The "Administrative Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events" have been reviewed and approved by the State Administration for Market Regulation and the National Health Commission, and are hereby promulgated and will come into force on January 1, 2019.
Director of the State Administration for Market Regulation: Zhang Mao
Director of the National Health Commission: Ma Xiaowei
August 13, 2018
Medical device adverse event monitoring and re-evaluation management measures
Chapter 1 General
Article 1 In order to strengthen the monitoring and re-evaluation of adverse events of medical devices, timely and effectively control the risks of medical devices after they are on the market, and protect human health and life safety, these measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.
Article 2 These Measures shall apply to the monitoring, re-evaluation and supervision and management of medical device adverse events within the territory of the People's Republic of China.
Article 3 The holder of the medical device marketing license (hereinafter referred to as the holder) shall have the quality management capabilities and corresponding responsibilities to ensure the safety and effectiveness of the medical device, establish a medical device adverse event monitoring system, and report to the medical device adverse event monitoring technical institution (Hereinafter referred to as the monitoring agency) directly report adverse events of medical devices. Business enterprises and medical device users authorized to sell by the holder shall report adverse events of medical devices to the holder and the monitoring agency.
The holder shall evaluate the adverse events discovered, improve the quality of the product based on the evaluation results, and report the evaluation results and quality improvement measures to the monitoring agency; if the original registration authority is required for approval, an application shall be submitted in accordance with the regulations.
The agent designated by the overseas holder shall undertake the monitoring of the adverse events of imported medical devices sold in China and cooperate with the overseas holder to perform the re-evaluation obligation.
Article 4 The meaning of the following terms in these Measures:
(1) The holder of the medical device marketing authorization refers to the holder of the medical device registration certificate and the medical device filing certificate, that is, the medical device registrant and the filing person.
(2) Adverse events of medical devices refer to various harmful events that occur under normal use of medical devices that have been on the market and cause or may cause harm to the human body.
(3) Serious injury refers to one of the following conditions:
1. Life-threatening;
2. Cause permanent damage to body functions or permanent damage to body structure;
3. Medical measures must be taken to avoid the above-mentioned permanent injuries or injuries.
(4) Group medical device adverse events refer to events that occur in a relatively concentrated time and area during the use of the same medical device and cause damage or threat to the health or life safety of a certain number of people.
(5) Medical device adverse event monitoring refers to the process of collection, reporting, investigation, analysis, evaluation and control of medical device adverse events.
(6) The key monitoring of medical devices refers to the staged monitoring activities that are actively carried out to study the risk situation, characteristics, severity, and incidence of a certain product or product after it is marketed.
(7) Re-evaluation of medical devices refers to the process of re-evaluating the safety and effectiveness of medical devices that have been registered or filed and marketed, and taking corresponding measures.
Article 5 The State Drug Administration shall establish a national medical device adverse event monitoring information system and strengthen the construction of a medical device adverse event monitoring information network and database.
The monitoring agency designated by the State Drug Administration (hereinafter referred to as the national monitoring agency) is responsible for the unified management of the collected medical device adverse event information, and feedback of the medical device adverse event to the relevant monitoring agency, holder, operating company or user unit Monitor related information.
The monitoring information related to product use risks should be reported to the health administration department.
Article 6 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a medical device adverse event monitoring system, improve relevant systems, allocate corresponding monitoring institutions and personnel, and carry out medical device adverse event monitoring.
Article 7 Any unit or individual who discovers an adverse event of a medical device shall have the right to report to the department in charge of drug supervision and management (hereinafter referred to as the drug supervision and management department) or monitoring agency.
Chapter II Responsibilities and Obligations
Article 8 The National Medical Products Administration is responsible for the supervision and management of the national medical device adverse event monitoring and re-evaluation, and, in conjunction with the health administration department of the State Council, organizes the nationwide group medical devices that have a large impact and cause serious injuries or deaths and other serious consequences For the investigation and handling of adverse events, emergency control measures shall be taken in accordance with the law.
Article 9 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and management of the monitoring and re-evaluation of medical device adverse events in their administrative regions, and organize the development of mass medical devices that occur in their administrative regions in conjunction with the health administrative departments at the same level and relevant departments. For the investigation and handling of adverse events, emergency control measures shall be taken in accordance with the law.
The district-divided municipal and county-level drug supervision and administration departments are responsible for the monitoring of medical device adverse events in their respective administrative regions.
Article 10 The higher-level drug regulatory authority shall guide and supervise the lower-level drug regulatory authority to carry out the supervision and management of medical device adverse event monitoring and re-evaluation.
