Guidelines for medical device registrants to conduct product adverse event risk assessment

1. Preface
In order to guide and standardize medical device registrants and recordholders (hereinafter referred to as registrants) to carry out post-marketing risk assessment of medical devices, these guiding principles are formulated in accordance with the Measures for the Administration of Adverse Event Monitoring and Reevaluation of Medical Devices (Order No. 1 of the State Administration for Market Regulation and the National Health Commission of the People's Republic of China) (hereinafter referred to as the Measures).The registrant referred to in these Guiding Principles has the same connotation as the holder of the medical device marketing license referred to in the Measures.

These guiding principles are the general requirements for the risk assessment of medical devices, and the specific problems not involved in them should be studied and determined from the actual situation. At the same time, with the improvement of regulations, changes in regulatory needs, the development of science and technology, and the accumulation of registrants' awareness of medical device risks, these guiding Principles will also be adjusted in a timely manner.

2. Scope of application

These guidelines are applicable to the registrant to carry out medical device adverse event monitoring within the territory of the People's Republic of China, to help them understand and master the basic requirements and work content of medical device risk assessment, and can also be used as a reference document for medical device adverse event monitoring institutions (hereinafter referred to as monitoring institutions) to carry out product risk assessment report review.

3. General requirements

The registrant shall conduct timely investigation, analysis and evaluation of the occurrence of medical device adverse events, and shall conduct product risk evaluation when it is found that there may be unreasonable risks in the reporting and evaluation of individual medical device adverse events, early warning signal disposal, adverse event summary analysis and other work.

Where the monitoring agency at or above the provincial level finds that the product may have unreasonable risks during the summary analysis of adverse event monitoring information, it may require the registrant to carry out product risk assessment.

The registrant shall complete the risk assessment within the planned time, and ensure that the data and information provided in the evaluation report are true, sufficient and reliable. If it is not possible to complete the evaluation on time, the relevant parties should be communicated in advance and the delayed information note should be annexed to the report.

4. Evaluate the job
Medical device risk assessment mainly includes but is not limited to the following aspects:
4.1 Investigation and verification of adverse events
4.1.1 Basic Product Information
It mainly includes product registration certificate number or record certificate number, intended use, domestic and foreign listing, product source, model specification, batch number or number, production date, expiration date, etc.

4.1.2 Adverse events

It mainly includes the occurrence time of adverse events, injury/device failure manifestations, adverse event consequences, and risk control measures taken.

4.1.3 Patient diagnosis and treatment information
If adverse events involve injury to patients, the diagnosis and treatment information of patients should be investigated and verified, mainly including age, gender, original disease, medication history, relevant signs and various examination data, treatment measures, and outcomes.
4.1.4 Product usage
It mainly includes operation records, the type and qualification of operators (whether they have received training before use), the use environment, the specific operation process (whether they refer to the operation guide or specifications), storage conditions, maintenance and maintenance conditions, combined drug/machine conditions, product use time/years, product (annual/quarterly/monthly) usage or frequency of use, and similar adverse events in the past The situation, etc.
4.2 Monitoring data and literature analysis
4.2.1 Analysis of domestic adverse event monitoring data

The registrant shall select appropriate analysis methods, summarize and analyze the adverse event reports collected by the national medical device Adverse event Monitoring information system and independently collected, and clarify the main adverse event performance of the product, the occurrence of adverse events of concern and their correlation with the product.

4.2.2 Analysis of overseas adverse event monitoring data
Where the product is listed overseas, the registrant shall summarize and analyze the adverse event information that occurred overseas and compare it with the domestic situation.
4.2.3 Literature analysis
The registrant shall search domestic and foreign literature databases, summarize the literature related to product risks, and analyze the adverse events and potential risk points reported in the literature.
4.2.4 Analysis of product manuals or operation manuals
The registrant shall analyze the contents of the prompt information and countermeasures related to this concern risk in the current product manual or operation manual.
4.3 Other risk information analysis
4.3.1 Analysis of production and circulation process
The registrant shall review whether there are any problems in the procurement process control, production process control, production facilities/equipment, process inspection and factory inspection, packaging, transportation and storage of raw materials or spare parts of the relevant batch/unit products. If there are no exceptions in the review, a brief overview is sufficient, and if an exception is found, a detailed explanation should be provided.
4.3.2 Analysis of complaint events
The registrant shall summarize and analyze the previous complaints of the product, focusing on the reasons for the occurrence of the incidents related to the risk of this concern and their correlation with the product.
4.3.3 Summary of previous risk control measures
The registrant shall summarize the control measures and reasons taken for the safety of the product at home and abroad.
4.4 Product Inspection

According to the needs of risk assessment, the registrant may inspect the relevant batch of retained sample products to analyze whether the products meet the registered or filed product technical requirements.

