Order of the State Council of the People's Republic of China
No. 680
The "Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices" is hereby promulgated, which shall come into force on the date of promulgation.
Prime Minister Li Keqiang
May 4, 2017
Decision of the State Council on Amending the "Regulations on the Supervision and Administration of Medical Devices"
The State Council decided to make the following amendments to the "Regulations on the Supervision and Administration of Medical Devices":
1. Amend Article 18 to read: "Clinical trials of medical devices shall be carried out in clinical trial institutions with corresponding conditions in accordance with the requirements of the quality management standards for medical device clinical trials, and shall be reported to the province, autonomous region, The food and drug supervision and administration department of the people's government of the municipality directly under the Central Government for the record. The food and drug supervision and administration department that accepts the clinical trial registration shall notify the food and drug supervision and administration department and the health and family planning department at the same level where the clinical trial institution is located.
"Medical device clinical trial institutions shall implement record management. The conditions that medical device clinical trial institutions should have, the record management measures and clinical trial quality management standards shall be formulated and announced by the Food and Drug Administration of the State Council in conjunction with the health and family planning authority of the State Council."
2. Combining the first and second paragraphs of Article 34 as the first paragraph: "Medical device users shall have storage places 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 and technical operating specifications."
One paragraph is added as the second paragraph: "Medical device users should configure large-scale medical equipment in accordance with the large-scale medical equipment configuration plan formulated by the health and family planning department of the State Council, meet their functional positioning and clinical service needs, and have corresponding technical conditions, Supporting facilities and professional and technical personnel with corresponding qualifications and abilities have been approved by the health and family planning department of the people's government at or above the provincial level to obtain a large-scale medical equipment configuration license."
One paragraph is added as the third paragraph: "The measures for the configuration and management of large-scale medical equipment are formulated by the health and family planning department of the State Council in conjunction with the relevant departments of the State Council. The large-scale medical equipment catalogue is proposed by the health and family planning department of the State Council in consultation with the relevant departments of the State Council and implemented after being approved by the State Council. "
3. Combine the first and second paragraphs of Article 56 as the first paragraph: "The food and drug regulatory authority shall strengthen the random inspection and inspection of medical devices produced, operated, and used by medical device manufacturers and users. The inspection fee and any other fees shall not be charged for random inspections, and the required expenses shall be included in the budget of the government at the same level. The food and drug supervision and administration department of the people's government at or above the provincial level shall issue a medical device quality announcement in a timely manner based on the results of the random inspection.
One paragraph is added as the second paragraph: "The health and family planning authority shall supervise and evaluate the use of large-scale medical equipment; if illegal use and excessive inspections and over-treatments related to large-scale medical equipment are found, they shall be corrected immediately. Deal with it according to law."
4. One paragraph is added to Article 63 as the third paragraph: “Where large-scale medical equipment is deployed and used without permission, the health and family planning department of the people’s government at or above the county level shall order it to stop using it, give a warning, and confiscate the illegal income; If the income is less than 10,000 yuan, a fine of 10,000 yuan or more and less than 50,000 yuan shall be imposed; if the illegal income is more than 10,000 yuan, a fine of 5 times to 10 times the illegal income shall be imposed; if the circumstances are serious, the responsible person will not be accepted within 5 years And the unit’s application for a large-scale medical equipment configuration permit."
5. Amend the first paragraph of Article 64 to read: "Provide false information or adopt other deceptive means to obtain medical device registration certificate, medical device production license, medical device business license, large-scale medical equipment configuration license, and advertisement approval For documents and other licenses, the original license-issuing department shall revoke the licenses already obtained, and impose a fine of 50,000 yuan up to 100,000 yuan, and the relevant responsible persons and units will not accept medical device license applications for 5 years."
6. A paragraph is added to Article 66 as the second paragraph: "Medical device operating enterprises and user units have fulfilled the obligations of purchase inspection and other requirements stipulated in this Regulation, and have sufficient evidence to prove that they do not know that the medical devices they operate and use are Medical devices under the conditions specified in the first and third items of the preceding paragraph can be exempted from punishment if they can truthfully state the source of their purchases, but medical devices that do not meet the statutory requirements shall be confiscated according to law."
7. Article 68 adds one item as the ninth item: "(9) Medical device users use large-scale medical equipment in violation of regulations and cannot guarantee medical quality and safety", and change the original ninth item to the tenth item.
8. Amend Article 69 to read: "Whoever conducts clinical trials of medical devices in violation of these regulations shall be ordered by the food and drug regulatory authority of the people's government at or above the county level to make corrections or stop clinical trials immediately, and may impose a fine of less than 50,000 yuan; If serious consequences are caused, the directly responsible person in charge and other directly responsible personnel shall be degraded, dismissed or expelled according to law; the institution shall not conduct clinical trials of relevant professional medical devices within 5 years.
"If a medical device clinical trial institution issues a false report, the food and drug regulatory department of the people’s government at or above the county level shall impose a fine of 50,000 yuan up to 100,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; the directly responsible persons in charge and other Persons directly responsible shall be dismissed or expelled in accordance with the law; the institution shall not conduct clinical trials of relevant professional medical devices within 10 years."
9. Amend Article 73 to read: "Food and drug regulatory authorities, health and family planning authorities and their staff shall strictly comply with the types and ranges of penalties stipulated in these Regulations, and exercise the power of administrative penalties according to the nature and specific circumstances of the violations. The specific measures shall be formulated by the Food and Drug Administration Department and the Health and Family Planning Department of the State Council in accordance with their respective duties."
10. Article 76 adds a provision: "Large-scale medical equipment refers to large-scale medical equipment that has complex technology, large capital investment, high operating costs, large impact on medical expenses, and is included in catalog management."
