely collect, analyze, evaluate, and control adverse events of medical devices.

Article 62: Medical device registrants and registrants shall establish a medical device adverse event monitoring system, equipped with adverse event monitoring institutions and personnel suitable for their products, actively carry out adverse event monitoring on their products, and report 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 drug regulatory department of the State Council.

Medical device production and operation enterprises and user units shall assist medical device registrants and recorders in conducting adverse event monitoring of the 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 regulations of the drug regulatory department of the State Council.

Other units and individuals who discover adverse events or suspected adverse events of medical devices have the right to report to the department responsible for drug supervision and management or the technical institution for monitoring adverse events of medical devices.

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

Medical device adverse event monitoring technology institutions should strengthen the monitoring of medical device adverse event information and actively collect adverse event information; If an adverse event is discovered or reported, it should be promptly verified, and if necessary, investigated, analyzed, and evaluated. It should be reported to the department responsible for drug supervision and management and the health regulatory department, and suggestions for handling should be proposed.

Medical device adverse event monitoring technology institutions should disclose their contact information to facilitate the reporting of medical device adverse events by medical device registrants, recorders, production and operation enterprises, user units, etc.

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

The drug regulatory department of the people's government at or above the provincial level shall, in conjunction with the same level of health regulatory departments and relevant departments, promptly investigate and handle adverse events of medical devices that cause sudden or mass serious injuries or deaths, and organize strengthened monitoring of similar medical devices.

The department responsible for drug supervision and management shall promptly report the adverse event monitoring of medical device users to the same level of health regulatory authorities.

Article 65: Medical device registrants, recorders, production and operation enterprises, and user units shall cooperate with medical device adverse event monitoring technical institutions, departments responsible for drug supervision and management, and health regulatory departments in conducting medical device adverse event investigations.

Article 66: In any of the following circumstances, the medical device registrant or registrant shall actively conduct a re evaluation of listed medical devices:

（1） Changes in understanding of the safety and effectiveness of medical devices based on the development of scientific research;

（2） The monitoring and evaluation results of adverse events of medical devices indicate that there may be defects in the medical devices;

（3） Other situations stipulated by the drug regulatory department of the State Council.

The registrant and registrant of medical devices shall take corresponding control measures based on the re evaluation results, improve the listed medical devices, and make registration or registration changes in accordance with regulations. If the re evaluation results indicate that the listed medical devices cannot guarantee safety and effectiveness, the medical device registrant or registrant shall actively apply for the cancellation of the medical device registration certificate or cancellation of the registration; If the medical device registrant or registrant has not applied for the cancellation of the medical device registration certificate or the cancellation of the registration, the department responsible for drug supervision and management shall cancel the medical device registration certificate or cancel the registration.

The drug supervision and management department of the people's government at or above the provincial level shall conduct re evaluation of listed medical devices based on the monitoring and evaluation of adverse events of medical devices. If the re evaluation results indicate that the listed medical devices cannot guarantee safety and effectiveness, the medical device registration certificate should be cancelled or the record should be cancelled.

The department responsible for drug supervision and management shall promptly disclose the cancellation of medical device registration certificates and record cancellations to the society. Medical devices whose registration certificate has been cancelled or whose registration has been cancelled shall not continue to be produced, imported, operated or used.

Article 67: If a medical device registrant or registrant discovers that the medical device produced does not meet mandatory standards, registered or registered product technical requirements, or has other defects, they shall immediately stop production, notify relevant operating enterprises, user units, and consumers to stop operating and using, recall medical devices that have already been listed for sale, take remedial, destruction, and other measures, record relevant situations, and publish relevant information, And report the recall and handling of medical devices to the department responsible for drug supervision and management and the health regulatory department.

If the entrusted production or operation enterprise of medical devices discovers that the production or operation of medical devices falls under the circumstances specified in the preceding paragraph, it shall immediately stop production or operation, notify the medical device registrant and registrant, and record the cessation of production, operation, and notification. If the medical device registrant or registrant believes that a medical device needs to be recalled in accordance with the provisions of the preceding paragraph, it shall be immediately recalled.

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

Chapter 6 Supervision and Inspection

Article 68: The state shall establish a system of professional and specialized inspectors to strengthen the supervision and inspection of medical devices.

