Chapter 1 General Principles

Article 1 In order to strengthen the monitoring and re -evaluation of adverse events of medical equipment，Timely、Effective control of medical device risks after listing，Guarantee human health and life safety，According to the "Regulations on the Supervision and Administration of Medical Device"，Formation of this method。

Article 2 Monitor the adverse event of medical device in the People's Republic of China、Review and its supervision and management，Applicable these Measures。

Article 3 The holder of the medical device listing permit (hereinafter referred to as the holder)，The quality management capacity and corresponding responsibility ability to ensure the safety and effectiveness of medical equipment，Establish a medical device adverse event monitoring system，Monitoring technology institutions (hereinafter referred to as monitoring agencies) directly reported to medical device adverse events。Business companies authorized by the holder、Medical equipment use units shall report to the holder and monitoring agency for bad events in medical device。
The holder should evaluate the adverse events discovered，Perfect the product quality according to the evaluation results，Measures to evaluate the results and improve quality measures to the monitoring agency; requiring the approval of the original registered authority，The application shall be submitted in accordance with regulations。
The agent designated by overseas holders shall bear the monitoring of adverse events of imported medical devices sold in China，Cooperate with overseas holders to fulfill their re -evaluation obligations。

Article 4 The meaning of the following words in these Measures:
(1) The holder of the medical device listing permit，refers to the holder of the medical device registration certificate and medical device filing certificate，That is medical device registrar and recorder。
(2) Adverse events of medical equipment，refers to the medical equipment that has been listed，What happened under normal use，Various harmful events caused by or may cause human damage。
(3) Severe damage，refers to one of the following situations:
1. Live -end life;
2. Permanent damage to the function of the body or permanent damage of the body structure;
3. Medical measures must be taken to avoid the above permanent damage or damage。
(4) Bad events of group medical equipment，refers to the same medical device during use，At the relatively concentrated time、occurred in the area，Incidents that cause damage or threats caused by the health or life safety of a certain number of people。
(5) Monitoring of bad events of medical equipment，refers to the collection of bad events of medical equipment、Report、Investigation、Analysis、Evaluation and control process。
(6) Key monitoring of medical equipment，refers to the risk of studying a variety or after the product is listed、Features、Severe level、incidence rate, etc.，Pharmaceutical monitoring activities that actively carried out。
(7) Re -evaluation of medical devices，refers to the registered or filing、Safety of medical devices sold on the market、Re -evaluation of effectiveness，The process of taking corresponding measures。

5 The State Drug Administration establishes the monitoring information system of the National Medical Device Never Equipment，Strengthening the Monitoring Information Network and Database Construction。
Monitoring agencies (hereinafter referred to as national monitoring agencies) designated by the State Drug Administration (hereinafter referred to，and to relevant monitoring agencies、holder、Management enterprise or use unit feedback medical device adverse event monitoring related information。
Monitoring information related to product use risk shall be notified to the health administrative department。

Article 6 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall establish a medical device adverse event monitoring system，Improve the relevant system，Equipped with corresponding monitoring agencies and personnel，Monitoring of bad events of medical equipment。

7 Any unit or individual discovered bad events for medical devices，It has the right to report to the department responsible for drug supervision and management (hereinafter referred to as the drug supervision and management department) or the monitoring agency。

Chapter 2 Responsibilities and Obligations

Article 8 The State Drug Administration is responsible for the supervision and management of the monitoring and re -evaluation of adverse events of medical devices in the country，In addition to the Health Administrative Department of the State Council, it organizes a large -scale impact and serious damage or death, and other serious consequences.，Urgent control measures in accordance with the law。

Article 9 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government is responsible for the monitoring and re -evaluation supervision and management of bad events in the administrative area，In addition to the health administrative departments of the same level and relevant departments, organize the investigation and processing of adverse incidents in group medical devices in the administrative area，Urgent control measures in accordance with the law。
The city -level and county -level drug supervision and management departments of the district are responsible for the monitoring of adverse events in the administrative region。

Article 10 Supervision and Administrative Department of Drug Supervision and Administration of the Supervision and Administration of the Super Leading Drug Supervision and Administration of the Supervision and Administration of Medical Device Monitoring and Repequet。