This decision shall be implemented from the date of announcement.
The Regulations on the Supervision and Administration of Medical Devices shall be revised and re-announced according to this decision.
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, as amended and adopted at the 39th executive meeting of the State Council on February 12, 2014. According to the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017 》Revision)
Chapter One: General Rules
Article 1 "In order to ensure the safety and effectiveness of medical devices, and to protect human health and life safety, these regulations are formulated.
Article 2 Those engaged in the development, production, operation, use and supervision of medical devices within the territory of the People's Republic of China shall comply with these regulations.
Article 3 The Food and Drug Administration of the State Council is responsible for the supervision and administration 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.
The food and drug supervision and administration department of the local people's government at or above the county level is responsible for the supervision and administration of medical devices in its administrative area. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of medical devices within their respective responsibilities.
The Food and Drug Administration Department of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry planning and policies.
Article 4 The state implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, and the implementation of routine management can ensure their safety and effectiveness.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that have higher risks and require special measures to strictly control and manage to ensure their safety and effectiveness.
Evaluating the degree of risk of medical devices should consider factors such as the intended purpose, structural characteristics, and use methods of the medical device.
The Food and Drug Administration Department of the State Council is responsible for formulating the classification rules and classification catalogs of medical devices, and according to the production, operation and use of medical devices, timely analyze and evaluate the risk changes of medical devices, and adjust the classification catalogs. To formulate and adjust the classification catalog, the opinions of medical device manufacturers, users, and industry organizations should be fully listened to, and the practice of international medical device classification should be referred to. The classification catalog of medical devices shall be published to the public.
Article 5: The development of medical devices shall follow the principles of safety, effectiveness and economy. The state encourages the research and innovation of medical devices, gives play to the role of market mechanisms, promotes the promotion and application of new medical device technologies, and promotes the development of the medical device industry.
Article 6 Medical device products shall meet the mandatory national standards for medical devices; if there are no mandatory national standards, they shall meet the mandatory industry standards for medical devices.
The list of disposable medical devices shall be formulated, adjusted and published by the Food and Drug Administration of the State Council in conjunction with the health and family planning department of the State Council. Medical devices that can be reused to ensure safety and effectiveness are not included in the list of disposable medical devices. For medical devices whose design, production process, disinfection and sterilization technology, etc. are improved after repeated use can ensure safety and effectiveness, a catalog of disposable medical devices should be adjusted.
Article 7 Medical device industry organizations shall strengthen industry self-discipline, promote the establishment of a credit system, urge enterprises to carry out production and business activities in accordance with the law, and guide enterprises to be honest and trustworthy.
Chapter 2 Medical Device Product Registration and Filing
Article 8 The first category medical devices are subject to product registration management, and the second and third category medical devices are subject to product registration management.
Article 9 The first class medical device product filing and the application for the second and third class medical device product registration shall submit the following materials:
(1) Product risk analysis data;
(2) Product technical requirements;
(3) Product inspection report;
(4) Clinical evaluation data;
(5) Product manual and label samples;
(6) Quality management system documents related to product development and production;
(7) Other materials needed to prove that the product is safe and effective.
Medical device registration applicants and filing holders shall be responsible for the authenticity of the submitted materials.
Article 10: For the filing of Class I medical device products, the filing person shall submit the filing materials to the food and drug regulatory department of the municipal people's government at the local level. Among them, the product inspection report can be the self-inspection report of the filing person; the clinical evaluation data does not include the clinical trial report, it can be the data that proves the safety and effectiveness of the medical device through literature and data obtained from the clinical use of similar products.
For overseas manufacturing enterprises that export Class I medical devices to my country, their representative offices in my country or designated corporate legal persons in my country shall be their agents, and submit the filing materials and the country where the filing person is located to the Food and Drug Administration of the State Council ( Region) the certification document that the competent authority approves the medical device for sale.
If there are changes in the matters stated in the filing materials, the filing shall be changed to the original filing department.
Article 11: To apply for the second category of medical device product registration, the registration applicant shall submit the registration application materials to the food and drug regulatory department of the local province, autonomous region, or municipality. To apply for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the Food and Drug Administration of the State Council.
Overseas manufacturing enterprises that export Class II and Class III medical devices to my country shall have their representative offices established in my country or designate corporate legal persons in my country as their agents, and submit registration application materials to the Food and Drug Administration of the State Council And the certification documents of the competent authority of the country (region) where the registration applicant is located to allow the medical device to be marketed.
The product inspection reports in the second and third categories of medical device product registration application materials shall be the inspection reports issued by the medical device inspection agency; the clinical evaluation materials shall include clinical trial reports, but they shall be exempted in accordance with Article 17 of these regulations. Except for medical devices undergoing clinical trials.
Article 12: The food and drug regulatory authority that accepts the registration application shall forward the registration application materials to the technical review agency within 3 working days from the date of acceptance. The technical review agency shall submit the review opinions to the food and drug regulatory authority after completing the technical review.
Article 13 The food and drug regulatory authority that accepts the registration application shall make a decision within 20 working days from the date of receiving the review comments. For those that meet the requirements for safety and effectiveness, the registration is approved and a medical device registration certificate is issued; for those that do not meet the requirements, the registration is not granted and the reasons are stated in writing.
When the Food and Drug Administration of the State Council considers that it is necessary to check the quality management system when organizing the technical review of imported medical devices, it shall organize the quality management system inspection technical institution to carry out the quality management system verification.
Article 14 For registered medical device products of Class II and Class III, the design, raw materials, production process, scope of application, method of use, etc. have undergone substantial changes, which may affect the safety and effectiveness of the medical device, the registrant It should apply to the original registration department to go through the procedures for changing the registration; if there is an insubstantial change that does not affect the safety and effectiveness of the medical device, the change should be filed with the original registration department.
