Medical Device Adverse Event Monitoring and Re-evaluation Management Measures (Trial) Article 1 In order to strengthen the medical device adverse event monitoring and re-evaluation work, according to the "Medical Device Supervision and Administration Regulations" to formulate these measures.
Article 2 These Measures shall apply to medical device manufacturers, business enterprises, use units, medical device adverse event monitoring technical institutions, food and drug supervision and management departments and other relevant authorities.
Article 3 The State encourages citizens, legal persons and other relevant social organizations to report adverse events of medical devices. Article 4 The State Food and Drug Administration is responsible for the monitoring and re-evaluation of adverse events of medical devices, and performs the following main duties: (1) in conjunction with the Ministry of Health to formulate regulations for the monitoring and re-evaluation of adverse events of medical devices and supervise the implementation of such regulations; (2) to organize and inspect the monitoring and re-evaluation of adverse events of medical devices in medical device manufacturers, business enterprises and use units, and in conjunction with the Ministry of Health to organize and inspect the monitoring and re-evaluation of medical devices in medical institutions. (C) in conjunction with the Ministry of Health to organize and coordinate the investigation and treatment of sudden, mass serious injury or death of adverse events; (D) the Ministry of Health to determine and release the key monitoring varieties of medical devices; (E) notify the national monitoring of medical devices and re-evaluation results; (F) according to the medical device adverse event monitoring and re-evaluation of the results (F) according to the medical device adverse event monitoring and re-evaluation results, according to law to take appropriate management measures.
Article V Provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration is responsible for the monitoring and re-evaluation of adverse events of medical devices in the administrative region, and to perform the following main duties: (1) to organize and inspect the medical device manufacturers, business enterprises and the use of medical devices in the administrative region to carry out monitoring and re-evaluation of adverse events of medical devices and, in conjunction with the competent department of health at the same level, to organize and inspect the medical and health care services in the administrative region. (a) Organize and inspect the monitoring and re-evaluation of medical device adverse events of medical device manufacturers, operators and users in the administrative region, and organize and inspect the monitoring and re-evaluation of medical device adverse events of medical device manufacturers, operators and users in the administrative region, and organize and inspect, together with the competent health department at the same level, the implementation of monitoring of medical device adverse events of medical device of medical and health institutions in the administrative region; (b) Organize, together with the competent health department at the same level, the investigation and handling of sudden, serious injury or death of adverse events of medical devices occurring within the administrative region (D) according to the medical device adverse event monitoring and re-evaluation results, according to law to take appropriate management measures.
Article 6 The Ministry of Health and local health departments at all levels shall be responsible for the management of medical and health institutions in relation to the implementation of the monitoring of adverse events of medical devices, and shall perform the following main duties: (1) to organize and inspect medical and health institutions to carry out monitoring of adverse events of medical devices; (2) to supervise and inspect the medical technologies and behaviors related to medical devices and take action against the medical technologies and behaviors with serious consequences in accordance with law. (B) the medical technology and behavior related to medical devices supervision and inspection, and to produce serious consequences of medical technology and behavior to take appropriate management measures; (C) coordinate the investigation of medical equipment adverse events occurring in health care institutions; (D) to produce serious consequences of medical devices in accordance with the law to take appropriate management measures.
Article 7 The National Center for Adverse Drug Reaction Monitoring is responsible for the monitoring and re-evaluation of adverse events of medical devices and performs the following main duties: (1) to be responsible for the collection of monitoring information on adverse events of medical devices, evaluation and feedback; (2) to be responsible for the re-evaluation of medical devices and related technical work; (3) to be responsible for the monitoring of medical devices and technical institutions of provinces, autonomous regions and municipalities directly under the central government (C) is responsible for the provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Organization for technical guidance; (D) bear the national medical device adverse event monitoring database and information network construction and maintenance work.