Article 11 The health administrative department of the State Council and local health administrative departments at all levels are responsible for supervision and management related to the monitoring of adverse events in medical device use，Understand the supervision of medical device use units to monitor related work and organize inspections，Evaluation of the monitoring of adverse events of medical equipment，A relevant control measures are taken to adverse medical equipment in accordance with the law within the scope of responsibility。
The guidance and supervision of the higher -level health administrative department to supervise the lower -level health administrative department to carry out the supervision and management of adverse incidents of medical device。

Article 12 State monitoring agencies are responsible for receiving holders、Information about bad events reported in the reporting enterprise and use units, etc.，Relevant technical work on the monitoring and re -evaluation of non -performing incidents in medical device in the country; responsible for the construction of information networks and databases for the monitoring information network and database of bad events in the country、Maintenance and information management，Organization to formulate technical specifications and guidance principles，Organize the survey of the relevant information of bad events approved by the State Drug Administration of Drug Administration、Evaluation and feedback，Summarize the information of bad events approved by the local drug supervision and management department at or above the municipal level or above、Analysis and guidance，Development of large -scale impacts and severe damage or death, and other serious consequences to investigate and evaluate bad events。

Article 13 province、Autonomous Region、Monitoring agencies (hereinafter referred to as provincial monitoring agencies) designated by the drug supervision and management department of the municipality directly under the Central Government to carry out the monitoring and re -evaluation of related technical work in bad events in the administrative region; undertake relevant technical work in the registered or filed medical device registered or filed in the administrative area Investigation of the event、Evaluation and feedback，Investigate and evaluate the adverse incidents of group medical devices in this administrative area。
The city -level and county -level monitoring agencies of the district assisted in carrying out the relevant technical work of adverse events in the administrative region。

Article 14 The holder shall continue to study the medical devices it goes on sale，Evaluation risk，Responsibility for the monitoring of adverse events of medical equipment，Effective control measures are taken according to the results of the analysis and evaluation，Perform the following main obligations:
(1) Establish a medical device quality management system that includes the monitoring and re -evaluation of the bad events of medical device;
(2) Equipped with institutions and personnel who are compatible with their products engaged in the monitoring of adverse events of medical equipment;
(3) Actively collect and in accordance with the time limit requirements stipulated in these Measures to report to the monitoring agency truthfully in a timely manner;
(4) Investigation on bad events that occurred in the medical device that occurred、Analysis、Evaluation，Take measures to control risks，Release risk information in time;
(5) Continuous research on the safety of listed medical equipment，Write regular risk evaluation reports as required;
(6) Actively carry out medical device re -evaluation;
(7) Investigation by adverse events organized by the drug supervision and management department and the monitoring agency。

Article 15 Overseas holders except the obligations stipulated in Article 14 of these Measures，It should also establish an information transmission mechanism with the designated agent，Timely interoperability Monitoring and re -evaluation Stake Sports Bettingof relevant information。

Article 16 Medical Device Business Enterprise、Use unit shall fulfill the following main obligations:
(1) Establish a system of monitoring work system for adverse events in the unit of medical equipment，Medical institutions shall also include the monitoring of adverse events of medical equipment into the key work of quality and safety management of medical institutions;
(2) Equipped with institutions or personnel that are compatible with its operation or use of scale to engage in the monitoring of adverse events of medical device;
(3) Collect bad events of medical equipment，Report to the holder in time，and report to the monitoring agency as required;
(4) Investigation of the holder's bad incident on medical equipment、Evaluation and medical device re -evaluation work;
(5) Investigation of adverse events organized by the drug supervision and management department and monitoring agency。

Chapter 3 Report and Evaluation

The basic requirements of Section 1

Article 17 Reporting adverse incidents of medical equipment shall follow the principle of suspicious reports，When a certain incident is a bad incident of medical equipment，All can be reported as a bad event for medical devices。
The content of the report should be true, complete, and accurate.

Article 18 of the suspicious medical equipment that may cause severe damage or death shall be reported;，It should be reported to all bad events of the product of the product。

Article 19 holders、Medical institutions of operating enterprises and levels above levels shall register as users of the monitoring information system of non -performing events in the national medical device，Actively maintaining its user information，Report a bad event for medical equipment。The holder shall continue to track and process monitoring information; the product registration information changes，It should be updated immediately in the system。
Encourage other users to register as a user of the monitoring information system for national medical device adverse events，Report the relevant information of bad events。