Article 15 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 the registration shall be submitted to the original registration department 6 months before the expiration of the validity period.
Except for the circumstances specified in paragraph 3 of this article, the Food and Drug Administration that receives an application for renewal of registration shall make a decision to approve the renewal before the expiry of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed that the renewal is approved.
In any of the following circumstances, registration shall not be renewed:
(1) The registrant fails to file 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) For medical devices that are used to treat rare diseases and urgently needed to respond to public health emergencies, failing to complete the matters specified in the medical device registration certificate within the prescribed time limit.
Article 16 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 regulations on the third category of medical device product registration, or they may determine the product category according to the classification rules and apply to the State Council Food After the drug regulatory department applies for category confirmation, it applies for registration or product filing in accordance with these regulations.
Directly applying for the registration of Class III medical device products, the Food and Drug Administration of the State Council shall determine the category according to the degree of risk, and timely include the registered medical devices into the classification list. If the application category is confirmed, the Food and Drug Administration Department of the State Council shall determine the category of the medical device and notify the applicant within 20 working days from the date of acceptance of the application.
Article 17 The filing of Class I medical device products does not require clinical trials. To apply for the registration of Class II and Class III medical device products, clinical trials shall be conducted; however, clinical trials may be exempted in any of the following circumstances:
(1) The working mechanism is clear, the design is finalized, the production process is mature, the medical devices of the same variety that have been marketed have been used in clinical applications for many years, and there is no record of serious adverse events, and the conventional use is not changed;
(2) It can be proved that the medical device is safe and effective through non-clinical evaluation;
(3) Through analysis and evaluation of data obtained from clinical trials or clinical use of the same type of medical device, it can be proved that the medical device is safe and effective.
The list of medical devices exempt from clinical trials shall be formulated, adjusted and published by the Food and Drug Administration of the State Council.
Article 18 The clinical trials of medical devices shall be carried out in clinical trial institutions with corresponding conditions in accordance with the requirements of the quality management standards for medical device clinical trials, and shall be submitted to the food and drug supervision and management of the people’s government of the province, autonomous region, and municipality where the clinical trial is proposed. Department record. The food and drug supervision and administration department that accepts the clinical trial filing shall notify the food and drug supervision and administration department and the health and family planning department at the same level where the clinical trial institution is located.
Medical device clinical trial institutions implement record management. The conditions that medical device clinical trial institutions should have, the filing management measures and clinical trial quality management standards shall be formulated and announced by the Food and Drug Administration of the State Council in conjunction with the health and family planning department of the State Council.
Article 19 The clinical trials of Class III medical devices that pose a high risk to humans shall be approved by the Food and Drug Administration of the State Council. The catalogue of the third category of medical devices with higher risks to humans in clinical trials shall be formulated, adjusted and published by the Food and Drug Administration of the State Council.
The Food and Drug Administration of the State Council shall review and approve clinical trials, and shall comprehensively review the equipment, professionals and other conditions of the institution that intends to undertake clinical trials of medical devices, the degree of risk of the medical device, clinical trial implementation plan, clinical benefit and risk comparison analysis report, etc. analysis. If a clinical trial is approved, the applicant of the clinical trial and the food and drug regulatory department and the health and family planning department of the people's government of the province, autonomous region, or municipality where the clinical trial institution is located shall be notified.
Chapter Three Medical Device Production
Article 20: Engaging in medical device production activities shall meet the following conditions:
(1) Have production sites, environmental conditions, production equipment, and professional and technical personnel suitable for the medical devices produced;
(2) Have institutions or full-time inspectors and inspection equipment that conduct quality inspections on the medical devices produced;
(3) Have a management system to ensure the quality of medical devices;
(4) Having after-sales service capabilities that are compatible with the medical devices produced;
(5) Requirements stipulated in product development and production process documents.
Article 21: Those engaged in the production of Class I medical devices shall be filed with the food and drug regulatory department of the people's government at the districted city level by the manufacturer and shall submit the certification materials that they meet the conditions specified in Article 20 of these Regulations.
Article 22 For those engaged in the production of Class II and Class III medical devices, the manufacturer shall apply to the food and drug regulatory department of the local province, autonomous region, or municipality directly under the Central Government for a production license and submit that it meets the conditions specified in Article 20 of these regulations. The certification materials and the registration certificate of the medical device produced.
The food and drug administration department that accepts the production license application shall review the application materials within 30 working days from the date of acceptance, and conduct verification in accordance with the requirements of the medical device production quality management regulations formulated by the food and drug administration department of the State Council. For those that meet the specified conditions, the license is granted and a medical device production license is issued; for those that do not meet the specified conditions, the license is not granted and the reasons are stated 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 handled in accordance with the legal provisions of the relevant administrative license.
Article 23 Medical device production quality management standards shall clearly stipulate the design and development of medical devices, production equipment conditions, raw material procurement, production process control, enterprise organization and staffing, and other matters that affect the safety and effectiveness of medical devices.
Article 24 The medical device manufacturer shall establish and improve the quality management system compatible with the medical devices produced and ensure its effective operation in accordance with the requirements of the medical device production quality management norms; organize in strict accordance with the registered or filed product technical requirements Production, to ensure that the medical devices that leave the factory meet the mandatory standards and the technical requirements of the registered or filed products.
Medical device manufacturers should regularly conduct self-inspection on the operation of the quality management system and submit a self-inspection report to the food and drug regulatory department of the local province, autonomous region, or municipality.
