Section II Individual Medical Device Adverse Events

Article 25 In case of identifying or knowing any suspected medical device adverse event, MAHs shall immediately investigate the cause. Any event causing death shall be reported within 7 days; and any event causing severe injuries or possibly causing severe injuries or death shall be reported within 20 days.

In case of identifying or knowing any suspected medical device adverse event, medical device distributing enterprises, user facility shall promptly notify MAHs. Any event causing death shall be reported within 7 days and any event causing severe injuries or possibly causing severe injuries or death shall be reported within 20 days through the National Medical Device Adverse Events Monitoring Information System.

Article 26 In case of identifying any medical device adverse event causing or possibly causing severe injuries or death, other units and individuals other than MAHs, distributing enterprises and user facilityshall  report to either monitoring agencies or MAHs, distributing enterprises or the medical institutions providing treatment, and provide relevant medical records if necessary.

Article 27 The overseas MAHs of imported medical devices and the MAHs exporting domestic medical devices abroad shall voluntarily collect the adverse events of the products occurred abroad. For the adverse events causing or possibly causing severe injuries or death, the agents designated by overseas MAHs and the MAHs of domestically-produced medical devices shall report within 30 days upon the date of identification or notification.

Article 28 The monitoring agencies at the level of the municipality consisting of districts shall review the truthfulness, completeness and accuracy of the received medical device adverse event reports within 10 days upon the receipt date, and feed back to relevant MAHs promptly.

Article 29 After reporting medical device adverse events or knowing relevant medical device adverse events through the National Medical Device Adverse Events Monitoring Information System, MAHs shall carry out subsequent investigation, analysis and evaluation as required. The evaluation results of the events causing death shall be reported to local provincial monitoring agencies where MAHs locate within 30 days and the evaluation results of the events causing severe injuries or possibly causing severe injuries or death shall be reported to local provincial monitoring agencies where MAHs locate within 45 days. If the MAH has any new identification or notification of event information and evaluation results, it shall submit a supplementary reportas required.

Article 30 Local provincial monitoring agencies where MAHs locate shall complete the review of evaluation results within 10 days upon the receipt of evaluation results from MAHs, and if necessary, may carry out on-site investigation on the adverse events that cause or possibly cause severe injuries or death by entrusting or cooperating with the provincial monitoring agencies where adverse events occur. For the medical devices approved by the NMPA to be registered, national monitoring agencies shall also re-check the evaluation review results by provincial monitoring agencies, and if necessary, may organize investigation on the adverse events causing death.

Review and re-check results shall be fed back to MAHs. In case of any objection to the evaluation results of MAHs, MAHs may be required to carry out re-evaluation again.

Section III Group Adverse Event of Medical Devices

Article 31 In case of identifying or knowing group adverse events of medical device, MAHs, distributing enterprises, user facility shall report to the drug regulatory departments and health administrative departments of the provinces, autonomous regions and municipalities directly under the central government where adverse events occur via telephone or fax within 12 hours, and may make a skip-level report when necessary. At the same time, they shall report basic information of group adverse events of medical device through the National Medical Device Adverse Events Monitoring Information System, and report each event as individual case report within 24 hours.

The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where adverse events occur shall promptly notify the relevant information to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate.

Article 32 In case of identifying or knowing group adverse events of medical device, MAHs shall immediately suspend the production and sales, and notify user facility to immediately stop using relevant medical devices. At the same time, MAHs shall carry out investigation and self-inspection of production quality management system and report to the drug regulatory departments and monitoring agencies of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate and where the adverse events occur within 7 days.

Investigation shall include product quality profile, the correlation between theinjury and the product, and compliance of the operation in the use and circulation process. Self-inspection shall include procurement, production management, quality control, and tracking of the same model and same batch of products.

MAHs shall analyze the cause of the event, release risk information in a timely manner, and report the self-inspection and control measures taken to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate and where the adverse events occur, and shall recall relevant medical devices when necessary.

Article 33 In case of identifying or knowing group adverse events of medical device, medical device distributing enterprises and user facility shall notify MAHs within 12 hours, rapidly carry out self-inspection and cooperate with MAHs to carry out the investigation. Self-inspection shall include product storage, tracing of circulation process, and tracking of the products of the same model and same batch. Self-inspection of user facility shall also include whether the use process meets the operational specification and product instruction requirements. Medical device distributing enterprises and user facility shall suspend the sales and use of the medical devices when necessary and assist relevant units in taking relevant control measures.

Article 34 After knowing the group adverse events of medical device that occurs within their respective administrative regions, the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall promptly carry out on-site investigation jointly with the health administrative departments at the same level, and the drug regulatory departments of relevant provinces, autonomous regions and municipalities directly under the central government shall cooperate. Investigation, re-evaluation and handling results shall be promptly reported to the NMPA and the Health Administrative Department of the State Council, and copied to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central governmentwhere MAHs locate.