Article 20 The holder shall announce the phone call、Mailing address、Email、Fax contact information，Designated contact，Active collection of medical device business enterprises、Use unit、User and other bad events;，The holder shall perform the report and evaluation of bad events of medical equipment through the monitoring information system of the National Medical Device Adverse Equipment Monitoring Information System，Report the survey report of bad events of the group medical device and regular risk evaluation report。
Medical Device Business Enterprise、Use the unit to discover or know the bad incident of suspicious medical equipment，shall be inform the holder in time，Report through the monitoring information system of adverse events of medical device。No online reporting conditions，It should be reported to the monitoring agencies at the prefecture level at the prefecture level through the paper.，On behalf of the monitoring agency online report。
Monitoring agencies at all levels shall announce calls、Mailing address and other contact information。

Article 21 The holder shall analyze the monitoring information of adverse events collected and known for collection and knows、Evaluation，Active research on medical device safety research。Medical equipment approved for conditional approval，The holder should also carry out related work in accordance with the risk management and control plan。

Article 22 holder、Business Enterprise、Use unit shall establish and preserve the monitoring records of adverse events of medical equipment。Use unit shall establish and preserve the monitoring records of adverse events of medical equipment，The storage period must not be less than 5 years。Monitoring records of implanted medical devices should be permanently stored，Medical institutions shall be kept in accordance with the relevant provisions of cases。

Article 13 Provincial monitoring agencies shall conduct a comprehensive analysis of adverse events of medical devices registered or filed in the administrative area，Make supervision measures for the risk found，Report the location of the location within 30 days after the end of each quarter、Autonomous Region、Drug supervision and management department and national monitoring agency。
National monitoring agencies shall report bad events and provinces for medical devices approved by the State Drug Administration、Autonomous Region、The quarterly report of the drug supervision and management department of the municipality directly under the Central Government conducts comprehensive analysis，If necessary, propose supervision measures to the State Drug Administration。

Article 24 Provincial monitoring agencies shall summarize and analyze the monitoring of bad events registered or filed in the administrative area in accordance with the year，Form an annual summary report，Report to the local province in the place before March 15 every year、Autonomous Region、Drug supervision and management department and national monitoring agency。
National monitoring agencies shall summarize and analyze the annual monitoring of adverse events in the country in the country，Form an annual report，Report to the State Drug Administration。
Drug supervision and management departments above the provincial level shall notify the annual reporting situation at the same level of the health administrative department at the same level。

Section 2 Personal Case Medical Device Adverse Event

Article 25 of the holder discovered or learned about the bad incident of suspicious medical equipment，It should be investigated immediately，If death, it should be reported within 7 days; causing serious damage、If it may lead to severe damage or death, it shall be reported within 20 days。
Medical Device Business Enterprise、Use the unit to discover or know the bad incident of suspicious medical equipment，shall be inform the holder in time。Where，Caused by death shall be within 7 days，Cause serious damage、It may cause severe damage or death within 20 days，Monitoring Information System Report through the National Medical Device Adverse Equipment。

Article 26 Except holder、Business Enterprise、Units and individuals other than the use of the unit discovery or the adverse incidents of medical devices that may cause severe damage or death，You can report to the monitoring agency，You can also get to the holder、Report of operating enterprises or medical institutions for management，Provide relevant medical record information when necessary。

Article 27 Overseas holders of imported medical devices and holders who sell domestic medical devices abroad，It should take the initiative to collect the bad events of medical device that occurred abroad。Where，Cause or may cause severe damage or death，The agent and domestic medical device holder designated by the overseas holders should be reported for spontaneously or about 30 days from the date of knowledge。

Article 28 The municipal monitoring agencies of the district shall be within 10 days from the date of receiving the report of the bad incident of medical device，The authenticity of the report、Out of integrity and accuracy，Real -time feedback related holders。

Article 29 The holder learned about the relevant medical device adverse events after reporting the bad incident of medical equipment or through the national medical device adverse event monitoring information system，Follow -up surveys should be carried out as required、Analysis and evaluation，The incident that caused death should be within 30 days，Cause serious damage、Incidents that may cause severe damage or death shall report the evaluation results to the provincial monitoring agency where the holder is located within 45 days。There are new discovery or cognition for the incident and evaluation results，It should be supplemented for report。

Article 30 Provincial monitoring agencies where the holder is located shall complete the review of the evaluation results within 10 days when receiving the evaluation results of the holder，If necessary, you can commission or will conduct on -site investigations on the spot in the provincial monitoring agencies that cause or may cause severe damage or death.。Where，For medical devices approved by the State Drug Administration，National monitoring agencies should also review the evaluation results made by provincial monitoring institutions，If necessary。
The results of the review and review shall be fed back to the holder。There is an objection to the evaluation results of the holder，You can ask the holder to re -evaluate。

