Job Responsibilities 1.1 Take responsibilities for medical device adverse events surveillance. 1.2 Establish the medical device adverse events surveillance system. 1.3 Collect, investigate, analyze, evaluate, report, and control medical device adverse events. 1.4 Maintain data on the medical device products held by the holder in the information databases. 1.5 Cooperate with medical device regulatory authorities and surveillance agencies to conduct adverse event investigations. 1.6 Conduct continuous research on the safety of marketed medical devices and write regular product risk evaluation reports as required. 1.7 Conduct priority monitoring work of medical device products as required. 1.8 Conduct publicity training of relevant regulations for medical device adverse event surveillance.
Departments and Personnel 2.1 The department shall be established or designated to be responsible for the medical device adverse events surveillance, equipped with office space, equipment and funds. 2.2 Adverse event surveillance personnel should be provided that are appropriate for their size. In principle, the holders of the Class III medical device marketing licenses should be equipped with full-time personnel, and the holders of the Class II medical device marketing licenses should be equipped with relatively stable personnel. The surveillance personnel should be trained in relevant professional training and have the following basic conditions: 2.2.1 Familiar with regulations related to medical device adverse event surveillance. 2.2.2 Familiar with the medical device held. 2.2.3 Have good communication and coordination skill.
Management System To perform medical device adverse events surveillance activity, the following relevant management systems should be developed and included as part of the medical device quality management system, including: 2 3.1 Medical device adverse event surveillance department and personnel duties. 3.2 Work procedures for collection, investigation, analysis, evaluation, reporting, control, etc. of medical device adverse events. 3.3 Group medical device adverse event emergency response procedure. 3.4 Regular risk evaluation system for post-market medical device products. 3.5 Medical device priority monitoring procedures. 3.6 Medical device adverse event surveillance training system. 3.7 Medical device adverse event monitoring record and file management system. 3.8 Medical device database maintenance work system. 3.9 Other relevant systems.
Work Content and Procedures 4.1 Isolated Adverse Event Reporting and Evaluation 4.1.1 Collection 4.1.1.1 Effective information collection channels for medical device adverse events should be established according to product characteristics. For example, an adverse event collection module can be set up based on the company’s website for collection, or all medical device adverse events that are actively collected by distributors and the device operating units through user follow-up. It can be collected through the mobile APP created by the company, or through user complaints, literature reports, and relevant information issued by domestic and foreign regulatory authorities. It should be conducted according to the guidelines for the collection and reporting of isolated adverse event of medical device marketing license holder issued by the medical device regulatory authorities. 4.1.1.2 Users should be informed of the collection of medical device adverse events, such as telephone, fax, website, etc. 4.1.2 Reporting and Evaluation 4.1.2.1 Companies should be registered as users of the National Medical Device Adverse Event Surveillance System, and timely update product registration information and contact information; through this system, reporting medical device adverse events as required. 4.1.2.2 Companies should follow the principle that reporting if suspicious, and the content of the reporting should be authentic, complete and accurate. The scope of the reporting includes a medical device adverse event that causes or may cause serious injury and death, or a product failure that has not occurred but may cause serious injury and death. Innovative medical devices should report all medical device adverse events during the first registration period. Reporting should be in accordance with the guidelines for the scope of medical device adverse event report issued by the medical device regulatory authority. 4.1.2.3 Medical device adverse events that resulted in serious injury, might result in serious injury or death should be reported within 20 days from the date of discovery or awareness, and deaths should be reported within 7 days. If an adverse event occurs outside China that 3 causes or may cause serious injury or death, the domestic legal agent or the license holder shall report within 30 days from the date of discovery or awareness. The format and content of the reporting form are detailed in Annex 1. 4.1.2.4 If the marketing license holder is aware or informed of a suspicious medical device adverse event, he/she shall immediately investigate the cause, analyze and evaluate the medical device adverse event that causes or may cause serious injury and death, and report the evaluation result within 45 days after the adverse event is reported, or within 30 days if it is a report of death. Through the evaluation of isolated adverse events, if the product is likely to be risky, product risk evaluation and corresponding control measures should be taken. Conducting product risk evaluation on products should be in accordance with the guidelines for product risk evaluation of marketing license holders issued by the medical device regulatory authorities 4.2 Group Adverse Event Reporting and Processing 4.2.1 After discovered or be awarded of the group medical device adverse events, the companies must report to the local provincial drug regulatory authority and the public health administration department within 12 hours. Report to the superior administration or departments if necessary. Submit case reports within 24 hours for each incident. 4.2.2 Companies should conduct field investigations, understand the event progress, collect product-related information, clarify the cause of the incident, write an investigation report and report it to the provincial and local regulatory authorities and monitoring agencies within 7 days. The survey should include product quality status, event-to-product relevance, usage operations, and compliance within the distribution process. Self-inspection should include procurement, manufacturing management, quality control, tracking of the same model and the same batch of products, etc. 4.2.3 According to the investigation reports, the company shall evaluate the product safety based on the literature data, retrospective analysis and product risk factors; according to the evaluation results, measures such as recall and suspension of manufacture and sales shall be adopted, and the risk information shall be released in time and reported to the local drug surveillance and administration department 4.3 Periodic Risk Evaluation Report The holder shall conduct continuous research on the safety of the marketed medical devices, summarize and analyze the adverse event reports, monitoring materials and risk information at domestic and abroad, evaluate the risks and benefits of the products, and record the risk control measures adopted. This approach shall be implemented according to the Code for Writing Periodic Risk Evaluation Report for Medical Device Holder issued by medical device surveillance department. 4 4.4 Priority Monitoring The holders of the marketing licenses participating in the priority monitoring process shall formulate the implementation plan for the priority monitoring of the products of the company, and implement the guidelines for the priority monitoring of medical device adverse events promulgated by the medical device regulatory authorities according to the requirements of the regulatory authorities at or above the provincial level. 4.5 Record and Document Management 4.5.1 The monitoring system and records of medical device adverse events should be kept and the monitoring documents of the company should be established. 4.5.2 The records shall include: Medical Device Adverse Event Report Form, Medical Device Adverse Events of Serious Injury and Death Investigation Report, Product Risk Evaluation Report, Medical Device Periodic Risk Evaluation Report, Priority Monitoring Risk Evaluation Report, Group Medical Device Adverse Event Investigation Report. 4.5.3 Records shall be kept for 2 years after the expiration date of the medical device and not less than 5 years, and the records of medical device with no expiration date shall be kept for not less than 5 years; monitoring records of implanted and large active medical devices shall be permanently stored. 4.6 Database Maintenance 4.6.1 The marketing license holder shall input the relevant information of the product into the company user database within 30 days after obtaining the product registration or filing proof for the first time. 4.6.2 The relevant information of the product should be put into the company user database within 45 days if the company continues or changes the registration.