4.5 Risk analysis and evaluation
4.5.1 The registrant shall comprehensively analyze the causes of product failure or injury in adverse events from the aspects of design and development, production management, circulation and storage, operation and use, maintenance and after-sales service.
4.5.2 The registrant shall, based on the results of analysis and evaluation, determine the possible impact of the concerned risks on the overall safety of the product, and state that the control measures have been taken for the concerned risks.
4.5.3 The registrant shall evaluate whether the prompt information on this concern risk in the product manual or operation manual is sufficient and whether the current risk control measures are sufficient.
4.5.4 The registrant shall organize a meeting of internal or related industry experts according to the need of risk assessment, and listen to the experts' analysis opinions on the cause of the event and suggestions on risk control.
4.6 Risk Control
4.6.1 When the registrant confirms that unreasonable risks exist in the product through risk assessment, it shall take effective risk management measures to control risks in time. Common risk control measures include modifying the manual/label/operation manual, improving the production process/design/product technical requirements, stopping production/sales, recall, etc.
4.6.2 The registrant shall promptly report the risk control measures taken to the local provincial drug regulatory department, and the risk and disposal situation related to the safety of the equipment shall be disclosed to the public in a timely manner.
4.6.3 The registrant shall develop an evaluation plan for risk control measures and continuously track the implementation effect of the measures taken to ensure that the risks are effectively controlled.

5. Evaluation report writing
The product risk assessment report shall be written in Chinese, including cover, catalog, text, attachments and other parts.
5.1 Cover
The cover of the evaluation report should generally include the title, company name, contact address, postal code, fax, department responsible for product safety, contact person and contact information (including mobile phone, fixed phone, email, etc.), report completion time and other information (Annex 1).
5.2 Directories
The evaluation report catalogue should generally contain a secondary catalogue.
5.3 Text

The main contents of the evaluation report include background introduction, adverse event investigation and verification, monitoring data and literature analysis, other risk information, product test results, risk analysis and evaluation conclusions, risk control measures, etc. (See Annex 2 for the format).

5.3.1 Background
This part mainly explains the reasons for carrying out the risk assessment and the risks to be evaluated, and briefly describes the related work carried out in the evaluation process.
5.3.2 Investigation and verification of adverse events
This part should describe the investigation and verification in detail, including basic product information, adverse events, patient diagnosis and treatment information (if any), product use, etc.
5.3.3 Monitoring data and literature analysis
This part shall analyze in detail the domestic and foreign adverse event monitoring data, safety-related literature, as well as the contents related to the risk of this concern in the product manual or operation manual.
5.3.4 Other Risk information
This part mainly analyzes the production and circulation process and complaints, and summarizes the risk control measures and reasons taken in the past due to safety problems.
5.3.5 Product inspection results
If the product is reinspected, it shall be clear whether it meets the technical requirements of the product registered or filed. If the product has not been reinspected, the work has not been carried out.
5.3.6 Risk analysis and evaluation conclusion
This part comprehensively analyzes the causes of product failure or injury in adverse events, studies the impact of this concern risk on the overall safety of products, and puts forward risk control suggestions based on expert opinions (if any) and measures taken (if any).
5.3.7 Risk control measures
This part should describe the specific risk control measures to be taken according to the recommendations made in the evaluation conclusions, and explain the implementation effect tracking evaluation plan.
5.4 Accessories
The key information involved in the evaluation report should be submitted as the annex to the report, such as product inspection report, important literature, minutes of expert meetings, documents on risk control measures, etc.


6. Submission of evaluation reports
6.1 For product risk assessment caused by individual adverse event evaluation or early warning signal disposal of the national medical device adverse event monitoring information system, the registrant shall submit the evaluation report through the information system.
6.2 For the product risk assessment required by the provincial monitoring agency, the registrant shall submit the evaluation report to the provincial monitoring agency where the enterprise is located, and submit it to the National Adverse Drug Reaction Monitoring Center after review by the provincial monitoring agency.
6.3 For the product risk assessment conducted by the National Adverse Drug Reaction Monitoring Center directly notified to the registrant, the registrant shall submit the evaluation report to the National Adverse Drug Reaction Monitoring Center.

6.4 For the product risk assessment carried out by the registrant itself, if the evaluation results confirm that the product has unreasonable risks, the registrant shall timely submit the evaluation report to the provincial monitoring agency where the enterprise is located, and the provincial monitoring agency shall submit the evaluation report to the National Adverse Drug Reaction Monitoring Center after review.

7. Relevant instructions
7.1 The warning signals in these guidelines refer to the risk signals generated by the early warning analysis and management module of the National Adverse Event Monitoring Information System for medical devices.
7.2 On the basis of meeting the requirements of these Guiding Principles, the content of the evaluation report can be appropriately adjusted according to product characteristics and risk concerns.
7.3 The cover of the product risk assessment report shall be stamped with the official seal of the company.

7.4 Monitoring institutions at or above the provincial level shall review the product risk assessment report submitted by the registrant in accordance with the relevant requirements of the Measures, and if the review does not meet the requirements, the registrant shall improve or re-evaluate in accordance with the requirements.

Schedule 2: Report body reference format

(Product name) Risk assessment report