Section III group medical equipment bad events

Article 31 holder、Business Enterprise、After the unit discovered or learned the adverse incident of the group medical equipment，It should be reported to the province of the place where adverse events occurred by phone or fax within 12 hours、Autonomous Region、The drug supervision and management department and the health administrative department of municipality directly under the Central Government，If necessary, you can go over and report，At the same time, the basic information of adverse events of medical devices in group medical devices is reported through national medical device adverse events.，For each event, it should be reported in a case of examples in 24 hours。
Prefecture provinces、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall promptly provide the province where the holder is located、Autonomous Region、The drug supervision and management department of the municipality notified the relevant information。

Article 32 After the holder discovered or learned the group medical equipment of the product, the group medical device adverse incident，It should be suspended immediately、Sales，Notify the use unit to stop using related medical equipment，Self -checking of survey and production quality management system at the same time，and province to the location of the location and the bad incident within 7 days、Autonomous Region、Report on the drug supervision and management department and monitoring agency of the municipality directly under the Central Government。
Investigation should include product quality status、The correlation between damage and product、Use link operation and circulation process compliance, etc.。Self -check should include purchasing、Production Management、Quality Control、Tracking of the same model of the same model。
The holder should analyze the cause of the incident，Release risk information in time，The location of the self -inspection and the control measures taken by the control measures and the province of bad events、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government，Related medical equipment should be recalled if necessary。

Article 33 of the medical device business enterprise、Use the unit to discover or know the bad events of the group medical equipment，It should be informed of the holder within 12 stake online sports bettinghours，Quick self -check stake betting appat the same time，and cooperate with the holder to conduct a survey。Self -check should include product storage、Trace of circulation process，Tracking of the same model of the same model, etc.; self -examination of the use unit should also include whether the use process meets the operating specifications and product description requirements。When necessary，Medical Device Business Enterprise、Use unit shall suspend the sales of medical equipment、Use，Assist relevant units to take relevant control measures。

Article 34 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government has learned that the poor incidents of group medical equipment in this administrative area，It should be conducted on -site surveys in a timely manner with the health administrative department of the same level，Related provinces、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall cooperate with。Investigation、Evaluation and processing results shall be reported to the State Drug Administration and the health administrative department of the State Council，Copy to the location of the holder、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。

Article 35 of the group medical device adverse events that have a greater impact on the country and cause severe damage or death, and other serious consequences，The State Drug Administration shall organize investigations and treatment with the health administrative department of the State Council。National monitoring agencies are responsible for on -site investigation，Related provinces、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government、The health administrative department shall cooperate。
The survey content should include the occurrence of adverse events of medical equipment、Use of medical equipment、Patient diagnosis and treatment、Similar to bad events、Product production process、Product storage and circulation, and the same type of product tracking of the same model。

Article 36 State monitoring agencies and related provinces、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government、The health administrative department shall be within 5 days after the investigation is over，Make technical evaluation of product risks and propose control measures for product risk based on the survey.，Forms an investigation report to report to the State Drug Administration and the health administrative department of the State Council。

Article 37 The province where the holder is located、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government can conduct on -site inspections on the holders involved in the group's bad events。When necessary，The State Drug Administration can conduct on -site inspections on overseas holders involved in bad events.。
On -site inspection should include the operation of the production quality management system、Product quality status、Production process、Tracking of the same model of the same model。

Section 4 Term Risk Evaluation Report

Article 38 The holder shall continue to study the safety of listed medical equipment，Report on bad events of the product、Monitoring information and domestic and foreign risk information summarize、Analysis，Evaluate the risk and benefit of the product，Recorded risk control measures，Write regular risk evaluation report after listing。

Article 39 The holder shall be from the date of the first approved registration or filing of the product，Complete the regular risk evaluation report after the last year's product listing is completed within 60 days after a year。Where，registered by the State Drug Administration，It shall be submitted to the state monitoring agency;、Autonomous Region、Registered by the drug supervision and management department of the municipality directly under the Central Government，It should be submitted to the provincial monitoring agency where the location is located。The regular risk evaluation report of the first category of medical devices is reserved by the holder for preparation。
Get medical equipment that continues registered，The regular risk evaluation report of this registration cycle should be completed when the registration application is continued for the next time，And the holder retains for investigation。