Article VIII Provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions shall undertake the monitoring and re-evaluation of medical device adverse events in the administrative region, and perform the following main duties: (1) to be responsible for the monitoring of medical devices in the administrative region of the collection of information, evaluation, feedback and reporting; (2) to be responsible for the approval of the food and drug supervision and management department of the administrative region within the domestic first and second class of medical devices listed on the market. (B) responsible for the food and drug supervision and management department within the administrative region approved the listing of the territory of the first and second class of medical devices re-evaluation of the relevant technical work. Article 9 The medical device manufacturers, operators and users shall establish a medical device adverse event monitoring management system, designated institutions and full-time (part-time) staff to undertake the monitoring of adverse events of medical devices. Medical device manufacturers, operators and users shall establish and maintain medical device adverse event monitoring records. Records should be kept until 2 years after the use of medical devices labeled, but the record retention period should be not less than 5 years. Adverse event monitoring records of medical devices, including the content of Annex 1 to 3 of these measures, and adverse events found, reported, evaluated and controlled the process of relevant documents and records.
Article X medical device manufacturers shall take the initiative to collect all the suspected medical device adverse events occurring in their products to the medical device business enterprises and the use of units, the medical device business enterprises and the use of units shall give cooperation. Enterprises producing Class II and Class III medical devices shall also establish a corresponding system to ensure the traceability of their products.
Article XI of the medical device manufacturers, business enterprises shall report the production and operation of medical devices involving their products occurring in the product leading to, or may lead to serious injury or death of the adverse events. The use of medical devices shall report the use of medical devices involved in the occurrence of medical devices or may lead to serious injury or death of the adverse events of medical devices. Reporting of adverse events of medical devices should follow the principle of suspicious that report.
Article XII of the medical device manufacturers, business enterprises and the use of units found or known to report adverse events of medical devices, should fill out the "Suspected Medical Device Adverse Event Report Form" (Annex 1) to the local provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Agency report. Among them, the events leading to death within 5 working days from the date of discovery or knowledge, the events leading to serious injury, may lead to serious injury or death within 15 working days from the date of discovery or knowledge of the report. Medical device business enterprises and the use of units in the local provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions report at the same time, should inform the relevant medical device manufacturers. Medical device manufacturers, business enterprises and use of units think necessary, can be reported to the next level, but should be promptly informed of the location of the province, autonomous region, municipality directly under the Central Medical Device Adverse Event Monitoring Technical Institutions.
Article XIII of the individual found that lead to or may lead to serious injury or death of the medical device adverse event, you can to the location of the province, autonomous region, municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions or to the location of the county level or above the food and drug supervision and management department to report. Above the county level food and drug supervision and management department receives individual reports of adverse events of medical devices report, shall promptly notify the local provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions.
Article XIV provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions shall promptly notify the relevant medical device manufacturer of the location of the provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions after receiving the adverse event report. Received the notice of the province, autonomous region, municipality directly under the Central Medical Device Adverse Event Monitoring Technical Institutions, shall supervise the administrative region of the medical device manufacturer to carry out the adverse event records, investigation, analysis, evaluation, treatment, reporting work.
Article 15 The medical device manufacturer shall, within 20 working days after the first report, fill in the "Medical Device Adverse Event Supplementary Reporting Form" (Annex 2), to the location of the provinces, autonomous regions and municipalities directly under the Central Government of the monitoring of adverse events in medical devices technical institutions. Appearance of the first report and the provisions of the preceding paragraph of the supplemental report other than the situation or medical device manufacturers to take further measures, medical device manufacturers shall promptly submit to the local provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions to submit the relevant additional information. In order to protect public safety and health, or in order to clarify the medical device adverse event report of specific issues, the province, autonomous region, municipality directly under the Central Medical Device Adverse Event Monitoring Technical Organization shall notify the medical device manufacturer in writing to submit the relevant additional information; written notice shall contain the submission of additional information on the specific requirements, reasons and time limit.
Article XVI of the second class, the third class of medical devices manufacturers should be at the end of January each year on the previous year's monitoring of adverse events of medical devices to summarize and analyze, and fill out the "annual summary report of adverse events of medical devices" (Appendix 3), reported to the location of the province, autonomous region, province-level municipalities directly under the Central Government of the monitoring of adverse events of medical devices technical institutions. Medical device business enterprises, the use of units and the first class of medical devices manufacturers should be before the end of January each year on the previous year's adverse events monitoring of medical devices to summarize, and save for inspection.