Article 11 The health administrative department of the State Council and local health administrative departments at all levels are responsible for the supervision and management of medical device use units related to the monitoring of medical device adverse events, supervise medical device use units to carry out medical device adverse event monitoring related work and organize inspections, Strengthen the assessment of the monitoring of medical device adverse events, and take relevant control measures for medical device adverse events within the scope of responsibility.
The higher-level health administrative department guides and supervises the lower-level health administrative department to carry out the supervision and management work related to the monitoring of medical device adverse events.
Article 12 The national monitoring agency is responsible for receiving medical device adverse event information reported by holders, operating companies, and users, and undertaking national medical device adverse event monitoring and re-evaluation related technical work; responsible for national medical device adverse event monitoring information Network and database construction, maintenance and information management, organize the formulation of technical specifications and guidelines, organize the investigation, evaluation and feedback of information related to adverse events of medical devices approved and registered by the National Medical Products Administration, and supervise and manage local drugs at and above the city level The department approves the registration or filing of medical device adverse event information to summarize, analyze and guide, and carry out the investigation and evaluation of the group medical device adverse events that have a large impact and cause serious injuries or deaths and other serious consequences nationwide.
Article 13 The monitoring agency designated by the drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government (hereinafter referred to as the provincial monitoring agency) organizes the technical work related to the monitoring and re-evaluation of medical device adverse events in the administrative area; undertaking registration or re-evaluation in the administrative area The investigation, evaluation and feedback of the recorded medical device adverse events, and the investigation and evaluation of the group medical device adverse events that occurred in the administrative area.
The municipal and county-level monitoring agencies with districts assist in the technical work related to the monitoring of medical device adverse events in the administrative area.
Article 14 The holder shall conduct continuous research on the medical devices on the market, evaluate the risk, assume the responsibility of monitoring the adverse events of the medical device, take effective control measures based on the analysis and evaluation results, and perform the following main obligations:
(1) Establish a medical device quality management system that includes a medical device adverse event monitoring and re-evaluation system;
(2) Equipped with institutions and personnel suitable for its products to engage in medical device adverse event monitoring related work;
(3) Actively collect and report medical device adverse events to the monitoring agency in a timely manner in accordance with the time limit specified in these Measures;
(4) Conduct timely investigation, analysis, and evaluation of medical device adverse events, take measures to control risks, and release risk information in a timely manner;
(5) Conduct continuous research on the safety of listed medical devices, and write regular risk evaluation reports as required;
(6) Actively carry out re-evaluation of medical devices;
(7) Cooperate with the adverse event investigation organized by the drug regulatory authority and monitoring agency.
Article 15 In addition to fulfilling the obligations stipulated in Article 14 of these Measures, overseas holders shall also establish an information transmission mechanism with their designated agents to exchange information related to medical device adverse event monitoring and re-evaluation in a timely manner.
Article 16 Medical device operating enterprises and users shall perform the following main obligations:
(1) Establish a monitoring system for medical device adverse events of the unit, and medical institutions should also incorporate the monitoring of medical device adverse events into the key work of quality and safety management of medical institutions;
(2) Equipped with institutions or personnel suitable for the scale of operation or use of medical devices to conduct work related to the monitoring of medical device adverse events;
(3) Collect medical device adverse events, report to the holder in time, and report to the monitoring agency as required;
(4) Cooperate with the holder in the investigation, evaluation and re-evaluation of medical device adverse events;
(5) Cooperate with the adverse event investigation organized by the drug regulatory authority and monitoring agency.
Chapter III Report and Evaluation
Section 1 Basic Requirements
Article 17 Reporting of medical device adverse events should follow the principle of reporting if they are suspicious, that is, when an event is suspected of being a medical device adverse event, it can be reported as a medical device adverse event.
The content of the report should be true, complete and accurate.
Article 18 Suspicious medical device adverse events that cause or may cause serious injury or death should be reported; innovative medical devices should report all medical device adverse events of the product during the first registration cycle.
Article 19 Holders, operating companies, and second-level or higher medical institutions shall register as users of the National Medical Device Adverse Event Monitoring Information System, actively maintain their user information, and report medical device adverse events. The holder should continue to track and process the monitoring information; if the product registration information changes, it should be updated in the system immediately.
Encourage other users to register as users of the National Medical Device Adverse Event Monitoring Information System and report information about adverse events.