Article 40 Monitoring agencies at or above the provincial level shall organize the regular risk evaluation report of the receiving medical device products after listing。When necessary，Feedback of the review opinion holder should be feeded。

Article 41 Provincial monitoring agencies shall comprehensively analyze the regular risk evaluation report of the after -listed periodical after listing，The statistical and analysis and evaluation results will、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。
State monitoring agencies shall comprehensively analyze the statistical statistics and analysis and evaluation results submitted by the provincial monitoring agencies after the listing of regular risk evaluations and provincial monitoring agencies，The statistics and analysis and evaluation results will be reported to the State Drug Administration。

Chapter 4 Key Monitor

Article 42 The drug supervision and management department of the provincial level may organize the key monitoring of medical equipment，Research after the listing of strengthening medical device products。

Article 43 The State Drug Administration, together with the State Council's health administrative department, determine the key monitoring varieties of medical device，Organization to formulate a key monitoring work plan，and supervise the implementation。
National medical device key monitoring varieties shall register according to medical equipment、Monitoring of bad events、Supervision and inspection、Inspection, etc.，Confirmation of the degree of product risk and usage。
National Monitoring Institutions Organize the implementation of key medical device monitoring work，and complete the relevant technical report。The drug supervision and management department can take necessary management measures based on the risks found in the monitor。

Article 44 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government can according to the needs of medical device supervision in this administrative area，Refer to Article 43 of these Measures，For the second category of registered in the administrative division and the first type of medical device registered in the administrative region, carry out key provincial medical device key monitoring work。

Article 45 The holders involved in the key monitoring varieties of medical device shall be carried out in accordance with the requirements of the key monitoring work plan of the medical device，Actively collects related risk information such as bad events of its products，Writing risk evaluation report，and submit it to the key monitoring work organization。

Article 46 The drug supervision and management department of the provincial level may specify units with certain conditions as monitoring whistle，Actively collect key monitoring data。Monitoring whistle should provide the use of key monitoring varieties of medical device，Active collection、Report bad events monitoring information，Organization or recommended relevant experts to carry out or cooperate with the monitoring institution to carry out scientific research work related to risk evaluation。

Article 47 Innovative medical device holders shall strengthen the active monitoring of innovative medical equipment，Develop a product monitoring plan，Actively collect relevant bad events reports and product complaint information，Cut a survey、Analysis、Evaluation。
Innovative medical device holders shall be within the first registration cycle，Summary report on the monitoring analysis and evaluation of product adverse events to the state monitoring agency every six months。National monitoring agencies found that there may be serious defects in medical devices，It should be reported to the State Drug Administration in time。

Chapter 5 Risk Control

Article 48 Monitoring through adverse events of medical equipment，It is found that there is a medical device that may endanger human health and life safety.，The following risk control measures should be taken according to the situation，Report the province where the location is located、Autonomous Region、Drug Supervision and Management Department of Municipal Government:
(1) Stop production and sales related products;
(2) Notification of medical device business enterprises、Use unit to suspend sales and use;
(3) Implement product recall;
(4) Release risk information;
(5) Self -examination of the production quality management system，and rectify related issues;
(6) Modify instructions, labels, operating manuals, etc.;
(7) Improve production technology、Design、Product technical requirements, etc.;
(8) Re -evaluation of medical equipment for medical devices;
(9) Change registration or filing according to regulations;
(10) Other risk control measures that need to be taken.
Risks and disposal status related to the safety of weapon，The holder shall announce it to the society in a timely manner。

Article 49 Drug Supervision and Administration Department believes that the control measures taken by the holder are not enough to effectively prevent risks，You can take the issuing warning information、Suspension of production and sales and use、Order recall、Requires it to modify the instructions and labels、Organization and other measures such as re -evaluation，Organize supervision and inspection of the holder。

50. Medical equipment for adverse incidents of group medical equipment，Drug supervision and management departments above the provincial level can be based on risks，Adopt pause production、Sales、Use control measures and other control measures，Organizational supervision and inspection of the holder，and timely issue warning and disposal information to the society。After the technical evaluation conclusion is obtained，Drug supervision and management departments above the provincial level shall shall be in accordance with the requirements of relevant regulations，Take further regulatory measures，and strengthen the monitoring of bad events of similar medical devices。
The health administrative department of the same level shall suspend the use of related medical equipment in the administrative area，Take measures to actively organize the treatment of patients。Related holders should cooperate。