Article 25 If the production conditions of a medical device manufacturer change and no longer meet the requirements of the medical device quality management system, the medical device manufacturer should immediately take corrective measures; if it may affect the safety and effectiveness of the medical device, it should immediately stop production activities , And report to the food and drug administration department of the people's government at the county level.
Article 26 Medical devices shall use generic names. The generic name shall comply with the medical device naming rules formulated by the Food and Drug Administration of the State Council.
Article 27 Medical devices shall have instructions and labels. The contents of the instructions and labels shall be consistent with the relevant contents registered or filed.
The instructions and labels of medical devices shall indicate the following items:
(1) Common name, model, specification;
(2) The name and domicile, production address and contact information of the production enterprise;
(3) The serial number of product technical requirements;
(4) Date of production and period of use or expiration date;
(5) Product performance, main structure and scope of application;
(6) Contraindications, precautions and other content that needs warning or reminder;
(7) Installation and use instructions or pictures;
(8) Maintenance and maintenance methods, special storage conditions and methods;
(9) Other content that should be indicated in the product technical requirements.
The second and third categories of medical devices shall also indicate the medical device registration certificate number and the name, address and contact information of the medical device registrant.
Medical devices used by consumers themselves should also have special instructions for safe use.
Article 28 The entrusted production of medical devices shall be responsible for the quality of the entrusted medical devices. The entrusted party shall be a medical device manufacturer that meets the requirements of these regulations and has corresponding production conditions. The entrusting party shall strengthen the management of the entrusted party’s production activities and ensure that it conducts production in accordance with legal requirements.
High-risk implantable medical devices shall not be commissioned for production. The specific catalogue shall be formulated, adjusted and announced by the Food and Drug Administration of the State Council.
Chapter Four Medical Device Operation and Use
Article 29 To engage in medical device business activities, there shall be business premises and storage conditions commensurate with the business scale and business scope, as well as a quality management system and quality management agency or personnel commensurate with the medical devices being operated.
Article 30: For those engaged in the business of Class II medical devices, the business enterprise shall file with the food and drug regulatory department of the municipal people's government at the districted level and submit the certification materials that it meets the requirements of Article 29 of these regulations.
Article 31 For the operation of the third-class medical device, the operating enterprise shall apply to the food and drug regulatory department of the municipal people’s government with districts in the place where it is located and submit the certification materials that it meets the requirements of Article 29 of these regulations. .
The food and drug administration department that accepts the business license application shall conduct an inspection within 30 working days from the date of acceptance, and organize an inspection if necessary. For those that meet the prescribed conditions, the license is granted and a medical device business license is issued; for those that do not meet the prescribed conditions, the license is not granted and the reasons are stated 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 handled in accordance with the legal provisions of the relevant administrative license.
Article 32 Medical device business enterprises and user units purchasing medical devices shall check the supplier’s qualifications and medical device qualification documents, and establish a purchase inspection record system. Business enterprises engaged in the wholesale business of Type II and Type III medical devices and the retail business of Type III medical devices shall also establish a sales record system.
Record items include:
(1) The name, model, specification and quantity of the medical device;
(2) The production batch number, expiry date, and sales date of the medical device;
(3) The name of the manufacturer;
(4) The name, address and contact information of the supplier or purchaser;
(5) Numbers of relevant license certificates, etc.
The purchase inspection records and sales records shall be true and kept in accordance with the time limit prescribed by the Food and Drug Administration Department of the State Council. The state encourages the use of advanced technology to record.
Article 33 The transportation and storage of medical devices shall comply with the requirements of the 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 the medical devices.
Article 34 The medical device user unit shall have a storage place and conditions suitable for the variety and quantity of the medical device in use. The medical device user unit shall strengthen the technical training of the staff, and use the medical device in accordance with the requirements of the product manual and technical operation specifications.
The deployment of large-scale medical equipment by the medical device user unit shall comply with the large-scale medical equipment configuration plan formulated by the health and family planning department of the State Council, meet its functional positioning and clinical service needs, and have corresponding technical conditions, supporting facilities, and professional qualifications and capabilities. Technical personnel, and approved by the health and family planning department of the people's government at or above the provincial level, have obtained a large-scale medical equipment configuration permit.
The measures for the management of large-scale medical equipment configuration are formulated by the health and family planning department of the State Council in conjunction with relevant departments of the State Council. The large-scale medical equipment catalog is proposed by the State Council's health and family planning department in consultation with the relevant departments of the State Council, and implemented after being approved by the State Council.
Article 35 Medical device users shall deal with reusable medical devices in accordance with the disinfection and management regulations formulated by the health and family planning department of the State Council.
Disposable medical devices shall not be reused, and those used shall be destroyed and recorded in accordance with relevant national regulations.
Article 36 For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, medical device users shall perform inspection, inspection, calibration, maintenance, and maintenance in accordance with the requirements of the product manual, and record them, and conduct timely analysis and evaluation. , To ensure that medical devices are in good condition and guarantee the quality of use; for large medical devices with a long service life, use files should be established one by one to record their use, maintenance, transfer, and actual use time. The record retention period shall not be less than 5 years after the expiration of the prescribed use period of the medical device.
Article 37 Medical device users shall properly keep the original materials of the third-class medical devices purchased and ensure that the information is traceable.
When large-scale medical devices and implantable and interventional medical devices are used, information such as the name of the medical device, key technical parameters, and necessary information closely related to the quality and safety of use shall be recorded in relevant records such as medical records.
Article 38 If the medical device used is found to have potential safety hazards, the medical device user shall immediately stop using it and notify the manufacturer or other organization responsible for product quality to conduct inspections; medical devices that still cannot meet the safety standards for use after inspections, No further use.
Article 39 The food and drug supervision and administration department and the health and family planning department shall supervise and manage the quality of medical devices and the behavior of medical devices in use according to their respective duties.