Article 69: The department responsible for drug supervision and management 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 the production is organized in accordance with the registered or registered product technical requirements;

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

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

When necessary, the department responsible for drug supervision and management may conduct extended inspections on other relevant units and individuals who provide products or services for the development, production, operation, and use of medical devices.

Article 70: The department responsible for drug supervision and management shall have the following powers in supervision and inspection:

（1） Entering the site for inspection and sampling;

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

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

（4） Seal up places that engage in medical device production and operation activities in violation of the provisions of these regulations.

When conducting supervision and inspection, law enforcement documents should be presented and the business secrets of the inspected unit should 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 them.

Article 71: The competent health authorities shall strengthen supervision and inspection of the use of medical devices by medical institutions. When conducting supervision and inspection, one can enter medical institutions to access and copy relevant files, records, and other relevant materials.

Article 72: If there are potential quality and safety hazards in the production and operation of medical devices that have not been eliminated in a timely manner, the department responsible for drug supervision and management may take measures such as warning, responsibility interview, and ordering rectification within a specified period.

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 management may take emergency control measures to order the suspension of production, import, operation, and use, and issue safety warning information.

Article 73: The department responsible for drug supervision and management shall strengthen the random inspection and inspection of medical devices produced, operated, and used by medical device registrants, recorders, production and operation enterprises, and user units. Random inspection and inspection shall not charge inspection fees or any other fees, and the required fees shall be included in the budget of the local government. The drug supervision and management departments of the people's governments at or above the provincial level shall promptly issue medical device quality announcements based on the conclusions of random inspections and inspections.

The health regulatory department shall supervise and evaluate the use of large medical equipment; Those who discover illegal use or excessive examination or treatment related to large medical equipment should be immediately corrected and dealt with in accordance with the law.

Article 74: If the department responsible for drug supervision and management fails to timely identify systemic risks to the safety of medical devices or eliminate potential safety hazards of medical devices within the supervision and management area, the people's government at the same level or the department responsible for drug supervision and management at a higher level shall hold an interview with its main responsible person.

If the local people's government fails to fulfill its medical device safety responsibilities and timely eliminate major regional medical device safety hazards, the higher-level people's government or the department responsible for drug supervision and management of the higher-level people's government shall conduct interviews with their main responsible persons.

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

Article 75: The qualification certification of medical device inspection institutions shall be subject to unified management in accordance with relevant national regulations. Only inspection institutions recognized by the State Council's certification and recognition regulatory department in conjunction with the State Council's drug regulatory department can conduct inspections on medical devices.

If the department responsible for drug supervision and management needs to inspect medical devices in law enforcement work, it shall entrust qualified medical device inspection institutions to do so and pay relevant fees.

If the parties concerned have objections to the inspection conclusion, they may, within 7 working days from the date of receiving the inspection conclusion, submit a re inspection application to the department implementing the sampling inspection or its higher-level department responsible for drug supervision and management. The department accepting the re inspection application shall randomly select a re inspection institution from the list of re inspection institutions for re inspection. The medical device inspection institution responsible for 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 institution and the initial inspection institution shall not be the same institution; If there is only one qualified inspection institution for the relevant inspection items, the responsible department or personnel should be changed during the re inspection. The list of re inspection institutions shall be announced by the drug regulatory department of the State Council.

Article 76: For medical devices that may contain harmful substances or have unauthorized changes in the design, raw materials, and production processes of medical devices and pose safety hazards, if the inspection items and methods specified in the national and industry standards for medical devices cannot be conducted, the medical device inspection institution may use supplementary inspection items and methods approved by the drug regulatory department of the State Council for inspection; The inspection conclusions obtained by using supplementary inspection items and methods can serve as the basis for the department responsible for drug supervision and management to determine the quality of medical devices.

Article 77: Market supervision and management departments shall supervise and inspect medical device advertisements in accordance with the provisions of relevant laws and administrative regulations on advertising management, and investigate and punish illegal acts.

Article 78: The department responsible for drug supervision and management shall, through the online government service platform of the State Council's drug supervision and management department, promptly disclose daily supervision and management information such as medical device licensing, filing, random inspection, and investigation and punishment of illegal acts in accordance with the law. However, it is not allowed to disclose the trade secrets of the parties involved.

The department responsible for drug supervision and management shall establish credit records for medical device registrants, recorders, production and operation enterprises, and user units, increase the frequency of supervision and inspection for those with bad credit records, and strengthen punishment for dishonesty in accordance with the law.

