Project

New regulations

Old regulations

Explanation

Scope of Application

2. Scope of Application
Applicable to registrants who carry out monitoring of medical device adverse events in the People's Republic of China. The registrant bears the main responsibility for monitoring medical device adverse events. The registrant shall register as a user of the National Medical Device Adverse Event Monitoring Information System (hereinafter referred to as the "system"), report medical device adverse event related information through the system, and maintain user and product registration information in a timely manner.

III. (i) Responsibilities and obligations to be performed
Medical device manufacturing enterprises, distributor, users, citizens, legal persons, other relevant social organizations and medical device adverse event monitoring technical institutions.

1. The registrant will assume the main responsibility for monitoring medical device adverse events.
2. Exclude "Distributor", "users", "citizen legal persons", and "adverse event monitoring technical institutions".

Management system of registrant on PMS

4.1 Members and scope of work of the leading group of medical device adverse event monitoring
4.2 Staff requirements and work items of the adverse event monitoring work department
4.3 Training management of adverse event monitoring
4.4 Adverse event investigation specifications
4.5 Emergency handling of adverse events4.6 Adverse event monitoring record management

(3) Have a professional background in medicine and medical devices;
(4) Familiar with the relevant informationof the company's products;
V. (ii) Institutional setup and personnel requirements recommend that the local (city) and county-level personnel should be more than 4 and 2 full-time personnel; the provincial level recommends more than 10 full-time personnel.
 

1. The new regulations require enterprises to set up leadership groups to be responsible for and require regular meetings and assessments.
2. The new regulations attach importance to the monitoring system of registrant enterprises
3. Strengthen the training of relevant personnel and set up assessments.
4. The process and scope of monitoring work within the registrant enterprise are required.

Individual adverse event report

5.1 cases of medical device adverse events
Medical device adverse event reporting should follow the principle of suspicious reporting. The content of the report should be true, complete, and accurate, and adverse events of medical devices that cause death, serious injury, or may cause serious injuries or death should be reported; innovative medical devices should report all adverse events of medical devices within the first registration cycle.
5.1.2 Report of adverse events of medical devices
If the registrant discovers or learns about suspicious medical device adverse events, it shall immediately investigate the cause, and those who cause death shall report within 7 days; those who cause serious injury, or may cause serious injury or death, shall report within 20 days. If an adverse event of a medical device that causes or may cause serious injury or death occurs overseas, the agent designated by the overseas registrant and the domestic medical device registrant shall report it within 30 days from the date of discovery or knowledge.
5.1.4 Analysis and evaluation of medical device adverse events
The event leading to death should be within 30 days, and the event leading to serious injury, possible serious injury or death should be reported to the provincial monitoring agency where the registrant is located within 45 days. If there are new discoveries or cognitions about the situation of the incident and the evaluation results, a supplementary report shall be provided.

3. (1) Case report (suspicious medical device adverse event report)
For suspicious medical device adverse events that lead to death, medical device manufacturers should fill out the "Suspicious Medical Device Adverse Event Report Form" (see Annex 1 for reporting requirements) within 5 working days from the date of discovery or knowledge, and report to the local medical device Incident monitoring technical agency report.
For suspicious medical device adverse events that lead to serious injury, and may lead to serious injury or death, the medical device manufacturer should fill out the "Suspicious Medical Device Adverse Event Report Form" within 15 working days from the date of discovery or knowledge to report to the local medical device. Incident monitoring technical agency report.
…

. The stated situation should be completed within 20 working days after the submission of the suspicious medical device adverse event report. If the medical device manufacturer believes that the incident in the suspicious medical device adverse event report is analyzed.

1. The new laws and regulations adhere to the principle of suspicious reporting, which speeds up the response to adverse events.
2. The new regulations make specific requirements for innovative medical devices.
3. Adjust the reporting time of individual adverse events
4. The new regulations require enterprises to report serious injuries or deaths of medical device adverse events that occurred overseas.
4. The new regulations cancel the "Supplementary Report Form for Adverse Events of Medical Devices", requiring that the evaluation results be reported within 30 days. If there are new discoveries, supplementary reports should be made.

Group Medical Device Adverse Events

5.2.1 The registrant shall immediately suspend production and sales after discovering or learning about adverse events of group medical devices, and notify the user to stop using related devices.
5.2.2 The registrant shall report the drug regulatory department and the competent health department of the province (autonomous region, municipality directly under the Central Government) where the adverse event occurred within 12 hours by telephone or fax. For each event, it shall also be a case-by-case event within 24 hours. 
5.2.3 The registrant quickly carried out the investigation and self-examinationof the production quality management system, and reported to the drug regulatory department and monitoring agency of the province (autonomous region, municipality directly under the Central Government) where the enterprise is located and where the adverse event occurred within 7 days.