Article 35 For the group adverse event of medical devices causing serious consequences on a national scale and causing severe injuries or death and other serious consequences, the NMPA shall carry out relevant investigations jointly with the Health Administrative Department of the State Council. National monitoring agencies shall be responsible for on-site investigation while drug regulatory departments and health administrative departments of relevant provinces, autonomous regions and municipalities directly under the central government shall cooperate.

The investigation content shall include the occurrence of medical device adverse events, use of medical devices, diagnosis and treatment of patients, previous similar adverse events, production process of products, storage and circulation of products and tracking of the products of the same model and same batch.

Article 36 National monitoring agencies and relevant drug regulatory departments and health administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall, within 5 days upon the completion of an investigation, conduct technical evaluation on product risks according to the investigation and propose the recommendations on control measures, form investigation report and submit it to the NMPA and the Health Administrative Department of the State Council.

Article 37 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where MAHs locate may carry out on-site inspection on the MAHs associated with group adverse events. The NMPA may, when necessary, carry out on-site inspection on the overseas MAHs associated withgroup adverse events.

The on-site inspection shall include operation of production quality management system, product quality profile and production process as well as the tracking of products of the same model and same batch.

Section IV Periodic Risk Evaluation Report

Article 38 MAHs shall conduct continuous research on the safety of medical devicesonce they are on the market, summarize and analyze the adverse event reports, monitoring data and domestic and overseas risk profile of products, evaluate its  risks and benefits, record the risk control measures taken and completepost-market periodic risk evaluation report.

Article 39 MAHs shall, from the date of the first approval for registration or filing, complete the post-market periodic risk evaluation report in the previous year within 60 days after one full year. For those approved by the NMPA to be registered , the report shall be submitted to national monitoring agencies; for those approved to be registered at  drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government, the report shall be submitted to local provincial monitoring agencies. Periodic risk evaluation report of Class I medical devices shall be kept by MAHs for future reference.

For the medical device with the approval for registration renewal, periodic risk evaluation report of this registration period shall be completed when the application for next registration renewal is submitted, and shall be kept by MAHs for future reference.

Article 40 The monitoring agencies above provincial level shall organize the review of the post-market periodic risk evaluation reports of medical devices received. They shall, when necessary, provide feedback of the review opinions to MAHs.

Article 41 Provincial monitoring agencies shall conduct comprehensive analysis on the post-market periodic risk evaluation reports received and submit the statistical information and analysis and evaluation results of the post-market periodic risk evaluation reports of the previous year to national monitoring agencies and local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government prior to May 1 each year.

National monitoring agencies shall conduct comprehensive analysis on the post-market periodic risk evaluation reports received and the statistical information and analysis and evaluation results submitted by provincial monitoring agencies, and submit the statistical information and analysis and evaluation results of the post-market periodic risk evaluation reports of the previous year to the NMPA prior to July 1 each year.

Chapter IV Intensive Surveillance

Article 42 The drug regulatory departments at provincial level or above may organize intensive surveillance on the medical device, and strengthen post-market risk study of medical devices.

Article 43 The NMPA shall determine the medical device varieties under intensive surveillance jointly with the Health Administrative Department of the State Council, organize to develop intensive surveillance project scheme and supervise the implementation.

National medical device varieties under intensive surveillance shall be determined according to the medical device registration, adverse event monitoring, supervisory inspection and testing and based on risk degree and product use.

National monitoring agencies shall organize the implementation of intensive surveillance project of medical devices and complete relevant technical report. The drug regulatory departments may take necessary management measures according to the risks identified in the monitoring.

Article 44 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government may, in accordance with the requirements for supervision and administration of medical device within their respective administrative regions, carry out provincial intensive surveillance project on Class II medical devices registered and Class I medical devices filed within their respective administrative regions by referring to Article 43 of the Provisions.

Article 45 MAHs of the medical device varieties under intensive surveillance shall, in accordance with requirements in intensive surveillance project of medical devices, carry out relevant works, voluntarily collect the adverse event reports of products and relevant risk information, write risk evaluation report and submit the report to authorities organizing the intensive surveillance project as required.

Article 46 The drug regulatory departments at provincial level or above may designate the units with certain qualifications to be monitoring sentinels to voluntarily collect intensive surveillance data. Monitoring sentinels shall provide the use information of medical device varieties under intensive surveillance, voluntarily collect and report adverse event monitoring information, organize or recommend relevant experts to carry out or to cooperate with monitoring agencies to carry out scientific research related to risk evaluation.

Article 47 MAHs of innovative medical devices shall strengthen voluntary monitoring of innovative medical devices, formulate product monitoring plans, voluntarily collect relevant adverse event reports and product complaint information, and carry out investigation, analysis and evaluation.

MAHs of innovative medical devices shall, within the first registration cycle, submit analysis, evaluation and summary report of product adverse event monitoring to national monitoring agency every half a year. In case of identifying any possible serious defects of a medical device, national monitoring agency shall promptly report to National Medical Products Administration.