Decree 1 Annex 9 Guideline On Inspecting Medical Device Adverse Event Monitoring Activity (draft)
2021-06-11
Annex 9 Guidelines for the Inspection of Medical Device Adverse Event Monitoring Work for Marketing Authorization Holders （Draft）
Purposes To standardize the inspection of the medical device adverse event monitoring work of the Medical device marketing Authorization holder (hereinafter referred to as the “holder”), improve the quality of the holder’s medical device adverse event monitoring system, this guideline is developed in according with “Medical Device Adverse Event Monitoring and Re-evaluation Management.”
Inspection types 2.1 Routine inspection Routine inspection refers to the planned inspections, usually a systematic examination. One or several specific medical devices may be selected as an example to check the operation of the holder’s medical device adverse event monitoring system. Routine examinations usually include the following: 1. organization and personnel; 2. holder’ duties and obligations; 3. isolated adverse events; 4. groups of medical device adverse events; 5. periodic risk assessment reports; 6. primary monitoring; 7. Risk control 8 re-evaluation. For details of the inspection, please refer to the inspection points (see Annex 1). 2.2 For-cause Inspection For-cause inspection refers to a targeted inspection of the license holder due to one or more special issues to confirm the license holder’s violation of relevant regulations. The reason for starting the cause check is as follows: 2.2.1 Problems with the safety of medical devices 2 The medical device adverse event monitoring technology organization (hereinafter referred to as the monitoring organization) finds that the license holder’s product has a potential risk, or the license holder fails to discover or communicate the relevant product risk in time. 2.2.2 Failure to establish a monitoring system as required The system for monitoring and re-evaluating adverse events of medical devices was not established in accordance with the regulations. Organizations and personnel were not provided as required, and users of medical device adverse event monitoring information systems were not registered or actively maintained user information. 2.2.3 Failure to fulfill reporting responsibilities and related requirements It mainly includes: not actively collecting and evaluating medical device adverse events according to time limit requirements; medical institutions report adverse events and the license holders have not, and the numbers of reports have a large gap, that is, there are fraud reports or omissions, indicating that their main responsibilities have not been put in place. Submitting fraud reports; failing to carry out priority monitoring and re-evaluation of medical devices as required; failing to submit periodic risk assessment reports as required; failing to submit summary reports on monitoring, evaluation of adverse events for innovative medical device products as required; not cooperating with regulatory authorities and monitoring agency to conduct relevant investigations and control measures etc. 2.3.4 Other issues Delayed implementation or insufficient implementation of corrective measures, related problems found in other inspections, patient reports, complaints, etc.
Inspection plan When developing an inspection plan, the following factors should be considered: A. Relevant violations found in previous medical device adverse event monitoring work inspections or other inspections. B. Medical devices conditionally approved with additional safety requirements, such as approved with requirements for postmarketing evaluation, medical devices that are reviewed and approved through abbreviated route for clinically urgent needs or treatment of rare diseases. Innovative medical devices and devises with high risks should also be focused on. C. Other considerations should be considered: license holders who have never received training in medical device adverse event monitoring; license holders with more varieties and large sales volume; license holders who have obtained medical device approval 3 in China for the first time; License holders of changes in organization (such as mergers and acquisitions).
Location and time of inspection A. Determine the inspection location and time according to the purpose of the inspection and the actual situation of the department. Any location where the license holder is involved in the implementation of medical device adverse event monitoring may be examined to determine whether these departments are able to perform medical device adverse event monitoring. B. In case of the license holder’s main medical device adverse event monitoring work site is abroad, and database or medical device adverse event monitoring activities are carried out overseas, meantime the work place in China cannot be effectively confirmed whether the relevant work complies with the current laws and regulations, an overseas examination can be carried out.
Inspection 5.1 Preparing phase 5.1.1 Notice license holder The license holder shall be formally notified of the inspection prior to the filed implementation of the routine inspection. The license holder of the medical device registration certificate (file number) in the territory (including the domestic office in China or the agency in China entrusted by the foreign license holder of the imported medical device) shall be ready to accept the inspection at any time. For-cause inspection may not be notified in advance; it is ensured that the inspection can be carried out at a confirmed inspection location, and the information and/or documents required by the inspector, interviewers and explanations of relevant issues are provided during the inspection. 5.1.2 Develop a filed inspection plan Before carrying out filed investigation, the basic information of the license holder, the development of monitoring work, risk factors, etc. should be fully understood, and filed inspection plans should be formulated, including inspection objectives, specific varieties, scope, time, location, schedule, team members and responsibilities. The filed investigation time is generally 1 to 3 days, which may be shortened or extended as appropriate. The inspection team is generally composed of more than two inspectors, and the inspection team leader is in charge. 5.2 Filed investigation 4 5.2.1 Kick-off meeting At the beginning of the filed investigation, a kick-off meeting is held with the inspectors, the person in charge of the license holder, the person in charge of medical device adverse event monitoring, and related staff. The content includes confirming the inspection content, implementing the inspection schedule, determining the license holder’s contact person during the inspection period, and introducing the medical device adverse event monitoring system and work profile. 5.2.2 Carry out inspection (1) Inspection methods: inspection of documents, personnel interviews, computer system inspections, etc. (2) Contents of the inspection: According to the filed investigation plan, conduct a comprehensive inspection of the license holder’s medical device adverse event monitoring system or carry out targeted inspections on specific issues. (3) Inspection records: All inspections conditions (including the names and positions of the interviewed persons) and problems found in the inspections should be recorded. Where necessary, the license holder shall not save evidence in accordance with the requirements of relevant laws and regulations and shall promptly transfer the evidence to the regulatory authority at the place where the license holder is located. (4) The inspection team shall analyze and summarize the filed investigations and evaluate the problems found during the inspections objectively and fairly. 5.2.3 Summary: At the end of the filed investigation, the inspection team should hold a summary meeting to provide feedback to the license holder on the problems found. If the license holder disagrees with the problems found in the filed investigation, he may make appropriate explanations. For the problems found on the filed investigation (see Annex 2), all members of the inspection team and the person in charge shall sign and confirm, and each party shall hold one copy. 5.2.4 Inspection report: Within 10 working days after the filed investigation, the inspection team leader shall be responsible for organizing the completion of the inspection report, confirming that the filed investigation materials of the signature are attached, and reporting to the inspection organization. The inspection report includes the following aspects: 1. Check the overall situation of the inspection, such as the composition of the inspection personnel, the development of the inspection plan and the confirmation of the inspection site; 2. The basic situation of the license holder’s implementation of “Management of Medical Device Adverse Events Monitoring and Re-evaluation”; 3. Problems found; 4. Conclusions and recommendations. 5 5.2.5 Correction and review: The inspected license holder shall formulate a correction plan based on the problems found during the inspection, implement corrective and preventive measures, and give priority to urgent and/or major issues. The corrective measures shall be targeted, evaluable, feasible and time-limited. The license holder shall submit the correction plan within 20 working days after the inspection and submit the correction report within 6 months after the inspection. When necessary, the inspection organization may conduct a review to ensure that the license holder’s corrective and preventive measures are effectively implemented 5.2.6 Information sharing: Relevant problems found during the inspection are shared with departments such as medical device registration review board, audit department, audit and inspection department. 5.2.7 Information disclosure: Inspection results and regulatory measures shall be disclosed in a timely manner