Article 51 The evaluation and review of monitoring agencies at or above the provincial level at the bad incident of medical device、Bad Event Reporting Jourary and Annual Summary Analysis、Evaluation of bad events in the group、Key monitoring、Regular risk evaluation reports and other processes，It is found that there is an unreasonable risk of medical equipment，Risk management opinions should be made，Timely feedback the holder and report the corresponding drug supervision and management department。Provincial monitoring agencies should also report to the state monitoring agency。
The holder shall formulate and implement the corresponding risk control measures based on the risk management opinions received。

Article 52 Drug supervision and management departments at all levels and health administrative departments may entrust the products involved in the product involved in bad medical devices to check the product inspection institutions stake online sports bettingstake sports betting appwith corresponding qualifications。The medical device inspection agency shall carry out relevant inspection in a timely manner，and issue a inspection report。

Article 53 Imported medical device adverse events occurred abroad，or domestic medical devices occurred abroad abroad，The control measures are taken，The agent or domestic medical device holder designated by the overseas holder shall be within 24 hours after learning，Bad events of overseas medical equipment、Control measures and control measures to be taken in the country are reported to the State Drug Administration and State Monitoring Institution，Copy in the province where the location is located、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government，Report the follow -up disposal in time。

Article 54 Caused by the quality reasons for the quality of medical device products，It is dealt with by the drug supervision and management department in accordance with the relevant regulations of medical equipment;，Disposal by the health administrative department。

Chapter 6 Review

Article 55 There is one of the following situations，The holder should take the initiative to carry out re -evaluation，and evaluate the conclusion based on re -evaluation，Take corresponding measures:
(1) According to the development of scientific research，Safety of medical equipment、Effective changes in understanding;
(2) Monitoring of bad events of medical device、Assessment results indicate that there may be defects in medical devices;
(3) State Drug Administration stipulates that other situations that should be re -evaluated。

Article 56 The holder is evaluated for medical devices，The product safety and effective information should be learned and mastered according to the product after listing、Clinical data and experience，Summary information in the registered information of the original medical device、Research Information、Clinical evaluation information、Product risk analysis information、Product technical requirements、Manual、Tags and other technical data and content for re -evaluation。

Article 57 The re -evaluation report shall include product risk benefit evaluation、Social and economic benefits evaluation、Technical Progress Evaluation、Measures and suggestions intended to take。

Article 58 The holder actively carried out the re -evaluation of medical equipment，It should formulate a re -evaluation work plan。Through the re -evaluation, it is determined that the control measures need to be taken，It should be within 15 days after the re -evaluation conclusion，Submit the re -evaluation report。Where，Medical Device approved by the State Drug Administration for registration or filing，The holder shall be submitted to the state monitoring institution; the holders of other medical equipment shall submit to the provincial monitoring agency where they are located。
The holder fails to perform the obligations of the medical device's re -evaluation obligations in accordance with the regulations，Drug supervision and management departments above the provincial level shall order the holder to carry out re -evaluation。When necessary，Drug supervision and management departments above the provincial level can directly organize and re -evaluate。

Article 59 The drug supervision and administration department at or above the provincial level is ordered to conduct re -evaluation，The holder shall submit the re -evaluation plan and the re -evaluation report to the corresponding drug supervision and management department and the monitoring agency within 30 days before the re -evaluation implementation。
The period of evaluation of the implementation period exceeds 1 year，The holder should report the annual progress of the year。

Article 60 Monitoring agencies review the re -evaluation report received by the receiving holders，and report the audit opinion to the corresponding drug supervision and management department。
The drug supervision and management department has objections to the re -evaluation conclusion of the holder，The holder shall reintermine the re -evaluation results in accordance with the requirements of the drug supervision and management department or re -evaluate the re -evaluation。

Article 61 The Drug Supervision and Administration Department organizes the re -evaluation of medical devices，Formulate a re -evaluation plan by the specified monitoring agency，Organization and implementation of the pharmaceutical supervision and management department of the organization and re -evaluated evaluation，Report to the corresponding drug supervision and management department after forming a re -evaluation report。

