Decree 1 Annex 5 Collection And Reporting Of Medical Device Adverse Events For Marketing Authorization Holder Guiding Principles (draft)
2021-06-11
Annex 5 Collection and Reporting of Medical Device Adverse Events for Marketing Authorization Holder Guiding Principles (Draft)
Purposes For the purpose of regulating the collection and reporting of medical device adverse events for medical device marketing authorization holders, these measures are developed in accordance with the “Administrative Measures for Monitoring and Reassessing Adverse Events of Medical Devices” (State Administration for Market Regulation, Order No.1)
Collection of adverse events Isolated medical device adverse events refer to death and serious injury events involving a single patient or operator that may be associated with a medical device, hereinafter referred to as “adverse events.” The case report of medical device adverse events refers to the process in which the marketing authorization holder fills in the information related to the medical device adverse events and reports through the National Medical Device Adverse Event Monitoring Information System, hereinafter referred to as the “Case Report”. Marketing authorization holders should establish a collection of adverse event information for medical device operators, users (medical institutions) and patients, actively collect academic literature, post-marketing adverse events, and expand information collection on the Internet, digital media, and social platforms. 2.1 Distributor The marketing authorization holder should actively collect information on adverse events from medical device operators and ensure that the business is aware of effective ways to report adverse events to them. The marketing authorization holder shall clarify the responsibility for reporting the adverse events of the enterprise in the form of signing the entrustment contract and train the relevant personnel of the operating enterprise to understand the objectives, methods, contents and storage requirements of the collection of adverse event information. Marketing authorization holders should regularly assess the ability of operating companies to fulfill their information collection responsibilities and take necessary measures to ensure the quality of information collection. 2.2 Device operating unit (Medical institutions) The marketing authorization holder shall designate personnel to collect information on adverse events occurring in the device operating unit through daily visits to maintenance personnel, or by e-mail or fax. The above communication should be 2 carried out regularly, accurately recorded and saved. When the marketing authorization holder or his distributor signs a medical device purchase and sale contract with the user, the user should be fully informed the holder’s responsibility for reporting adverse events, the user should be encouraged to report adverse events to them, and the marketing authorization holder should jointly develop plan for collecting information on adverse events in the device operating unit. 2.3 patients The contact number published by the marketing authorization holder in the medical device manual and label is an important way for the patient to report an adverse event, make a complaint or consult, and the phone should be kept open. The marketing authorization holder is encouraged to set up a special adverse event report phone (such as 400 hotline). The marketing authorization holder should inform the public of the call and its function in an effective manner. If the phone number is changed, it should be updated in the manual and label. The marketing authorization holder shall designate a person to answer the phone and collect information on adverse events reported by the patient or other individuals (such as doctors, users, lawyers). 2.4 Academic literature The scientific or medical literature is also one of the sources of adverse event information, and the marketing authorization holder should report adverse events found in the literature search. The marketing authorization holder shall establish a literature search specification or procedure to regulate the frequency of search, time range, source of the literature, type of document, and search strategy. Marketing authorization holders should systematically review the widely used literature search database. Common domestic databases include China Knowledge Network, Weipu Network, Wanfang Database, etc. Foreign databases include PubMed, Embase, Ovid, etc. The types of literature related to adverse events include: case reports, case series, review of adverse events, etc. In addition, clinical efficacy and safety studies, metaanalysis, etc. may also contain information on adverse events. The marketing authorization holder should develop a reasonable search strategy to ensure the comprehensiveness and accuracy of the search results, and the time range of the search should be continuous. For first-in-market devices, innovative devices and highrisk devices, marketing authorization holders should increase the frequency of searches enlarge the range of database retrieved. 2.5 Post-marketing studies Post-marketing studies or projects initiated by marketing authorization holders include: post-marketing studies with the primary purpose of understanding the safety and efficacy of medical devices, and patient –supporting programs, market research, and patient education activities with marketing as the primary purpose. Adverse events found in these activities should be collected and reported as required. Both the marketing authorization holder and the contract research unit can report adverse 3 events, in order to avoid duplicate report, license holders and the research unit should clearly report the subject in the relevant agreement. In principle, the subject of reporting is the marketing authorization holder, but the marketing authorization holder must not interfere with the reporting behavior of the research unit (for any reason). 2.6 Other ways In addition to the above, the marketing authorization holders also need to collect reports on adverse events discovered or known through other means, such as the Internet and related channels. Marketing authorization holders should collect information on adverse events on the websites they initiate or fund. For adverse events known from other websites, the marketing authorization holder should consider whether to report as appropriate. Marketing authorization holders should use the company’s website to collect information on adverse events, such as creating a dedicated path for reporting adverse events on the website, providing methods for reporting, forms of reporting, and guidance of reporting. The print media, digital media, social media/platforms initiated or hosted by the holders, such as corporate public WeChat accounts, Weibo, forums, case sharing meetings, etc., are also sources for collecting information on adverse events.
Processing of adverse events In order to ensure the collection, transmission, accuracy and traceability of reporting adverse events, the marketing authorization holder shall establish and maintain a record of the collection and reporting of adverse event information and verify and confirm the adverse events. 3.1 Record For directly discovered adverse events, the marketing authorization holder should fully obtain relevant information, including the occurrence of adverse events, the use of the device, the patient’s condition, the suspected and combined use of the drug, etc. If there exists difficulty, the marketing authorization holder should try to obtain more important information for risk assessment. For adverse events indirectly through email, letter, telephone, doctor interview, etc., the marketing authorization holder shall make the original record, and the recorded content shall include the date of the record, the rapporteur, and providers for other information, in addition to the adverse event information. The original record can be a paper record, or it can be an electronic document, a recording, or a screenshot of a website. For adverse events known in the literature search, the date of retrieval, personnel, search strategy, etc. should be recorded, and the original documents obtained by the search should be saved. If the relevant information is not retrieved, it should be recorded. Records should be truthful, accurate, objective and well preserved. The marketing authorization holder shall number the adverse event records and the number shall be continuous and may be traced back to the record according to the number. 4 3.2 Transmission The marketing authorization holder should specify the time limit for the delivery of adverse events to ensure the timeliness of the report are met. Record information should be kept authentic and complete in the relevant departments and personnel delivery. All missing information and changes to the original data should be noted. 3.3 Verification The marketing authorization holder shall review the authenticity and accuracy of the adverse event information and, if in doubt, verify the relevant information. If the adverse event comes from a cooperative unit other than the holder, such as a business enterprise, a device operating unit, a literature search institution, a research cooperation unit, etc., there should be binding provisions in the agreement between the parties to ensure that the information collected by the partner is true and accurate. It is the responsibility of the marketing authorization holder to check or review the information on adverse events provided by the partner and to be responsible for the quality of adverse event reports submitted to the regulatory authorities.