3. (2) After discovering or knowing sudden and mass medical device adverse events, the medical device manufacturer fills out and submits the "Suspicious Medical Device Adverse Event Report Form" within 24 hours.

1. The new regulations require that manufacturers take immediate measures after group adverse medical device incidents occur.

2. Be more specific about the notification time of the manufacturer and the individual adverse event report.

3. The manufacturer is required to conduct self-inspection of the system within a certain period of time and submit the self-inspection report to the designated local FDA and monitoring agency.

Risk Assessment Report

5.3 Periodic risk assessment report
5.3.1 For the medical device approved for registration or filing for the first time, the registrant shall complete the regular product risk assessment report of the previous year within 60 days after each full year. The periodic risk assessment report for the first category of medical devices shall be kept by the filing party for future reference.
5.3.2 The registrant shall obtain the periodic risk evaluation report of the registration cycle for the medical device that has been renewed for registration, and the registrant shall keep it for future reference.
5.3.4 The summary of medical device risk information in the periodic risk assessment report should be continuous and uninterrupted during its life cycle.

(2) Quarterly report
(3) Annual report
County-level medical device adverse event monitoring technical institutions should summarize the monitoring work of medical device adverse events of the previous year before the end of January of each year for the first-class medical device manufacturers, and keep them for future reference.

1. Adjust the submission date of periodic risk assessment reports for all classification products.
2. Registrant shall complete the regular risk assessment before renewal registration.
3. Delete the requirement for other official institution

Risk Control

5.5 Risk Control
5.5.2 The risk control measures that registrants can take mainly include stopping product production and sales and notifying relevant units to suspend use; implementing product recalls; issuing risk warning information; conducting self-inspection and rectification of production quality systems; revising instructions, labels and operations Manuals, etc.; improvement of process, design, product technical requirements and other measures that need to be taken.
5.5.5 For cases in which medical devices are subject to control measures due to adverse events overseas, the registrant (agent designated by the overseas registrant or domestic medical device registrant) shall, within 24 hours after being informed, control the situation and control of the overseas adverse events The status of the measures and the control measures to be taken within the territory shall be reported to the State Drug Administration and the National Center, and copied to the local provincial drug supervision and administration department, and the subsequent disposal shall be reported in time.

4. Control of Adverse Events
(3) Relevant investigations carried out by medical device manufacturing enterprises should take into account retrospective research on product design, self-examination of quality system, product stage risk analysis, literature on medical device safety risk research and accident site situation, relevant users, supervision Opinion of the department, if necessary, quality inspection of the product.

1. Clarify the risk control measures that registrants can take.

2. The registrant is required to notify NMPA about the update of the control measures taken for overseas adverse events within a certain period of time

Product Monitoring Files

4.6.3 The monitoring records should be kept until 2 years after the validity of the medical device, and the retention period without the validity period should not be less than 5 years. The monitoring records of implantable medical devices shall be kept permanently.
5.4 Key monitoring work
5.4.1 The registrant shall formulate the implementation plan of key product monitoring in accordance with the requirements of the drug regulatory department at or above the provincial level, and submit it to the drug regulatory department responsible for the key monitoring product for review and filing.
5.4.5 The registrant shall clarify the root cause of failure or injury in the risk event and evaluate the product risk. At the same time, organize internal or related industry experts to hold meetings according to product risk to further clarify their product risks.
5.4.7 The registrant shall regularly report the progress of work to the drug supervision and administration department undertaking key monitoring.
5.4.8 Innovative medical device products are automatically included in key monitoring. Innovative medical device registrants should submit product adverse event monitoring analysis and evaluation reports to the national monitoring agency every six months within the first registration cycle.

5. Medical device manufacturing enterprises should establish product monitoring files and keep medical device adverse event monitoring records
The records should be kept until 2 years after the indicated use period of the medical device, but the record retention period should be no less than 5 years.

The new regulations emphasize that the monitoring records of implantable medical devices should be kept permanently. Other recording requirements have not changed.
The new regulations strengthen the monitoring efforts and automatically include innovative medical products in key monitoring.

Other institutes

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III. the use of medical devices
(ii) Designated institutions and staffing requirements

The new regulations do not regard the user institution as the main responsibility, weakening the requirements for the user institution.

Reporting process

6.2 Flow chart of medical device adverse event report
6.2.1 Flow chart of individual adverse event report
6.2.2 Flow chart of group adverse event report

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Add the flowchart for adverse event report

Appendix

"Registrant Medical Device Adverse Event Report Form"
"Group Medical Device Adverse Event Report Form"

"Registrant Medical Device Adverse Event Report Form"
"Supplementary Report Form for Adverse Events of Medical Devices"
"Annual Summary Table of Adverse Events of Medical Devices"

Update adverse event report format