Article 79: Departments responsible for drug supervision and management shall disclose their contact information and accept inquiries, complaints, and reports. Departments responsible for drug supervision and management shall promptly respond to inquiries related to medical device supervision and management; Upon receiving complaints or reports, they shall promptly verify, handle, and respond. Consultation, complaints, and reports, as well as their responses, verifications, and handling situations, should be recorded and preserved.

If a report on the development, production, operation, or use of medical devices is found to be true after investigation, the department responsible for drug supervision and management shall reward the reporter. The relevant departments should keep the informant confidential.

Article 80: The drug regulatory department of the State Council shall publicly solicit opinions on the formulation, adjustment, and modification of the catalogs and standards related to the supervision and management of medical devices stipulated in these Regulations; Adopt forms such as hearings and argumentation meetings to listen to opinions from experts, medical device registrants, registrants, production and operation enterprises, users, consumers, industry associations, and relevant organizations.

Chapter 7 Legal Liability

Article 81: In any of the following circumstances, the department responsible for drug supervision and management shall confiscate the illegal gains, medical devices produced and operated illegally, and tools, equipment, raw materials and other items used for illegal production and operation; If the value of medical devices produced and operated illegally is less than 10000 yuan, a fine of not less than 50000 yuan but not more than 150000 yuan shall be imposed; If the value of the goods exceeds 10000 yuan, a fine of 15 to 30 times the value of the goods shall also be imposed; If the circumstances are serious, the violator shall be ordered to suspend production and business. Within 10 years, the relevant responsible person and the medical device license application submitted by the unit shall not be accepted. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income earned from the unit during the illegal act, and a fine of 30% to 3 times the income earned shall be imposed. They shall be prohibited from engaging in medical device production and business activities for life:

（1） Production and operation of Class II and Class III medical devices without obtaining 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 the circumstances mentioned in the first paragraph of the preceding paragraph are serious, the original issuing department shall revoke the medical device production license or medical device business license.

Article 82: If large-scale medical equipment is configured and used without permission, the competent health department of the people's government at or above the county level shall order it to stop using, issue a warning, and confiscate its illegal gains; If the illegal gains are less than 10000 yuan, a fine of not less than 50000 yuan but not more than 100000 yuan shall be imposed; If the illegal gains exceed 10000 yuan, a fine of 10 to 30 times the illegal gains shall also be imposed; If the circumstances are serious, the relevant responsible person and the unit shall not accept the application for large-scale medical equipment configuration license within 5 years. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income obtained from the unit during the illegal act, and a fine of 30% to 3 times the income obtained shall be imposed in accordance with the law.

Article 83: If false information is provided or other deceptive means are adopted when applying for the administrative license of medical devices, 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 income and medical devices used in illegal production and operation, 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 10000 yuan, a fine of not less than 50000 yuan but not more than 150000 yuan shall be imposed; If the value of the goods exceeds 10000 yuan, a fine of 15 to 30 times the value of the goods shall also be imposed; If the circumstances are serious, it shall be ordered to suspend production and business. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income obtained from the unit during the illegal act, and a fine of 30% to 3 times the income obtained shall be imposed. They shall be prohibited from engaging in medical device production and business activities for life.

Those who forge, alter, buy, sell, rent, or lend relevant medical device licenses shall be confiscated or revoked by the original issuing department, and their illegal gains shall be confiscated; If the illegal gains are less than 10000 yuan, a fine of not less than 50000 yuan but not more than 100000 yuan shall be imposed; If the illegal gains exceed 10000 yuan, a fine of 10 to 20 times the illegal gains shall 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: In any of the following circumstances, the department responsible for drug supervision and management shall announce the unit and product name to the society and order it to make corrections within a specified time limit; Those who fail to make corrections within the prescribed time limit shall have their illegal gains and medical devices illegally produced and operated confiscated; If the value of medical devices produced and operated illegally is less than 10000 yuan, a fine of not less than 10000 yuan but not more than 50000 yuan shall be imposed; If the value of the goods exceeds 10000 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 be confiscated of the income obtained from the unit during the illegal act, and a fine of 30% to 2 times the income shall be imposed. They shall be prohibited from engaging in medical device production and operation activities for 5 years:

（1） Production and operation of Class I medical devices without registration;

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

（3） The operation of Class II medical devices should be registered but has not been registered;

（4） The materials that have been filed do not meet the requirements.