Article 20 The holder shall publish contact information such as telephone number, mailing address, email address, fax, etc., designate a contact person, and actively collect information on adverse events from medical device business enterprises, users, users, etc.; For medical device adverse events, the holder shall directly report and evaluate the medical device adverse event through the National Medical Device Adverse Event Monitoring Information System, and report the group medical device adverse event investigation report and regular risk evaluation report.
If a medical device operating enterprise or user unit discovers or learns of a suspicious medical device adverse event, it shall promptly notify the holder and report it through the National Medical Device Adverse Event Monitoring Information System. Those who do not have the online reporting requirements for the time being shall report to the local monitoring agency at or above the county level through paper reports, and the monitoring agency shall report online on its behalf.
Monitoring agencies at all levels shall publish contact information such as telephone numbers and correspondence addresses.
Article 21 The holder shall analyze and evaluate the collected and learned medical device adverse event monitoring information, and actively carry out medical device safety research. For medical devices approved with conditions, the holder shall also carry out relevant work in accordance with the risk control plan.
Article 22 Holders, operating enterprises, and user units shall establish and keep medical device adverse event monitoring records. Records should be kept for 2 years after the validity of the medical device; if there is no validity period, the retention period shall not be less than 5 years. The monitoring records of implantable medical devices shall be kept permanently, and medical institutions shall keep them in accordance with the relevant regulations on cases.
Article 23 Provincial-level monitoring agencies shall conduct a comprehensive analysis of the adverse event reports of medical devices registered or filed in their administrative regions, and propose regulatory measures for the risks discovered, and report to the province, autonomous region, or region where they are located within 30 days after the end of each quarter. Municipal drug supervision and administration departments and national monitoring agencies.
The national monitoring agency shall conduct a comprehensive analysis of the adverse event reports of medical devices approved for registration or filing by the State Drug Administration and the quarterly reports of the drug regulatory authorities of the provinces, autonomous regions, and municipalities directly under the Central Government, and make recommendations on regulatory measures to the State Drug Administration when necessary .
Article 24 Provincial-level monitoring agencies shall conduct a summary analysis of the adverse event monitoring of medical devices registered or filed in their administrative area on an annual basis, and form an annual summary report, which shall be reported to the local province, autonomous region, or municipality before March 15 each year. Supervision and management departments and national monitoring agencies.
The national monitoring agency shall summarize and analyze the annual monitoring of adverse events of medical devices nationwide, and form an annual report, which shall be submitted to the State Drug Administration by the end of March each year.
The drug supervision and administration department at or above the provincial level shall report the annual report to the health administration department at the same level.
Section 2 Cases of Adverse Events of Medical Devices
Article 25 If the holder discovers or learns of a suspicious medical device adverse event, he should investigate the cause immediately. If it causes death, it should be reported within 7 days; if it causes serious injury, may cause serious injury or death, it should be reported within 20 days.
Medical device operating enterprises or user units shall promptly notify the holder if they discover or learn of suspicious medical device adverse events. Among them, the cause of death should also be reported within 7 days, and the cause of serious injury, may cause serious injury or death within 20 days, through the National Medical Device Adverse Event Monitoring Information System.
Article 26. Units and individuals other than holders, operating enterprises, and users who discover adverse events of medical devices that cause or may cause serious injury or death may report to the monitoring agency, or to the holder, Reports from operating enterprises or medical institutions under treatment, and provide relevant medical records when necessary.
Article 27 Overseas holders of imported medical devices and holders of domestically-produced medical devices sold overseas shall take the initiative to collect adverse medical device incidents of their products abroad. Among them, if it causes or is likely to cause serious injury or death, the agent designated by the overseas holder and the holder of the domestic medical device shall report it within 30 days from the date of discovery or knowledge.
Article 28 The municipal monitoring agency with districts shall review the authenticity, completeness and accuracy of the report within 10 days from the date of receipt of the medical device adverse event report, and provide real-time feedback to the relevant holders.
Article 29 After the holder reports an adverse event of a medical device or learns of the relevant medical device adverse event through the National Medical Device Adverse Event Monitoring Information System, he shall carry out follow-up investigation, analysis and evaluation as required. The event leading to death shall be Within 30 days, an event that causes serious injury, may cause serious injury or death should report the evaluation result to the provincial monitoring agency where the holder is located within 45 days. If there are new discoveries or cognitions about the event situation and evaluation results, a supplementary report shall be made.
Article 30 The provincial monitoring institution where the holder is located shall complete the review of the evaluation results within 10 days of receiving the holder’s evaluation results. If necessary, it may entrust or cooperate with the provincial monitoring institution in the place where the adverse event occurred to investigate the cause or may cause serious Conduct on-site investigations of adverse events of injury or death. Among them, for medical devices approved and registered by the State Drug Administration, the national monitoring agency shall also review the evaluation and review results made by the provincial monitoring agency, and may organize investigations into adverse events leading to death when necessary.