Article XVII Provinces, autonomous regions and municipalities directly under the Central Medical Device Adverse Event Monitoring Technical Institutions shall investigate, verify, analyze and evaluate the medical device adverse event reports, and report in accordance with the following provisions: (a) upon receipt of the first report of the event leading to death, it shall immediately report to the food and drug supervision and management department of the province, autonomous region and municipality directly under the Central Food and Drug Administration and the National Center for Monitoring of Adverse Drug Reactions, and at the same time (b) Upon receipt of the first report of the event leading to death, fill in the preliminary analysis on the "Suspicious Medical Device Adverse Event Report Form" within 5 working days, and report it to the food and drug supervision and management department of the province, autonomous region or municipality directly under the central government and the National Center for Adverse Drug Reaction Monitoring, and at the same time copy it to the competent department of the province, autonomous region or municipality directly under the central government; upon receipt of the supplementary report of the event leading to death and relevant additional information, report it in accordance with the following regulations After receiving the supplementary report of the event and related supplementary information, fill in the analysis and evaluation opinions on the Supplementary Report Form of Adverse Medical Device Events or form supplementary opinions within 15 working days, and report to the food and drug supervision and management department of the province, autonomous region or municipality directly under the central government and the National Center for Adverse Drug Reaction Monitoring, and at the same time copy to the competent department of health of the province, autonomous region or municipality directly under the central government; (3) Receive the first report of the event that leads to serious injury, or the event that may lead to serious injury or death. (c) After receiving the first report of the event causing serious injury or death, fill in the preliminary analytical opinion on the Medical Device Adverse Event Report Form within 15 working days, and report to the National Center for Adverse Drug Reaction Monitoring; after receiving the supplementary report of the event causing serious injury, the event that may lead to serious injury or death, and the relevant additional information, fill in the analytical opinion or form the additional opinion on the Medical Device Adverse Event Report Form within 20 working days, and report to the National Center for Adverse Drug Reaction Monitoring. (d) The received reports of events that cause or may cause serious injury or death shall be summarized and analyzed and evaluated, and reported quarterly to the food and drug administration department of the province, autonomous region or municipality directly under the central government and the National Center for Adverse Drug Reaction Monitoring, and copied to the competent department of health of the province, autonomous region or municipality directly under the central government (E) received the second, third class medical device manufacturers annual summary report, within 30 working days to put forward analysis and evaluation of opinions, reported to the National Adverse Drug Reaction Monitoring Center; at the end of February each year before the summary and put forward the analysis and evaluation of opinions, reported to the provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department.
Article 18 The National Center for Adverse Drug Reaction Monitoring shall, upon receipt of a report from the technical agency for monitoring medical device adverse events in a province, autonomous region or municipality directly under the central government, further analyze and evaluate the report, investigate and verify the report if necessary, and report in accordance with the following provisions: (1) Upon receipt of the first report of the event that resulted in a fatality, it shall be immediately reported to the State Food and Drug Administration and shall provide preliminary analytical opinions and report to the State Food and Drug Administration within 5 working days. (a) upon receipt of the first report of events leading to death, should immediately report to the State Food and Drug Administration, and within five working days to put forward a preliminary analysis, reported to the State Food and Drug Administration, while copying the Ministry of Health; receipt of supplemental reports of events leading to death and other information accordingly, within 15 working days to put forward an analysis and evaluation of the views of the State Food and Drug Administration, copying the Ministry of Health at the same time; (b) on the receipt of the events leading to, or likely to lead to, serious injuries or deaths reported, it should be summarized and (B) the receipt of reports of incidents that lead to or may lead to serious injury or death, should be summarized and put forward an analysis and evaluation of opinions, quarterly reports to the State Food and Drug Administration, and copy the Ministry of Health; (C) after receiving the annual summary report, before the end of March each year, and put forward an analysis and evaluation of opinions, to the State Food and Drug Administration, and copy the Ministry of Health.
Article XIX of the medical device adverse event monitoring technical agencies in the investigation, verification, analysis, evaluation of adverse event reports, need to organize expert demonstration or commissioned medical device testing organizations for testing, shall promptly report on the progress of work. Medical device adverse event monitoring technical body shall put forward the correlation evaluation opinion, analyze the possible reasons for the occurrence of the event.