Article 85: If false information is provided during the registration process, the department responsible for drug supervision and management shall publicly announce the registration unit and product name to the society, confiscate the illegal income and medical devices illegally produced and operated; If the value of medical devices produced and operated illegally is less than 10000 yuan, a fine of not less than 20000 yuan but not more than 50000 yuan shall be imposed; If the value of the goods exceeds 10000 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, it shall be ordered to suspend production and business. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income obtained from the unit during the illegal act, and a fine of 30% to 3 times the income obtained shall be imposed. They shall be prohibited 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 management shall order correction and confiscate the medical devices used in illegal production and operation; If the value of medical devices used in illegal production and operation is less than 10000 yuan, a fine of not less than 20000 yuan but not more than 50000 yuan shall be imposed; If the value of the goods exceeds 10000 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, it shall be ordered to suspend production and business, until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device operation license. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income earned from the unit during the illegal act, and a fine of 30% to 3 times the income earned shall be imposed, Prohibit them from engaging in medical device production and operation activities within 10 years:

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

（2） Failure to organize production in accordance with the registered or registered product technical requirements, or failure to establish a quality management system and maintain effective operation in accordance with the provisions of this regulation, which affects the safety and effectiveness of the product;

（3） Operating or using medical devices that do not have qualified certificates, have expired, become invalid, or have been eliminated, or using medical devices that have not been legally registered;

（4） Refusing to recall after being ordered by the department responsible for drug supervision and management, or refusing to stop the production, import, or operation of medical devices after being ordered to stop or suspend production, import, or operation by the department responsible for drug supervision and management;

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

（6） Import medical devices that have expired, become ineffective, or become obsolete.

Article 87: If a medical device operating enterprise or user unit fulfills the obligations of purchase inspection as stipulated in this Regulation and has sufficient evidence to prove that they are not aware that the medical device they operate or use is a medical device in the circumstances specified in Article 81, Paragraph 1, Paragraph 1, Article 84, Paragraph 1, Article 86, Paragraph 1, and Paragraph 3 of this Regulation, and can truthfully explain the source of their purchase, their business operations shall be confiscated Medical devices used that do not meet legal requirements can be exempted from administrative penalties.

Article 88: In any of the following circumstances, the department responsible for drug supervision and management shall order correction and impose a fine of not less than 10000 yuan but not more than 50000 yuan; Those who refuse to make corrections shall be fined not less than 50000 yuan but not more than 100000 yuan; If the circumstances are serious, it 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. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income earned from the unit during the period of illegal behavior, and a fine of 30% to 2 times the income earned shall be imposed. They shall be prohibited from engaging in medical device production and business activities 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 in accordance with the provisions of this regulation;

（2） Medical devices whose production or business instructions or labels do not comply with the provisions of this Regulation;

（3） Failure to transport and store medical devices in accordance with the instructions and labeling requirements for medical devices;

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

Article 89: In any of the following circumstances, the department responsible for drug supervision and management and the competent health department shall, in accordance with their respective responsibilities, order correction and issue a warning; Those who refuse to make corrections shall be fined not less than 10000 yuan but not more than 100000 yuan; If the circumstances are serious, it shall be ordered to suspend production and business, until the original issuing department revokes the medical device registration certificate, medical device production license, and medical device operation license. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be fined not less than 10000 yuan but not more than 30000 yuan:

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

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

（3） Medical device operating enterprises and user units have not established and implemented a medical device purchase inspection record system in accordance with the provisions of this Regulation;

（4） The operating enterprises engaged in the wholesale business of Class II and Class III medical devices, as well as the retail business of Class III medical devices, have not established and implemented a sales record system in accordance with the provisions of these Regulations;

（5） The medical device registrant, registrant, production and operation enterprise, or user fails to carry out adverse event monitoring of medical devices in accordance with the provisions of this Regulation, fails to report adverse events as required, or fails to cooperate with adverse event investigations conducted by medical device adverse event monitoring technical institutions, departments responsible for drug supervision and management, and health regulatory authorities;

（6） The medical device registrant and registrant did not develop a post market research and risk control plan in accordance with regulations and ensure effective implementation;

（7） The registrant and registrant of medical devices have not established and implemented a product traceability system in accordance with regulations;

（8） The medical device registrant, registrant, or operating enterprise engaged in online sales of medical devices did not inform the department responsible for drug supervision and management in accordance with regulations;

（9） For medical devices that require regular inspection, inspection, calibration, maintenance, and upkeep, the user unit of the medical device did not conduct inspection, inspection, calibration, maintenance, and upkeep in accordance with the requirements of the product manual, and timely analyzed and evaluated to ensure that the medical device is in good condition;

（10） The medical device user unit did not properly store the original information of the purchased Class III medical device.