The audit and review results should be reported back to the holder. If there are objections to the evaluation results of the holder, the holder may be required to re-evaluate.
Section 3 Group Adverse Events of Medical Devices
Article 31: After the holder, operating enterprise, or user unit discovers or learns about the adverse event of a group medical device, they shall report the adverse event by telephone or fax within 12 hours, and the drug regulatory authority of the province, autonomous region, or municipality where the adverse event occurred The health administration department can report by skipping levels when necessary, and at the same time report the basic information of the group's medical device adverse events through the National Medical Device Adverse Event Monitoring Information System, and each event should be reported on a case by case basis within 24 hours.
The drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government where the adverse event occurred shall promptly notify the drug regulatory authority of the province, autonomous region, or municipality where the holder is located.
Article 32 After the holder discovers or learns of the adverse events of the mass medical device of his product, he shall immediately suspend production and sales, notify the user to stop using the relevant medical device, and carry out investigation and self-inspection of the production quality management system at the same time. Report to the drug supervision and administration department and monitoring agency of the province, autonomous region, and municipality where the adverse event occurred within 7 days.
The investigation should include the product quality status, the relationship between the injury and the product, the compliance of the use link operation and the circulation process, etc. Self-inspection shall include procurement, production management, quality control, and tracking of products of the same model and batch, etc.
The holder should analyze the cause of the incident, release risk information in a timely manner, report the self-inspection and the control measures taken to the locality and the drug regulatory authority of the province, autonomous region, and municipality where the adverse event occurred, and should recall the relevant medical devices when necessary.
Article 33: Medical device operating companies and user units that discover or learn of group medical device adverse events shall notify the holders within 12 hours, carry out self-examination quickly, and cooperate with the holders in the investigation. The self-inspection should include product storage and circulation process traceability, the same model and batch product tracking, etc.; the user's self-inspection should also include whether the use process complies with the operating specifications and product instructions. When necessary, medical device operating companies and user units shall suspend the sale and use of medical devices and assist relevant units in taking relevant control measures.
Article 34 After the drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are informed of the group medical device adverse events that have occurred in their administrative areas, they shall, in conjunction with the health administrative departments at the same level, conduct on-site investigations in a timely manner. The department should cooperate. The results of investigation, evaluation and handling shall be reported to the State Drug Administration and the health administration department of the State Council in a timely manner, and a copy shall be sent to the drug administration department of the province, autonomous region, or municipality where the holder is located.
Article 35 For group medical device adverse events that have a large national impact and cause serious injuries or deaths and other serious consequences, the State Drug Administration shall organize investigations and handling in conjunction with the health administration department of the State Council. The national monitoring agency is responsible for on-site investigations, and the drug regulatory departments and health administrative departments of relevant provinces, autonomous regions, and municipalities shall cooperate.
The investigation content should include the occurrence of medical device adverse events, medical device use, patient diagnosis and treatment, previous similar adverse events, product production process, product storage and circulation, and tracking of products of the same model and batch.
Article 36 The national monitoring agency, the drug supervision and administration department and the health administration department of the relevant provinces, autonomous regions, and municipalities directly under the Central Government shall, within 5 days after the investigation is completed, carry out technical evaluations of product risks and put forward control measures recommendations based on the investigation results, and form an investigation report. The State Drug Administration and the health administration department of the State Council.
Article 37 The drug regulatory department of the province, autonomous region, or municipality where the holder is located may conduct on-site inspections of the holders involved in group adverse events. When necessary, the State Drug Administration may conduct on-site inspections of foreign holders involved in group adverse events.
The on-site inspection shall include the operation of the production quality management system, product quality status, production process, tracking of products of the same model and batch, etc.
Section 4 Periodic Risk Evaluation Report
Article 38 The holder shall conduct continuous research on the safety of listed medical devices, summarize and analyze the adverse event reports, monitoring data and domestic and foreign risk information of the product, evaluate the risks and benefits of the product, and record the risks taken Control measures and write regular risk evaluation reports after listing.
Article 39 The holder shall complete the periodical risk evaluation report of the previous year’s product after the launch of the product within 60 days from the date of first approval of registration or filing of the product. Among them, those registered by the State Drug Administration shall be submitted to the national monitoring agency; those registered by the drug regulatory agency of a province, autonomous region, or municipality directly under the Central Government shall be submitted to the local provincial monitoring agency. The periodic risk evaluation report of the first class medical device shall be kept by the holder for future reference.