Article 62 The re -evaluation results indicate that there are defects that are registered or filed with medical devices that have endangered personal safety，and cannot be improved through technical improvement、Modification instructions and labels to eliminate or control risks，or the risk benefit ratio is unacceptable，The holder shall take the initiative to apply for cancellation of the medical device registration certificate or cancel the product filing;，Cancelin the medical device registration certificate or cancel the filing of the original certificate department。The drug supervision and management department shall promptly publish the cancellation of the medical device registration certificate or cancel the relevant information of the filing。
The State Drug Administration is based on the re -evaluation conclusion，Decisions for eliminating medical device varieties。The eliminated product，Its medical device registration certificate or product filing shall be canceled or canceled by the original certificate department。
Registration of medical device registration certificates or canceled medical devices shall not be produced、Import、Operation and use。

Chapter 7 Supervision and Management

Article 63 The drug supervision and administration department shall supervise and check the supervision and re -evaluation of the holders of the holder and the business enterprise in accordance with their duties.，In addition to the health administrative department of the same level, the monitoring and inspection of medical device use units is conducted in the medical device use unit。

Article 64 province、Autonomous Region、The drug supervision and management department of the municipality directly under the Central Government shall formulate the supervision and inspection plan of the adverse event of medical device in the administrative area，Determine the key check focus，and supervise the implementation。

Article 65 province、Autonomous Region、The drug supervision and management department of municipality directly under the Central Government shall strengthen the training and assessment of the monitoring and re -evaluation of non -performing incidents in the administrative region。

Article 66 The drug supervision and management department shall be in accordance with regulations、Regulations、Regulations for specifications，Supervision and inspection of the construction and work development of the holder's adverse event monitoring system。When necessary，Extension inspections can be carried out on enterprises entrusted by the holder to carry out related work。

Article 67 There is one of the following situations，The drug supervision and management department shall carry out key inspections on the holder:
(1) If it is not proactively collected and reported according to the time limit, it is reported to report bad events in medical equipment;
(2) The number of reports that may cause severe damage or adverse deaths from the number of reports from the number of reports of the number of reports may be reported by the holder，It is prompted that the main responsibility is not implemented;
(3) Hidden, missed reports, and false reports;
(4) The relevant investigations and control measures that do not cooperate with the drug supervision and management department;
(5) The safety information of product safety information is not monitored by adverse events in accordance with the requirements，or did not conduct research after listing as required、Review，It cannot guarantee the safety and effective product。

Article 68 The holder fails to establish a bad event monitoring system、Carry out bad events monitoring and re -evaluate related work、Not adopted effective risk control measures in time in accordance with Article 48 of these Measures、The relevant investigation and control measures taken by non -combined medical device in the drug supervision and management department，Drug Supervision and Management Department can require it to suspend production and rectification，Control measures to stop product sales if necessary。
You need to restore production、Sales，The holder shall apply to the drug supervision and management department of the processing decision，Drug Supervision and Administration Department on -site inspections and passed through，Make recovery production、Decision of sales。
The holder proposes to restore production、Before the sales application，You can hire an independent third -party professional organization with corresponding qualifications for inspection and confirmation。

Article 69 The Drug Supervision and Administration Department of the Provincial level uniformly released the monitoring information of the following adverse events of medical device:
(1) Information related to bad events in group medical devices;
(2) Monitoring information of adverse events of medical equipment;
(3) Monitoring information of adverse event adverse events that need to be released regularly;
(4) The monitoring information of other medical device adverse events that is required to be released uniformly。

Chapter 8 Legal Responsibility

Article 70 The holder has one of the following circumstances，In accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Device，The drug supervision and management department at or above the county level is ordered to make corrections，Give warning;，Fined fines of 5,000 yuan to less than 20,000 yuan; if the circumstances are serious,，Order to stop production and stop business，until the relevant certification documents were revoked by the issuing department:
(1) If it is not proactively collected and reported according to the time limit, it is reported to report bad events in medical equipment;
(2) Concerning, missed reports, and false reports;
(3) If the evaluation results of the reported evaluation results in accordance with the time limit are required or submitted a survey report for the adverse event of the group medical device;
(IV) Do not cooperate with the drug supervision and management department and the monitoring institution's medical device adverse events related to investigation and control measures taken。