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 correction and issue a warning; Those who refuse to make corrections shall be fined not less than 50000 yuan but not more than 100000 yuan; If the circumstances are serious, a fine of not less than 100000 yuan but not more than 300000 yuan shall be imposed, and the relevant medical device use activities shall be ordered to be suspended until the original issuing department revokes the practicing license. The relevant responsible personnel shall be ordered to suspend their practicing activities for not less than 6 months but not more than 1 year in accordance with the law, until the original issuing department revokes the practicing certificate of the relevant personnel. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be punished, Confiscate the income obtained from the unit during the period of illegal behavior, and impose a fine of 30% to 3 times the income obtained, and impose penalties in accordance with the law:

（1） The medical device user did not handle the reused medical devices in accordance with the disinfection and management regulations;

（2） The medical device user repeatedly uses disposable medical devices, or fails to destroy the used disposable medical devices in accordance with regulations;

（3） The medical device user unit did not record the information of large medical devices and implanted and interventional medical devices in relevant records such as medical records in accordance with regulations;

（4） If the medical device user discovers that the medical device in use has safety hazards and fails to immediately stop using or notify maintenance, or continues to use medical devices that cannot meet the safety standards after maintenance;

（5） The use of large medical equipment by medical device users in violation of regulations cannot guarantee medical quality and safety.

Article 91: If a medical device is imported in violation of relevant laws and administrative regulations on import and export commodity inspection, it shall be dealt with by the entry-exit inspection and quarantine institution in accordance with the law.

Article 92: Operators of e-commerce platforms providing services for online medical device transactions who violate the provisions of these Regulations and fail to fulfill their management obligations such as real name registration, examination of licenses, registrations, and records for online medical device operators, stopping and reporting illegal activities, and stopping the provision of online transaction platform services, The department responsible for drug supervision and management shall impose penalties in accordance with the provisions of the Electronic Commerce Law of the People's Republic of China.

Article 93: If a medical device clinical trial institution fails to register and conduct clinical trials, the department responsible for drug supervision and management shall order it to stop the clinical trial and make corrections; If the patient refuses to make corrections, the clinical trial data shall not be used for product registration or filing, and a fine of not less than 50000 yuan but not more than 100000 yuan shall be imposed, and it shall be announced to the society; If serious consequences are caused, the relevant professional medical device clinical trials shall be prohibited within 5 years, and a fine of not less than 100000 yuan but not more than 300000 yuan shall be imposed. The health regulatory department shall confiscate the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit during the illegal act, and impose a fine of not less than 30% but not more than three times the income obtained, and impose sanctions in accordance with the law.

If a clinical trial applicant conducts a clinical trial without filing, the department responsible for drug supervision and management shall order the suspension of the clinical trial, impose a fine of not less than 50000 yuan but not more than 100000 yuan on the clinical trial applicant, and make a public announcement; If serious consequences are caused, a fine of not less than 100000 yuan but not more than 300000 yuan shall be imposed. The clinical trial data shall not be used for product registration or filing, and medical device registration applications submitted by relevant responsible persons and units shall not be accepted within 5 years.

If a clinical trial applicant conducts a Class III medical device clinical trial without approval that poses a high risk to the human body, the department responsible for drug supervision and management shall order the immediate cessation of the clinical trial, impose a fine of not less than 100000 yuan but not more than 300000 yuan on the clinical trial applicant, and make a public announcement; If serious consequences are caused, a fine of not less than 300000 yuan but not more than 1 million yuan shall be imposed. The clinical trial data shall not be used for product registration. Medical device clinical trials and registration applications submitted by relevant responsible persons and units shall not be accepted within 10 years. The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income earned from the unit during the illegal act, and a fine of 30% to 3 times the income earned shall be imposed.