For medical devices that have obtained renewal of registration, the periodic risk evaluation report of this registration cycle shall be completed at the next renewal application, and the holder shall keep it for future reference.
Article 40 Monitoring agencies at or above the provincial level shall organize the review of the regular risk assessment reports received after the medical device products are on the market. When necessary, the review opinions shall be fed back to the holder.
Article 41 The provincial monitoring agency shall conduct a comprehensive analysis of the regular post-marketing risk evaluation report received, and report the statistics and analysis and evaluation results of the previous year’s post-marketing regular risk evaluation report to the national monitoring agency before May 1 of each year. And the drug supervision and administration department of the province, autonomous region, and municipality where it is located.
The national monitoring agency shall conduct a comprehensive analysis of the statistics and analysis evaluation results of the received periodic risk assessment reports after listing and the reports submitted by provincial monitoring agencies, and the statistics of the periodic risk assessment reports of the previous year after listing shall be made before July 1 of each year. And the analysis and evaluation results are reported to the State Drug Administration.
Chapter IV Key Monitoring
Article 42 Drug regulatory authorities at or above the provincial level may organize key monitoring of medical devices and strengthen post-market risk research on medical device products.
Article 43 The State Drug Administration, in conjunction with the health administration department of the State Council, determines the key types of medical devices to be monitored, organizes the formulation of key monitoring work plans, and supervises their implementation.
The key national medical device monitoring products shall be determined based on the medical device registration, adverse event monitoring, supervision and inspection, inspection, etc., combined with the product risk level and use status.
The national monitoring agency organizes and implements the key monitoring of medical devices and completes the relevant technical reports. The drug supervision and administration department may take necessary management measures based on the risks found in the monitoring.
Article 44 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government may, according to the needs of medical device supervision in their own administrative regions, refer to the provisions of Article 43 of these Measures, to register the second category and the first category registered in the administrative region. Medical devices carry out the key monitoring work of provincial medical devices.
Article 45 The holders involved in the key monitoring varieties of medical devices shall carry out work in accordance with the requirements of the key monitoring work plan for medical devices, actively collect the adverse event reports of their products and other related risk information, write risk evaluation reports, and report them as required. Send to the key monitoring organization department.
Article 46 Drug supervision and administration departments at or above the provincial level may designate units with certain conditions as monitoring sentinels to actively collect key monitoring data. The monitoring sentinel shall provide the use of the key monitored varieties of medical devices, actively collect and report adverse event monitoring information, organize or recommend relevant experts to carry out or cooperate with the monitoring agency to carry out scientific research related to risk assessment.
Article 47 Innovative medical device holders shall strengthen the active monitoring of innovative medical devices, formulate product monitoring plans, actively collect relevant adverse event reports and product complaint information, and conduct investigations, analysis, and evaluation.
Innovative medical device holders shall submit a summary report of product adverse event monitoring analysis and evaluation to the national monitoring agency every six months during the first registration cycle. If the national monitoring agency finds information about possible serious defects in medical devices, it shall promptly report to the State Drug Administration.
Chapter 5 Risk Control
Article 48 If the holder discovers medical devices with unreasonable risks that may endanger human health and life safety through the monitoring of medical device adverse events, they shall take the following risk control measures according to the situation and report to the province, autonomous region, or municipality where they are located. Supervision and management department:
(1) Stop production and sales of related products;
(2) Notify medical device operators and users to suspend sales and use;
(3) Implement product recall;
(4) Release risk information;
(5) Self-inspection of the production quality management system and rectification of related issues;
(6) Modify instructions, labels, operation manuals, etc.;
(7) Improve production technology, design, product technical requirements, etc.;
(8) Carry out re-evaluation of medical devices;
(9) Change registration or filing as required;
(10) Other risk control measures that need to be taken.
The holders shall promptly announce to the public the risks related to the safety of the use of machinery and their disposal.
Article 49 If the drug regulatory authority believes that the control measures taken by the holder are not sufficient to effectively prevent risks, it may issue warning messages, suspend production, sales and use, order recalls, require them to modify the instructions and labels, and organize re-evaluation. And other measures, and organize supervision and inspection of holders.