Article 71 Medical Devices Business Enterprise、The use unit has one of the following situations，In accordance with Article 68 of the Regulations on the Supervision and Administration of Medical Device，from the drug supervision and management department of the county level and the health administrative department to order correction in accordance with their respective responsibilities，Give warning;，Fined fines of 5,000 yuan to less than 20,000 yuan; if the circumstances are serious,，Order to stop production and stop business，until the relevant certification documents were revoked by the issuing department:
(1) If it is not proactively collected and reported according to the time limit, it is reported to report bad events in medical equipment;
(2) Concerning, missed reports, and false reports;
(3) Do not cooperate with the medical device adverse events carried out by the drug supervision and management department and the monitoring agency.。

Article 72 The holder fails to conduct a re -evaluation in accordance with the requirements、Hidden re -evaluation results、It should be submitted to the application for stake sports betting appstake sports betting appcancellation and not submitted，The drug supervision and management department of the provincial level ordered to make corrections，Give warning，It can be fined together for 10,000 yuan and 30,000 yuan。

Article 73 The holder has one of the following circumstances，The drug supervision and management department at or above the county level is ordered to make corrections，Give warning;，Fined fines of 5,000 yuan or less than 20,000 yuan:
(1) Those who have not established a medical device adverse event monitoring and re -evaluation working system in accordance with regulations;
(2) Institutions and personnel who have not been equipped with their products in accordance with their products are not equipped with the monitoring of bad events in medical device;
(3) Insufficient monitoring records or inadequate preservation periods of non -preserved adverse events;
(4) It should be registered without registering as a user of the monitoring information system for medical device adverse events;
(5) Unsurable user information，or not continuously tracking and processing monitoring information;
(6) If corresponding control measures are not taken according to adverse events and announced to the society;
(7) Not writing as required、Submit or retain the regular risk evaluation report after listing;
(8) Failure to report abnormal incidents and overseas control measures in overseas medical device as required;
(9) If the analysis and evaluation report of innovative medical device products is not submitted in accordance with the requirements;
(Ten) No contact information、Actively collect bad events information;
(11) If the key monitoring of medical equipment is not carried out in accordance with the requirements;
(12) Other violations of these Measures.

Article 74 Medical Devices Business Enterprise、The use unit has one of the following situations，from the drug supervision and management department of the county level and the health administrative department to order correction in accordance with their respective responsibilities，Give warning;，Fined fines of 5,000 yuan or less than 20,000 yuan:
(1) Those who have not established a medical device adverse event monitoring work system as required;
(2) The institutions or personnel who are not equipped with or using the scale are not equipped with the monitoring of bad incidents of medical device;
(3) Insufficient monitoring records or inadequate preservation periods of non -preserved adverse events;
(4) It should be registered without registering as a user of the monitoring information system of non -performing events in the national medical device;
(5) If you fail to report or know the bad events collected or learned to the holder in time;
(6) It is not cooperated with the holder to investigate and evaluate the adverse incidents of medical equipment;
(7) Other violations of these Measures.
The drug supervision and management department found that the use unit has the prescribed behavior of the previous paragraph，It should be transferred to the same level of the health administrative department of the same level for treatment。
The health administrative department makes an administrative penalty decision on the use unit，shall promptly notify the drug supervision and management department of the same level。

Article 75 holder、Business Enterprise、Use unit to report in accordance with the requirements of these Measures、Investigation、Evaluation、Disposal of bad events of medical equipment，Actively eliminate or reduce the consequences of harm，Related illegal acts，According to the provisions of the "Administrative Penalty Law of the People's Republic of China"。illegal acts are slightly and corrected in time，No harmful consequences，No punishment，But it is not available to other legal liabilities that should be assumed in accordance with the law。

Article 76 The drug supervision and management department at all levels、Health Administrative Department、Monitoring agencies and their staff，If you do not perform your duties in accordance with regulations，It is handled in accordance with the provisions of Article 72 and 74 of the Regulations on the Supervision and Administration of Medical Devices。

Article 77 holder、Business Enterprise、Use unit violations of relevant regulations，What causes damage to the user of medical equipment，Bersed compensation responsibility in accordance with the law。

Chapter 9 Attachment

Article 78 The content of the report on bad events of medical equipment、Risk Analysis Evaluation Report and Statistical Data are strengthening medical device supervision and management、Guidance of the basis of reasonable use of weapons，Not a medical dispute、The basis for the quality of medical device quality accidents for medical lawsuits。
For the quality of the quality of the medical accident or medical device，It should be handled separately in accordance with the requirements of the relevant regulations。

Article 79 This Measures shall be explained by the State Drug Administration in conjunction with the State Council's Health Administrative Department。

Article 80 These Measures will be implemented from January 1, 2019。