Article 94: If a medical device clinical trial institution fails to comply with clinical trial quality management standards when conducting medical device clinical trials, the department responsible for drug supervision and management shall order it to make corrections or immediately stop the clinical trial, and impose a fine of not less than 50000 yuan but not more than 100000 yuan; If serious consequences are caused, clinical trials of relevant professional medical devices shall be prohibited within 5 years. The health regulatory department shall confiscate the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit during the period of the illegal act, and impose a fine of 30% to 3 times the income obtained, and impose sanctions in accordance with the law.

Article 95: If a medical device clinical trial institution issues a false report, the department responsible for drug supervision and management shall impose a fine of not less than 100000 yuan but not more than 300000 yuan; If there are illegal gains, the illegal gains shall be confiscated; Prohibit them from conducting clinical trials of related professional medical devices within 10 years; The health regulatory department shall confiscate the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit during the period of the illegal act, and impose a fine of 30% to 3 times the income obtained, and impose sanctions in accordance with the law.

Article 96: If a medical device inspection institution issues a false inspection report, the competent department granting the qualification shall revoke the inspection qualification. Within 10 years, it shall not accept the qualification recognition application submitted by the relevant responsible person or unit, and shall also be fined not less than 100000 yuan but not more than 300000 yuan; If there are illegal gains, the illegal gains shall be confiscated; The legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be confiscated of the income obtained from the unit during the illegal act, and a fine of 30% to 3 times the income obtained shall be imposed in accordance with the law; Those who are dismissed shall be prohibited from engaging in medical device inspection work for 10 years.

Article 97: Those who violate 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: If a domestic enterprise legal person designated by an overseas medical device registrant or registrant fails to fulfill its relevant obligations in accordance with the provisions of these Regulations, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order it to make corrections, issue a warning, and impose a fine of not less than 50000 yuan but not more than 100000 yuan; If the circumstances are serious, a fine of not less than 100000 yuan but not more than 500000 yuan shall be imposed, and the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel shall be prohibited from engaging in medical device production and operation activities within 5 years.

If an overseas medical device registrant or registrant refuses to comply with the administrative penalty decision made in accordance with these regulations, the import of their medical devices shall be prohibited for 10 years.

Article 99: If medical device research and development, production, and operation units, as well as inspection institutions, violate the provisions of this Regulation by using personnel prohibited from engaging in medical device production and operation activities or inspection work, the department responsible for drug supervision and management shall order them to make corrections and give them a warning; Those who refuse to make corrections shall be ordered to suspend production and business until their licenses are revoked.

Article 100: If a medical device technical evaluation institution or a medical device adverse event monitoring technical institution fails to fulfill their duties in accordance with the provisions of these Regulations, resulting in significant errors in the evaluation and monitoring work, the department responsible for drug supervision and management shall order correction, circulate a notice of criticism, and give a warning; If serious consequences are caused, the legal representative, main responsible person, directly responsible supervisor, and other responsible personnel of the illegal unit shall be punished in accordance with the law.

Article 101: Personnel of the department responsible for drug supervision and management or other relevant departments who violate the provisions of these Regulations, abuse their power, neglect their duties, or engage in favoritism and fraud shall be punished in accordance with the law.

Article 102: If a violation of the provisions of these Regulations constitutes a crime, criminal responsibility shall be pursued in accordance with the law; If it causes personal, property or other damage, it shall be liable for compensation in accordance with the law.

Chapter 8 Supplementary Provisions

Article 103 The meanings 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 required computer software; Its effectiveness is mainly obtained through physical and other means, not through pharmacology, immunology, or metabolism, or although these methods are involved, they only have auxiliary effects; Its purpose is to:

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

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

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

（4） Support or maintenance of life;

（5） Pregnancy control;

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

Medical device registrant and registrant refer to enterprises or research institutions that have obtained a medical device registration certificate or processed medical device registration.

Medical device users 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 stations, single plasma collection stations, rehabilitation assistance device adaptation institutions, etc.

Large medical equipment refers to large-scale medical devices that have complex technology, large capital investment, high operating costs, significant impact on medical expenses, and are included in catalog management.

Article 104: Medical device product registration may charge fees. The specific charging items and standards shall be formulated by the finance and pricing departments of the State Council in accordance with relevant national regulations.

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

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

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

Article 107: These regulations shall come into effect from June 1, 2021.