Article 40 Medical device operating companies and user units shall not operate or use medical devices that have not been registered according to law, have no conformity certification documents, and have expired, expired, or eliminated.
Article 41 When medical device users transfer medical devices in use between medical device users, the transferor shall ensure that the transferred medical devices are safe and effective, and shall not transfer expired, invalid, obsolete or unqualified medical devices.
Article 42 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 the place of origin of the medical device and the name, address and contact information of the agent shall be stated in the instructions. No Chinese instructions, Chinese labels or instructions or labels that do not comply with the provisions of this Article shall not be imported.
Article 43 The entry-exit inspection and quarantine agency shall conduct inspections on imported medical devices according to law; those that fail the inspection shall not be imported.
The Food and Drug Administration Department of 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 where the import port is located shall promptly report the customs clearance of imported medical devices to the food and drug administration department of the municipal people's government at the districted level.
Article 44: Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).
Article 45 Medical device advertisements shall be true and legal, and shall not contain false, exaggerated or misleading content.
Medical device advertisements shall be reviewed and approved by the food and drug regulatory department of the province, autonomous region, or municipality where the medical device manufacturer or imported medical device agent is located, and the medical device advertisement approval document shall be obtained. Advertisement publishers publishing medical device advertisements shall check the approval documents of the advertisements and their authenticity in advance; they shall not publish medical device advertisements that have not obtained the approval documents, the authenticity of the approval documents have not been verified, or the contents of the advertisements are inconsistent with the approval documents. The food and drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall publish and timely update the approved medical device advertisement catalogue and approved advertisement content.
The food and drug supervision and administration department of the people's government at or above the provincial level shall order the suspension of the production, sale, import and use of medical devices. During the suspension period, advertisements involving such medical devices shall not be published.
The measures for reviewing medical device advertisements are formulated by the Food and Drug Administration of the State Council in conjunction with the Administration for Industry and Commerce of the State Council.
Chapter 5: Handling of Adverse Events and Recall of Medical Devices
Article 46: The state establishes a medical device adverse event monitoring system to collect, analyze, evaluate, and control medical device adverse events in a timely manner.
Article 47 Medical device manufacturers and users shall monitor the medical devices produced, operated or used by adverse events; discover medical device adverse events or suspicious adverse events, they shall report to the State Council’s Food and Drug Administration Medical device adverse event monitoring technical agency report.
Any unit or individual who discovers medical device adverse events or suspicious adverse events shall have the right to report to the food and drug regulatory authority or medical device adverse event monitoring technical agency.
Article 48: The Food and Drug Administration Department of the State Council shall strengthen the construction of a medical device adverse event monitoring information network.
Medical device adverse event monitoring technical institutions shall strengthen the monitoring of medical device adverse event information and actively collect adverse event information; if an adverse event is discovered or an adverse event report is received, it shall promptly verify, investigate, analyze, evaluate the adverse event, and report to The food and drug supervision and administration department and the health and family planning department put forward suggestions for handling.
Medical device adverse event monitoring technical institutions shall publish contact information to facilitate medical device manufacturers and users to report medical device adverse events.
Article 49 The food and drug regulatory authority shall, based on the assessment results of the adverse events of medical devices, take timely control measures such as issuing warning information and ordering the suspension of production, sales, import and use.
The food and drug supervision and administration department of the people’s government at or above the provincial level shall, in conjunction with the health and family planning department at the same level and relevant departments, organize timely investigation and treatment of medical device adverse events that cause sudden, mass injuries or deaths, and organize the investigation of similar medical devices Strengthen monitoring.
Article 50 Medical device production and operation enterprises and user units shall cooperate with the medical device adverse event monitoring technical institution and the food and drug supervision and management department in the medical device adverse event investigation.
Article 51: In any of the following situations, the food and drug regulatory department of the people's government at or above the provincial level shall organize re-evaluation of registered medical devices:
(1) According to the development of scientific research, there is a change in understanding of the safety and effectiveness of medical devices;
(2) The monitoring and evaluation results of the adverse event of the medical device indicate that the medical device may have defects;
(3) Other situations that require re-evaluation as required by the Food and Drug Administration of the State Council.
If the result of the re-evaluation shows that the registered medical device cannot be guaranteed to be safe and effective, the original issuing authority shall cancel the medical device registration certificate and announce it to the public. Medical devices whose registration certificates for medical devices have been cancelled shall not be produced, imported, operated, or used.
Article 52 If a medical device manufacturer discovers that the medical device it produces does not meet the mandatory standards, the technical requirements of the registered or filed product, or other defects, it shall immediately stop production and notify the relevant production and operation enterprises, users and consumers Stop operation and use, recall medical devices that have been on the market, take measures such as remediation and destruction, record relevant conditions, release relevant information, and report the recall and handling of medical devices to the food and drug regulatory authorities and the health and family planning authorities.
If a medical device business enterprise discovers that the medical device it operates under the conditions specified in the preceding paragraph, it shall immediately stop its operation, notify the relevant production and operation enterprise, user unit, and consumer, and record the suspension of operation and notification. The medical device manufacturer believes that the medical device that needs to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.
If a medical device manufacturer fails to implement a recall or cease operations in accordance with the provisions of this Article, the Food and Drug Administration may order it to recall or cease operations.
Chapter VI Supervision and Inspection
Article 53: The food and drug regulatory authority shall strengthen the supervision and inspection of the registration, filing, production, operation and use of medical devices, and conduct key supervision and inspection on the following matters:
(1) Whether the medical device manufacturer organizes production in accordance with the registered or filed product technical requirements;
(2) Whether the quality management system of the medical device manufacturer maintains effective operation;
(3) Whether the production and operation conditions of the medical device production and operation enterprise continue to meet the legal requirements.