Article 20 The medical device manufacturer, business enterprise and the use of units found sudden, group of medical device adverse events, shall immediately to the location of the province, autonomous region, municipality directly under the central government food and drug supervision and management department, the competent department of health and medical device adverse event monitoring and technical institutions to report, and fill out and submit the "Suspected Medical Device Adverse Event Reporting Form" within 24 hours. Medical device manufacturers, business enterprises and the use of units think it necessary, can be reported over the level, but should be promptly informed of the location of the transgression of the province, autonomous region, municipality directly under the central food and drug supervision and management department, the competent department of health and medical device adverse event monitoring technical institutions.
Article 21 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration was informed of the occurrence of sudden, cluster of adverse events of medical devices, shall immediately in conjunction with the competent departments of health at the same level to organize investigations, verification, treatment, and to the State Food and Drug Administration, the Ministry of Health and the National Center for Monitoring Adverse Drug Reactions report. State Food and Drug Administration in accordance with the severity of emergencies, mass incidents or emergency management work, the Ministry of Health in conjunction with the direct organization or coordination of emergencies, mass incidents of adverse events of medical devices to investigate, verify and deal with.
Article 22 of the medical device adverse event monitoring technical organizations shall report adverse events of medical devices or individual feedback information. Article 23 The medical device manufacturer shall set the medical device re-evaluation start conditions, evaluation procedures and methods according to the technical structure of medical device products, quality system and other requirements. Medical device manufacturers should analyze the adverse events of their products in a timely manner to carry out medical device re-evaluation. Medical device manufacturers through the product design retrospective study, quality system self-inspection results, product phase risk analysis and research literature on the safety risk of medical devices were informed of the existence of safety hazards of its medical devices should be carried out medical device re-evaluation.
Article 24 The medical device manufacturer in the process of re-evaluation of medical devices, should be based on the product marketed and mastered the product safety and effective information and use of experience, the original medical device registration data in the safety risk analysis report, the product technical report, the applicable product standards and instructions, clinical trial reports, labels, instructions and other technical data and content to be reevaluated.
Secondly, the medical device registration data should be reevaluated.
Article 25 The medical device manufacturer shall formulate a reevaluation program and report the reevaluation program, implementation progress and reevaluation results in accordance with the following provisions: (a) the domestic third class of medical devices and overseas medical device manufacturers, to the State Food and Drug Administration report; the domestic production of Class I and Class II medical devices, to the location of the province, autonomous region, municipality directly under the Central Government Food and drug supervision and management department report; (b) medical device manufacturers should be in the re-evaluation program before the start of implementation and the end of 30 working days after the re-evaluation program and re-evaluation of the results of the report; (c) re-evaluation of the implementation of the program period of more than 1 year, the medical device manufacturer shall report annual progress.
Article 26 of the medical device manufacturer to carry out re-evaluation of the conclusions, if necessary, should be based on the relevant provisions of the medical device registration to fulfill the registration procedures. Medical device manufacturers to re-evaluate the conclusions of the application for cancellation of the certificate of registration of medical devices, the original registration and approval department shall be completed within 30 working days after the completion of the situation reported to the State Food and Drug Administration level by level.
Article 27 The State Food and Drug Administration and the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration is responsible for supervising and inspecting the re-evaluation of medical device manufacturers, and organizing and carrying out the re-evaluation of medical devices when necessary. State Food and Drug Administration can be on the territory and overseas medical devices, provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration can be approved for listing in the administrative region of the first class, the second class of medical devices to organize and carry out re-evaluation.
Article 28 of the adverse events have occurred serious injury or death, and a threat to public safety and health of medical devices, the State Food and Drug Administration and provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration shall, in conjunction with the competent department of health at the same level, directly organize the monitoring of adverse events of medical devices and technical institutions, medical device manufacturers, user units and related technical institutions, scientific research institutions, relevant experts to carry out re-evaluation of medical devices. The State Food and Drug Administration and the food and drug administration departments of provinces, autonomous regions and municipalities directly under the central government shall, in conjunction with the competent health department, directly organize medical device manufacturers, medical device users and related technical institutions, scientific research institutions and experts to carry out re-evaluation.
Article 29 The food and drug supervision and management department to carry out the re-evaluation of medical devices, by the same level of medical device adverse event monitoring technical institutions to develop re-evaluation programs, organization and implementation, and the formation of re-evaluation report. According to the re-evaluation conclusions, the original medical device registration and approval department can order the manufacturer to modify the medical device labeling, instructions and other matters; can not guarantee the safety and effectiveness of medical devices, the original registration and approval department can make the decision to revoke the certificate of registration of medical devices. State Food and Drug Administration according to the re-evaluation of the conclusion, can make the decision to phase out medical devices.