Article 50 For medical devices that have experienced group medical device adverse events, the drug supervision and administration department at or above the provincial level may take control measures such as suspension of production, sales, and use according to the risk situation, organize supervision and inspection of the holders, and promptly report The society issues warnings and disposal information. After the conclusion of the technical evaluation is reached, the drug supervision and administration department at or above the provincial level shall, in accordance with the requirements of relevant regulations, take further regulatory measures and strengthen the monitoring of adverse events of similar medical devices.
The health administrative department at the same level shall suspend the use of relevant medical devices in medical institutions within its administrative area, and take measures to actively organize the treatment of patients. The relevant holders should cooperate.
Article 51 Monitoring institutions at or above the provincial level have discovered that medical devices are inconsistent in the process of evaluation and review of medical device adverse event reports, quarterly and annual summary analysis of adverse event reports, group adverse event evaluation, key monitoring, and periodic risk evaluation reports. If there is a reasonable risk, risk management opinions shall be put forward, and timely feedback to the holder and report to the corresponding drug regulatory authority. Provincial-level monitoring agencies should also report to national monitoring agencies.
The holder shall formulate and implement corresponding risk control measures based on the risk management opinions received.
Article 52 When necessary, drug regulatory authorities and health administrative departments at all levels may entrust products involved in medical device adverse events to a medical device inspection agency with corresponding qualifications for inspection. The medical device inspection agency shall carry out relevant inspections in a timely manner and issue inspection reports.
Article 53 If an imported medical device has an adverse medical device event abroad, or a domestic medical device has an adverse medical device event abroad, and control measures are taken, the agent designated by the overseas holder or the holder of the domestic medical device shall Within 24 hours of being notified, report the adverse events of overseas medical devices, the control measures and the control measures to be taken in China to the State Drug Administration and the national monitoring agency, and send a copy to the local drug regulatory authority of the province, autonomous region, or municipality directly under the Central Government. Report the follow-up treatment in a timely manner.
Article 54 Suspicious medical device adverse events caused by the quality of medical device products shall be dealt with by the drug supervision and administration department in accordance with the relevant medical device regulations; if it is caused by the use of medical devices, the health administration department shall deal with it.
Chapter 6 Re-evaluation
Article 55 In any of the following circumstances, the holder shall take the initiative to carry out re-evaluation and take corresponding measures based on the conclusion of the re-evaluation:
(1) According to the development of scientific research, the understanding of the safety and effectiveness of medical devices has changed;
(2) The medical device adverse event monitoring and evaluation results indicate that the medical device may have defects;
(3) Other circumstances under which the State Drug Administration stipulates that re-evaluation should be carried out.
Article 56 When carrying out a medical device re-evaluation, the holder shall, based on the product safety and effective information, clinical data and use experience, etc., obtained and mastered after the product is marketed, review the summary data, research data, and clinical data in the original medical device registration data. The evaluation data, product risk analysis data, product technical requirements, manuals, labels and other technical data and content shall be re-evaluated.
Article 57 The re-evaluation report shall include product risk and benefit assessment, social and economic benefit assessment, technical progress assessment, and proposed measures and recommendations.
Article 58 If the holder takes the initiative to carry out re-evaluation of medical devices, it shall formulate a re-evaluation work plan. If it is determined through re-evaluation that control measures are needed, a re-evaluation report shall be submitted within 15 days after the conclusion of the re-evaluation is formed. Among them, the holders of medical devices approved by the State Drug Administration for registration or filing shall be submitted to the national monitoring agency; holders of other medical devices shall submit to the local provincial monitoring agency.
If the holder fails to perform the medical device re-evaluation obligations as required, the drug regulatory authority at or above the provincial level shall order the holder to carry out the re-evaluation. When necessary, the drug regulatory authority at or above the provincial level may directly organize the re-evaluation.
Article 59 If the drug regulatory authority at or above the provincial level orders the re-evaluation, the holder shall submit the re-evaluation plan and re-evaluation to the corresponding drug regulatory authority and monitoring agency before the re-evaluation is implemented and within 30 days after the re-evaluation is completed. report.
If the implementation period of the re-evaluation exceeds one year, the holder shall report the annual progress annually.
Article 60 The monitoring agency shall review the received re-evaluation report of the holder and report the review opinion to the corresponding drug regulatory authority.
If the drug regulatory authority disagrees with the conclusion of the re-evaluation carried out by the holder, the holder shall reconfirm the re-evaluation result or re-evaluate in accordance with the requirements of the drug regulatory authority.
Article 61: Where the drug regulatory authority organizes the re-evaluation of medical devices, the designated monitoring agency shall formulate the re-evaluation plan, and organize the implementation after the approval of the drug regulatory authority that organized the re-evaluation, and submit the re-evaluation report to the corresponding drug Supervision and management department reports.