Article 54 The food and drug supervision and administration department shall have the following powers in supervision and inspection:
(1) Enter the site to conduct inspections and sample samples;
(2) Consult, copy, seal up, and detain relevant contracts, bills, account books and other relevant materials;
(3) Seal up and seize medical devices that do not meet statutory requirements, illegally used spare parts, raw materials, and tools and equipment used for illegally producing medical devices;
(4) Seal up places that violate the provisions of these regulations and engage in medical device production and business activities.
In conducting supervision and inspection, the food and drug supervision and administration department shall show law enforcement certificates and keep the business secrets of the inspected entity.
Relevant units and individuals shall cooperate in the supervision and inspection of food and drug supervision and administration departments, and shall not conceal relevant information.
Article 55: For medical devices that cause harm to the human body or have evidence that may endanger human health, the food and drug supervision and administration department may take emergency control measures to suspend production, import, operation and use.
Article 56 The food and drug supervision and administration department shall strengthen the random inspection and inspection of the medical devices produced, operated, and used by medical device manufacturers and users. Random inspections shall not charge inspection fees and any other expenses, and the required expenses shall be included in the budget of the government at this level. The food and drug supervision and administration department of the people's government at or above the provincial level shall promptly issue a medical device quality announcement based on the conclusions of random inspections.
The competent department of health and family planning shall supervise and evaluate the use of large-scale medical equipment; if it finds illegal use and excessive inspection and over-treatment related to large-scale medical equipment, it shall immediately correct it and deal with it according to law.
Article 57 The qualification accreditation of medical device inspection institutions shall be managed in a unified manner in accordance with relevant national regulations. Only the inspection agency recognized by the certification and accreditation supervision and management department of the State Council and the food and drug regulatory department of the State Council can carry out inspections on medical devices.
If the food and drug regulatory authority needs to inspect medical devices in law enforcement work, it shall entrust a qualified medical device inspection agency to conduct the inspection and pay the relevant expenses.
If the parties have objections to the inspection conclusions, they may select a qualified medical device inspection agency for re-inspection within 7 working days from the date of receipt of the inspection conclusions. The medical device inspection agency undertaking the re-inspection work shall make a re-inspection conclusion within the time specified by the Food and Drug Administration Department of the State Council. The re-inspection conclusion is the final inspection conclusion.
Article 58 For medical devices that may contain harmful substances or change the design, raw materials and production processes of medical devices without authorization and have potential safety hazards, medical devices cannot be inspected in accordance with the inspection items and inspection methods specified in the national standards and industry standards for medical devices. The inspection agency may supplement the inspection items and inspection methods for inspection; the inspection conclusions drawn from the supplementary inspection items and inspection methods, approved by the Food and Drug Administration of the State Council, can be used as the basis for the food and drug administration to determine the quality of medical devices.
Article 59 The food and drug regulatory authorities of the people’s governments at the districted city and county levels shall strengthen the supervision and inspection of medical device advertisements; if any medical device advertisements that have not been approved or tampered with the approved contents of the advertisements, they shall report to the local province. , The food and drug supervision and administration department of the people's government of autonomous region and municipality directly under the Central Government shall make an announcement to the public.
The administrative department for industry and commerce shall supervise and inspect medical device advertisements in accordance with relevant advertising management laws and administrative regulations, and investigate and deal with illegal acts. When the food and drug regulatory authority discovers illegal publishing of medical device advertisements, it shall put forward suggestions for handling and transfer it to the administrative department for industry and commerce at the same level in accordance with relevant procedures.
Article 60 The Food and Drug Administration Department of the State Council shall establish a unified medical device supervision and management information platform. The food and drug supervision and administration department shall, through the information platform, promptly publish the daily supervision and management information of medical device licensing, filing, random inspection, investigation and punishment of illegal acts, etc. However, the commercial secrets of the parties shall not be disclosed.
The food and drug supervision and administration department shall establish credit files for medical device registrants and recorders, production and operation enterprises, and users, and increase the frequency of supervision and inspection for those with bad credit records.
Article 61 Food and Drug Administration and other departments shall publish the contact information of the unit, and accept consultation, complaint, and report. Food and Drug Administration and other departments shall promptly respond to inquiries related to the supervision and management of medical devices; when they receive complaints and reports, they shall verify, handle and respond in a timely manner. The consultations, complaints, and reports, as well as their responses, verification, and handling, shall be recorded and kept.
If a report on the research, production, operation, and use of medical devices is true after investigation, the Food and Drug Administration and other departments shall reward the reporter.
Article 62 The Food and Drug Administration Department of the State Council shall publicly solicit opinions when formulating, adjusting, and revising the catalogs and regulations related to the supervision and management of medical devices; it shall take the form of hearings and demonstration meetings to listen to experts and medical devices Opinions from production and operation enterprises and users, consumers and related organizations.
Chapter VII Legal Liability
Article 63: In any of the following circumstances, the food and drug supervision and administration department of the people's government at or above the county level shall confiscate illegal income, medical devices used in illegal production and operation, and tools, equipment, raw materials and other items used in illegal production and operation; illegal production If the value of the medical device is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 100,000 yuan shall be imposed; if the value of the medical device is more than 10,000 yuan, a fine of 10 times to 20 times the value of the goods shall be imposed; the circumstances are serious , The medical device license applications submitted by relevant responsible persons and enterprises will not be accepted within 5 years:
(1) Production and operation of Class II and Class III medical devices without a medical device registration certificate;
(2) Engaging in the production of Class II and Class III medical devices without permission;
(3) Engaging in the business activities of Class III medical devices without permission.
