Quote from VigiServe Admin on January 3, 2021, 7:55 AM

ONLINE DEVICE REACTION REPORTING

"Administrative Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices" (Order No. 1 of the State Administration for Market Regulation)
Release Date: 2018-12-10
The "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices" have been reviewed and approved by the State Administration for Market Regulation and the National Health Commission, and are hereby promulgated and will be implemented as of 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 Provisions

 

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 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 product quality 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 as required.

The agent designated by the overseas holder shall undertake the monitoring of adverse events of imported medical devices sold in China, and cooperate with the overseas holder to perform the obligation of re-evaluation.

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) Medical device adverse events refer to various harmful events that cause or may cause harm to the human body that occur under normal use of medical devices that have been marketed.

(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 collecting, reporting, investigating, analyzing, evaluating and controlling 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 agencies 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 administration (hereinafter referred to as the drug supervision and administration 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 city-level and county-level drug supervision and administration departments divided into districts are responsible for the monitoring of medical device adverse events in their 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 supervision and management 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 situation, 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 including 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 user units shall perform the following main obligations:

(1) Establish a monitoring system for medical device adverse events of the unit, and medical institutions should also include the monitoring of medical device adverse events in 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 to engage in medical device adverse event monitoring related work;

(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 when 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 related to 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.

Medical device operating companies and user units that discover or learn of suspicious medical device adverse events shall promptly notify the holders and report them through the National Medical Device Adverse Events 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 The provincial monitoring agency shall conduct a comprehensive analysis of the adverse event reports of medical devices registered or filed in the administrative area, and propose regulatory measures for the risks discovered, and report to the province, autonomous region, or local province 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 conduct a summary analysis of the annual monitoring of adverse events of medical devices across the country, and form an annual report, which shall be submitted to the State Drug Administration before 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, possibly causing serious injury or death within 20 days, through the National Medical Device Adverse Event Monitoring Information System.

Article 26 If any unit or individual other than the holder, operating enterprise, or user unit discovers an adverse event of a medical device that causes or is likely to cause serious injury or death, it 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, events that cause serious injury, may cause serious injury or death should be reported to the provincial monitoring agency where the holder is located within 45 days.