Article 62 If the result of the re-evaluation shows that the registered or filed medical device has defects that endanger personal safety, and the risk cannot be eliminated or controlled by measures such as technical improvement, modification of instructions and labels, or the risk-benefit ratio is unacceptable. Someone should take the initiative to apply for cancellation of the medical device registration certificate or cancellation of the product filing; if the holder fails to apply for the cancellation of the medical device registration certificate or cancellation of the filing, the original issuing authority shall cancel the medical device registration certificate or cancel the filing. The drug supervision and administration department shall promptly announce to the public the relevant information on the cancellation of the medical device registration certificate or the cancellation of the record.
The State Drug Administration may, based on the conclusion of the re-evaluation, make a decision to eliminate medical device varieties. For products that have been eliminated, the medical device registration certificate or product filing shall be cancelled or cancelled by the original license-issuing department.
The medical device whose registration certificate has been cancelled or the registration has been cancelled shall not be produced, imported, operated or used.
Chapter VII Supervision and Management
Article 63 The drug regulatory authority shall supervise and inspect the monitoring and re-evaluation of medical device adverse events carried out by the holders and operating enterprises in accordance with their duties, and work with the health administrative department at the same level to conduct medical device adverse events on medical device users. Supervise and inspect the monitoring situation.
Article 64 The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall formulate medical device adverse event monitoring and inspection plans in their respective administrative regions, determine inspection priorities, and supervise implementation.
Article 65 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall strengthen the training and assessment of staff engaged in the monitoring and re-evaluation of medical device adverse events within their respective administrative regions.
Article 66 The drug supervision and administration department shall, in accordance with the requirements of laws, regulations, and norms, supervise and inspect the establishment of the holder's adverse event monitoring system and work development. When necessary, an extended inspection may be carried out on the enterprise entrusted by the holder to carry out related work.
Article 67 In any of the following circumstances, the drug regulatory authority shall conduct key inspections on the holder:
(1) Failure to actively collect and report medical device adverse events in accordance with the time limit;
(2) There is a large gap between the number of adverse events reported by the holder that caused or may cause serious injury or death and the number of reports from medical institutions, indicating that its main responsibility has not been implemented;
(3) Concealing, under-reporting, or false reporting;
(4) Failing to cooperate with the investigation of medical device adverse events conducted by the drug regulatory authority and the control measures taken;
(5) Failing to collect product safety information through adverse event monitoring as required, or failing to conduct post-marketing research and re-evaluation as required, which cannot guarantee the safety and effectiveness of the product.
Article 68 The holder fails to establish an adverse event monitoring system as required, conducts adverse event monitoring and re-evaluation related work, fails to take effective risk control measures in a timely manner in accordance with Article 48 of these Measures, and fails to cooperate with the drug regulatory authority In the case of investigations related to medical device adverse events and control measures taken, the drug regulatory authority may require them to stop production for rectification, and take control measures to stop product sales when necessary.
If it is necessary to resume production and sales, the holder shall submit an application to the drug regulatory authority that made the decision, and the drug regulatory authority shall make a decision to resume production and sales after passing the on-site inspection.
Before the holder submits an application for resuming production and sales, he can hire an independent third-party professional organization with corresponding qualifications to check and confirm.
Article 69 The drug supervision and administration department at or above the provincial level uniformly releases the following monitoring information on medical device adverse events:
(1) Group medical device adverse events related information;
(2) Medical device adverse event monitoring warning information;
(3) Medical device adverse event monitoring information that needs to be regularly released;
(4) Other medical device adverse event monitoring information that needs to be released uniformly.
Chapter 8 Legal Liability
Article 70 If the holder has any of the following circumstances, in accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Devices, the drug regulatory authority at or above the county level shall order corrections and give warnings; if they refuse to make corrections, they shall be punished A fine of not less than 5,000 yuan but not more than 20,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business until the relevant certification documents are revoked by the issuing department:
(1) Failure to actively collect and report medical device adverse events in accordance with the time limit;
(2) Concealing, under-reporting, or false reporting;
(3) Failure to report the evaluation results according to the time limit or submit a group medical device adverse event investigation report;
(4) Failing to cooperate with the investigation of medical device adverse events and the control measures taken by the drug regulatory authority and monitoring agency.