In the case of the first item in the preceding paragraph and the circumstances are serious, the original license-issuing department shall revoke the medical device production license or medical device business license.
If large-scale medical equipment is configured and used without permission, the health and family planning department of the people's government at or above the county level shall order it to stop using, give a warning, and confiscate the illegal income; if the illegal income is less than 10,000 yuan, it shall be punished with a penalty of more than 10,000 yuan and less than 50,000 yuan Fines; if the illegal gains are more than 10,000 yuan, a fine of 5 times to 10 times the illegal gains shall be imposed; if the circumstances are serious, applications for large-scale medical equipment configuration licenses submitted by relevant responsible persons and units will not be accepted within 5 years.
Article 64 Where false information is provided or other deceptive methods are used to obtain medical device registration certificates, medical device production licenses, medical device business licenses, large-scale medical equipment configuration licenses, advertisement approval documents, etc., the original certificate shall be issued The department revokes the licenses it has obtained, and imposes a fine of 50,000 yuan up to 100,000 yuan, and will not accept applications for medical device licenses submitted by relevant responsible persons and units within 5 years.
Anyone who forges, alters, sells, leases, or lends relevant medical device licenses shall be confiscated or revoked by the original license-issuing department, and the illegal income shall be confiscated; if the illegal income is less than 10,000 yuan, a fine of 10,000 yuan up to 30,000 yuan shall be imposed; If the illegal income is more than 10,000 yuan, a fine of 3 times to 5 times of the illegal income shall be imposed; if it constitutes a violation of public security management, the public security organ shall impose public security management penalties in accordance with the law.
Article 65 Those who fail to file in accordance with these regulations shall be ordered by the food and drug regulatory department of the people’s government at or above the county level to make corrections within a time limit; if they fail to make corrections within the time limit, they shall announce the names of the unrecorded units and products to the public and may impose a fine of less than 10,000 yuan .
If false information is provided during the filing, the food and drug regulatory department of the people's government at or above the county level shall announce the name of the filing unit and product to the public; if the circumstances are serious, the person directly responsible shall not engage in the production and operation of medical devices within 5 years.
Article 66: In any of the following circumstances, the food and drug regulatory department of the people’s government at or above the county level shall order corrections and confiscate medical devices illegally produced, operated or used; the value of the medical devices illegally produced, operated or used is insufficient If the value of the goods is more than 10,000 yuan, a fine of more than 20,000 yuan and less than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of 5 times to 10 times the value of the goods shall be imposed; if the circumstances are serious, production and business shall be suspended until the original The license issuing department revokes the medical device registration certificate, medical device production license, and medical device business license:
(1) Manufacturing, operating, or using medical devices that do not meet mandatory standards or do not meet the technical requirements of registered or filed products;
(2) The medical device manufacturer fails to organize production in accordance with the registered or filed product technical requirements, or fails to establish a quality management system and maintain effective operation in accordance with these regulations;
(3) Operating or using medical devices that do not have conformity certificates, expired, invalidated, or eliminated, or use medical devices that are not legally registered;
(4) After the food and drug regulatory authority has ordered it to implement a recall or cease operations in accordance with these regulations, it still refuses to recall or cease operations of medical devices;
(5) Entrusting an enterprise that does not meet the requirements of these regulations to produce medical devices, or failing to manage the production activities of the entrusted party.
Medical device operating companies and users have fulfilled the obligations of purchase inspection and other requirements stipulated in these regulations, and have sufficient evidence to prove that they do not know that the medical devices they operate and use are medical devices under the conditions specified in the first and third items of the preceding paragraph, and can Those who truthfully state the source of their purchases can be exempted from punishment, but the medical devices they operate and use that do not meet the legal requirements shall be confiscated according to law.
Article 67 In any of the following circumstances, the food and drug regulatory department of the people’s government at or above the county level shall order corrections and impose a fine of 10,000 yuan up to 30,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business until the original certificate is issued Department revokes medical device production license and medical device business license:
(1) The production conditions of the medical device manufacturer have changed, no longer meet the requirements of the medical device quality management system, and fail to rectify, stop production, and report in accordance with the provisions of these regulations;
(2) Medical devices whose production and operation manuals and labels do not conform to the provisions of these regulations;
(3) The medical device is not transported and stored in accordance with the requirements of the medical device manual and label;
(4) Transfer of medical devices in use that are expired, invalid, obsolete or unqualified.
Article 68: In any of the following circumstances, the food and drug regulatory department and the health and family planning department of the people's government at or above the county level shall order corrections and give warnings according to their respective duties; if they refuse to make corrections, they shall be fined RMB 5,000 to RMB 20,000 Fine; if the circumstances are serious, it shall be ordered to suspend production and business until the original issuing department revokes the medical device production license and medical device business license:
(1) The medical device manufacturer fails to submit the quality management system self-inspection report as required;
(2) Medical device operating enterprises and user units fail to establish and implement the medical device purchase inspection record system in accordance with these regulations;
(3) Business enterprises engaged in the second and third category medical device wholesale business and the third category medical device retail business fail to establish and implement a sales record system in accordance with the provisions of these regulations;
(4) The reusable medical device is not handled by the medical device user unit in accordance with the regulations on disinfection and management;
(5) Medical device users reuse single-use medical devices, or fail to destroy used single-use medical devices in accordance with regulations;
(6) For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, the medical device user fails to inspect, inspect, calibrate, maintain, and maintain and record in accordance with the requirements of the product manual, analyze and evaluate in time to ensure that the medical device In good condition
(7) The medical device user fails to properly preserve the original materials of the third-class medical devices purchased, or fails to record the information of large-scale medical devices and implantable and interventional medical devices in relevant records such as medical records in accordance with regulations;
(8) The medical device user discovers that the medical device used has a potential safety hazard and fails to immediately stop using it, notify it for maintenance, or continue to use the medical device that cannot meet the safety standards after the maintenance;
(9) Medical device users use large-scale medical equipment in violation of regulations and cannot guarantee medical quality and safety;
(10) Medical device manufacturers and users fail to carry out medical device adverse event monitoring in accordance with these regulations, fail to report adverse events in accordance with requirements, or conduct adverse event investigations into medical device adverse event monitoring technical institutions and food and drug regulatory authorities Not to cooperate.