Article 30 of the State Food and Drug Administration and the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to make the revocation of the certificate of registration of medical devices before the decision, shall inform the medical device manufacturer to enjoy the right to apply for a hearing. State Food and Drug Administration to make decisions on the elimination of medical devices before, shall be announced to the public, in accordance with the rules of the State Food and Drug Administration hearing held hearings. Article 31 In accordance with these measures to report adverse events of medical devices, medical device operators and use of units should cooperate with medical device manufacturers and competent departments to investigate the reported events, provide relevant information and take the necessary control measures.
Article 32 According to the degree of harm of the adverse events of medical devices, medical device manufacturers shall, if necessary, take warning, inspection, repair, re-labeling, revision of instructions, software upgrades, replacement, recovery, destruction and other control measures.
Article 33 In response to the occurrence of adverse events of medical devices, the control measures taken by the manufacturer may not be sufficient to effectively prevent the threat to public safety and health of medical devices, the State Food and Drug Administration can be on the territory and overseas medical devices, the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration can be on the food and drug supervision and management department in the administrative region. Approved for marketing of domestic Class I and Class II medical devices, to take measures such as issuing warnings, announcements, suspension of sales, suspension of use, and order a recall. In the event of sudden and mass occurrence of adverse events of medical devices, the food and drug supervision and management department at the provincial level or above shall take corresponding measures in conjunction with the competent health department and other competent departments at the same level.
Article 34 The State Food and Drug Administration regular or special notification of medical device adverse event monitoring and re-evaluation results, published on the medical device control measures taken. Article 35 of these measures the following terms mean: medical device adverse events, refers to the approved marketing of qualified medical devices in normal use, resulting in or may lead to human injury of all kinds of harmful events. Medical device adverse event monitoring refers to the process of detection, reporting, evaluation and control of medical device adverse events. Re-evaluation of medical devices refers to the process of re-evaluating the safety and efficacy of medical devices approved for marketing and implementing corresponding measures. Serious injury means one of the following: (a) life-threatening; (b) resulting in permanent injury to the function of the organism or permanent damage to the structure of the organism; (c) medical measures must be taken to avoid the above permanent injury or damage. Medical and health institutions, in accordance with the provisions of the "Regulations on the Administration of Medical Institutions", medical institutions and other health institutions subordinate to the competent health authorities to obtain the "license to practice in medical institutions".
Article 36 The medical device manufacturers whose products are listed and sold both in China and abroad shall report to the National Center for Adverse Drug Reaction Monitoring and the State Food and Drug Administration within 15 days from the date of discovery of the adverse events of medical devices occurring outside China of their relevant products that cause or may cause serious injury or death, as well as the control measures taken.
Article 37 of the clinical trial of medical devices occurring in accordance with the provisions of the clinical trials of medical devices or may lead to human injury of various harmful events shall be reported in accordance with the "Regulations on Medical Devices" and the State Food and Drug Administration's relevant requirements.
Article 38 The corresponding provisions of these measures on medical device manufacturers, applicable to overseas medical device manufacturers in China's agents. Including overseas medical device manufacturers in China's representative organizations or designated corporate units in China. Taiwan, Hong Kong and Macao medical device manufacturers refer to overseas medical device manufacturers.
Article 39 The content and statistics of medical device adverse event report is to strengthen the supervision and management of medical devices, guidance to carry out the re-evaluation of medical devices based on, not as a medical dispute, medical litigation and the handling of medical device quality accidents. For medical accidents or medical device quality problems, should be dealt with separately in accordance with the requirements of relevant regulations.
Article 40 of the food and drug supervision and management departments and their relevant staff in the monitoring and management of medical device adverse events in violation of regulations, delays in adverse event reporting, failure to take effective measures to control the recurrence of serious medical device adverse events and cause serious consequences, in accordance with relevant provisions of the administrative sanctions.
Article 41 of the medical device adverse event report of the relevant forms and corresponding computer software compiled by the State Food and Drug Administration.
Article 42 The State Food and Drug Administration in conjunction with the Ministry of Health is responsible for the interpretation of these measures.
Article 43 These measures shall come into force on the date of publication.