Article 71: If a medical device business enterprise or user unit has one of the following circumstances, in accordance with the provisions of Article 68 of the Regulations on the Supervision and Administration of Medical Devices, the drug supervision and administration department at or above the county level and the health administrative department shall, in accordance with their respective duties Order corrections and give warnings; if they refuse to make corrections, a fine of not less than 5,000 yuan but not more than 20,000 yuan will be imposed; if the circumstances are serious, they will be ordered to suspend production and business until the relevant certification documents are revoked by the issuing department:
(1) Failure to actively collect and report medical device adverse events in accordance with the time limit;
(2) Concealing, under-reporting, or false reporting;
(3) Failing to cooperate with the investigation of medical device adverse events and the control measures taken by the drug regulatory authority and monitoring agency.
Article 72 If the holder fails to carry out re-evaluation as required, conceal the results of the re-evaluation, or should submit an application for cancellation but fails to submit it, the drug regulatory authority at or above the provincial level shall order corrections, give a warning, and impose a penalty of more than 10,000 yuan. Fines below 30,000 yuan.
Article 73 If the holder has one of the following circumstances, the drug regulatory authority at or above the county level shall order corrections and give warnings; if they refuse to make corrections, a fine of 5,000 yuan to 20,000 yuan shall be imposed:
(1) Failure to establish a medical device adverse event monitoring and re-evaluation system in accordance with regulations;
(2) Failing to allocate institutions and personnel suitable for its products as required to engage in medical device adverse event monitoring related work;
(3) The monitoring records of adverse events are not kept or the retention period is insufficient;
(4) Those who should be registered but not registered as users of the medical device adverse event monitoring information system;
(5) Failing to actively maintain user information, or failing to continuously track and process monitoring information;
(6) Failing to take corresponding control measures based on the adverse events and make them public;
(7) Failure to write, submit or retain the periodic risk evaluation report after listing as required;
(8) Failure to report adverse events of overseas medical devices and overseas control measures as required;
(9) Failure to submit a summary report on the analysis and evaluation of innovative medical device products as required;
(10) Failure to publish contact information and actively collect information on adverse events;
(11) Failure to carry out key monitoring of medical devices as required;
(12) Other violations of the regulations.
Article 74: If a medical device business enterprise or user unit has any of the following circumstances, the drug regulatory department and health administrative department at or above the county level shall order corrections and give warnings according to their respective duties; if they refuse to make corrections, a penalty of 5,000 yuan or more shall be imposed. 2 Fines below 10,000 yuan:
(1) Failing to establish a medical device adverse event monitoring system as required;
(2) Failing to allocate institutions or personnel commensurate with its business or use scale to engage in medical device adverse event monitoring related work;
(3) The monitoring records of adverse events are not kept or the retention period is insufficient;
(4) Should be registered but not registered as a user of the National Medical Device Adverse Event Monitoring Information System;
(5) Failure to promptly report the collected or learned medical device adverse events to the holder;
(6) Failure to cooperate with the holder in the investigation and evaluation of adverse events of medical devices;
(7) Other violations of the regulations.
If the drug supervision and administration department finds that the user unit has the behavior specified in the preceding paragraph, it shall transfer it to the health administrative department at the same level for handling.
If the health administrative department makes an administrative penalty decision on the user unit, it shall promptly notify the drug supervision and administration department at the same level.
Article 75: Where holders, operating enterprises, and user units report, investigate, evaluate, and dispose of medical device adverse events in accordance with the requirements of these Measures, and take the initiative to eliminate or reduce the harmful consequences, their related illegal acts shall be governed by the The Penalty Law provides for lighter or mitigated punishment. If the illegal act is minor and corrected in time, and does not cause harmful consequences, no punishment shall be imposed, but the other legal liabilities shall not be exempted.
Article 76: If the drug supervision and administration departments, health administration departments, monitoring agencies and their staff at all levels fail to perform their duties according to regulations, they shall comply with Articles 72 and 74 of the Regulations on the Supervision and Administration of Medical Devices. Provision to be processed.
Article 77 If the holder, operating enterprise, or user unit violates relevant regulations and causes damage to the medical device user, it shall be liable for compensation in accordance with the law.
Chapter 9 Supplementary Provisions
Article 78 The content of medical device adverse event reports, risk analysis and evaluation reports, and statistical data are the basis for strengthening the supervision and management of medical devices and guiding the rational use of medical devices, and shall not be used as the basis for medical disputes, medical litigation and handling medical device quality accidents .
For medical accidents or medical device quality problems, they shall be dealt with separately in accordance with the requirements of relevant laws and regulations.
Article 79 The State Drug Administration and the health administration department of the State Council are responsible for the interpretation of these measures.
Article 80 These Measures shall come into force on January 1, 2019.