Article 69 Anyone who conducts clinical trials of medical devices in violation of these regulations shall be ordered by the food and drug regulatory department of the people’s government at or above the county level to make corrections or immediately stop the clinical trials, and a fine of less than 50,000 yuan may be imposed; if serious consequences are caused, the The directly responsible person in charge and other directly responsible persons shall be degraded, dismissed or expelled; the institution shall not conduct clinical trials of relevant professional medical devices within 5 years.
If a medical device clinical trial institution issues a false report, the food and drug supervision and administration department of the people’s government at or above the county level shall impose a fine of 50,000 yuan to 100,000 yuan; if there are illegal gains, the illegal gains shall be confiscated; Responsible personnel shall be dismissed or expelled in accordance with the law; the institution shall not conduct clinical trials of relevant professional medical devices within 10 years.
Article 70 If a medical device inspection agency issues a false inspection report, the competent authority that granted it will revoke the inspection qualification, and will not accept its qualification accreditation application within 10 years; impose a fine of 50,000 yuan up to 100,000 yuan; if there are illegal gains, Confiscation of illegal income; the directly responsible person in charge and other directly responsible personnel shall be dismissed or expelled according to law; those who are expelled shall not be engaged in medical device inspection work within 10 years from the date of the sanction decision.
Article 71 In violation of the provisions of these Regulations, the publication of medical device advertisements that have not obtained approval documents, the publication of medical device advertisements without prior verification of the authenticity of the approval documents, or the publication of medical device advertisements whose contents are inconsistent with the approval documents shall be subject to the The administrative department shall impose penalties in accordance with the relevant laws and administrative regulations on advertising management.
If the content of an approved medical device advertisement is tampered with, the original license-issuing department shall revoke the advertisement approval document for the medical device, and its advertisement approval application will not be accepted within 2 years.
If a false medical device advertisement is published, the food and drug regulatory authority of the people's government at or above the provincial level shall decide to suspend the sale of the medical device and announce it to the public; if the medical device is still being sold, the food and drug regulatory authority of the people's government at or above the county level shall confiscate the illegal For the sale of medical equipment, a fine of 20,000 yuan up to 50,000 yuan shall be imposed.
Article 72: If medical device technical review institutions and medical device adverse event monitoring technical institutions fail to perform their duties in accordance with the provisions of these Regulations, causing major errors in review and monitoring, the food and drug regulatory department of the people’s government at or above the county level shall order it Make corrections, circulate criticisms, and give warnings; if serious consequences are caused, the directly responsible person in charge and other directly responsible persons shall be degraded, dismissed or expelled according to law.
Article 73 The food and drug supervision and administration department, the health and family planning department and their staff shall strictly follow the types and ranges of punishments stipulated in these regulations, and exercise the power of administrative punishment according to the nature and specific circumstances of the violation. The specific measures shall be determined by the State Council Food and Drug Administration. The supervision and management department and the health and family planning department shall make decisions based on their respective responsibilities.
Article 74: In violation of the provisions of these regulations, the food and drug regulatory department of the people’s government at or above the county level or other relevant departments failing to perform their duties in the supervision and management of medical devices or abuse of power, negligence of duty, or malpractice for personal gains shall be directly responsible for the supervision agency or the appointment and removal agency The person in charge and other directly responsible personnel shall be given warnings, demerits or major demerits in accordance with the law; if serious consequences are caused, they shall be degraded, dismissed or expelled.
Article 75 Anyone who violates the provisions of these Regulations and constitutes a crime shall be investigated for criminal responsibility in accordance with the law; those who cause personal, property or other damage shall be liable for compensation in accordance with the law.
Chapter 8 Attached Rules
Article 76 The meaning of the following terms in these regulations:
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software; its utility is mainly obtained through physical methods, etc. It is not obtained through pharmacology, immunology or metabolism, or although these methods are involved but only play a supporting role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from the human body.
A medical device user unit refers to an institution that uses medical devices to provide medical treatment and other technical services to others, including medical institutions that have obtained a medical institution practice license, family planning technical service institutions that have obtained a family planning technical service agency license, and Blood stations, plasma collection stations, rehabilitation assistive device adaptation institutions, etc. that need to obtain a medical institution license.
Large-scale medical equipment refers to large-scale medical equipment with complex technology, large capital investment, high operating cost, large impact on medical expenses and included in catalog management.
Article 77 A fee 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 state regulations.
Article 78 The non-profit contraceptive medical device management methods and the management methods of medical devices developed by medical and health institutions to respond to public health emergencies shall be formulated by the Food and Drug Administration of the State Council in conjunction with the health and family planning department of the State Council.
Regulations for the management of Chinese medicine medical devices shall be formulated by the Food and Drug Administration of the State Council in conjunction with the Chinese Medicine Administration of the State Council in accordance with the provisions of these Regulations; the scope of medical devices for rehabilitation aids and their management measures shall be formulated by the Food and Drug Administration of the State Council in conjunction with the State Council The department is formulated in accordance with the regulations.
Article 79: The supervision and management of the use of military medical devices shall be organized and implemented by the military health authorities in accordance with these regulations and relevant military regulations.
Article 80 These regulations shall come into force on June 1, 2014.
