Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

(SAMR Decree No.1)

   

Issued on August 31, 2018

The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1, 2019.

 

Zhang Mao, Minister of State Administration for Market Regulation

Ma Xiaowei, Minister of National Health Commission

August 13, 2018

   

 

Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

 

Chapter I General Provisions

Article 1 In order to strengthen monitoring and re-evaluation of medical device adverse events, promptly and effectively control post-market risks of medical devices and ensure human health and life safety, the Provisions is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices.

Article 2 The Provisions applies to the monitoring, re-evaluation, supervision and administration of medical device adverse events within the territory of the People's Republic of China.

Article 3 Medical device marketing authorization holders (hereinafter referred to as MAHs) shall possess the capacities of quality management and corresponding responsibilities to ensure that the medical devices are safe and effective, establish medical device adverse event monitoring system and directly report medical device adverse events to medical device adverse event monitoring agencies (hereinafter referred to as monitoring agencies). Distributing enterprises and user facility of medical device authorized by MAHs shall report medical device adverse events to MAHs and monitoring agencies.

MAHs shall evaluate the identified adverse events, improve the product quality based on evaluation results and report the evaluation results and measures for quality assurance to monitoring agencies; where review and approval by the original registration authority is required, application shall be submitted in accordance with the regulations.

Agents designated by overseas MAHs shall undertake adverse event monitoring of the imported medical devices sold within the territory of China and cooperate with overseas MAHs to fulfill the obligation of re-evaluation.

Article 4 The terms in the Provisions are defined as follows:

(I)  MAHs of medical device refer to the holders of medical device registration certificate and filing certificate, namely, medical device registrants and filing persons.

(II)  Medical device adverse event refers any harmful event occurred while using marketed medical devices under their normal usage that causes, or is likely to cause, harm to human body.

(III)  Serious damage is defined as the damage that one of the following situations is met:

1.  Life threatening;

2.  Causing permanent harms to body function or injuries to body structure;

3.  Medical measures are required to avoid the above-mentioned permanent harms and injuries.

(IV)  Group adverse event of medical device refers to the events occurred by the same medical device during its use that causes harm or threat for the health or life safety of a certain amount of population within a relatively concentrated time and area.

(V)   Medical device adverse event monitoring refers to the process of collection, reporting, investigation, analysis, evaluation and control of medical device adverse event.

(VI)  Intensive surveillance for medical device refers to the periodic monitoring activities which are performed actively for studying the post-market risks, characteristics, severity, and incidence of some variety or product.

(VII)  Medical device re-evaluation refers to the process of re-evaluating the safety and effectiveness of medical devices registered/filed and sold on the market and taking corresponding measures.

Article 5 National Medical Products Administration (hereinafter referred to as the NMPA) shall establish the National Medical Device Adverse Event Monitoring Information System and strengthen the construction of medical device adverse event monitoring information network and database.

Monitoring agencies designated by the NMPA (hereinafter referred to as national monitoring agencies) shall be responsible for unified management of all the information of medical device adverse events collected and provide feedback of relevant monitoring information of medical device adverse events to relevant monitoring agencies, MAHs, distributing enterprises or user facilities.

Monitoring information related to product use risks shall be reported to Health Administrative Departments.

Article 6 Drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall establish and improve medical device adverse event monitoring system, be equipped with corresponding monitoring agencies and personnel and carry out medical device adverse event monitoring.

Article 7 Where units and individuals discover any medical device adverse event, they have the right to report to authorities of drug supervision and administration (hereinafter referred to as drug regulatory departments) or monitoring agencies.

 

Chapter II Responsibilities and Obligations

Article 8 The NMPA shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation nationwide, organize the investigation and handling of group adverse events of medical device that has great influence nationwide and causes severe injuries or death and other serious consequences jointly with the Health Administrative Departments of the State Council, and take emergency control measures according to law.

Article 9 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation within their respective administrative regions, organize the investigation and handling of group adverse events of medical device that occurs within their respective administrative regions jointly with the health administrative departments at the same level and relevant authorities, and take emergency control measures according to law.

The drug regulatory departments at the level of the municipality consisting of districts or county level shall be responsible for medical device-related adverse event monitoring within their respective administrative regions.

Article 10 Drug regulatory departments shall guide and supervise subordinate drug regulatory departments in conducting supervision and administration on medical device adverse event monitoring and re-evaluation.

Article 11 Health administrative departments of the State Council and health administrative departments at all levels shall be responsible for supervision and administration of user facility of medical device related to medical device adverse event monitoring, urge user facility of medical device to carry out relevant medical device adverse event monitoring work and organize inspection, strengthen  assessment of medical device adverse event monitoring, and take relevant control measures for medical device adverse events within their responsibility according to law.

Superior health administrative departments shall guide and supervise subordinate health administrative departments to carry out the supervision and administration related to medical device adverse event monitoring.

Article 12 National monitoring agencies shall be responsible for receiving medical device adverse events information reported by MAHs, distributing enterprises and user facility, assume relevant technical works related to medical device adverse event monitoring and re-evaluation nationwide; be responsible for the construction, maintenance and information management of national network and database of monitoring information of medical device adverse event, organize to develop technical specifications and guidelines, organize the investigation, evaluation and feedback of relevant adverse events information of the medical devices approved by the NMPA to be registered, summarize, analyze and guide relevant adverse events information of the medical devices approved by local drug regulatory departments above municipal level to be registered or filed, and investigate and evaluate group adverse events of medical device that have great influence nationwide and cause severe injuries or death and other serious consequences.

Article 13 The monitoring agencies designated by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as provincial monitoring agencies) shall organize the technical works related to medical device adverse event monitoring and re-evaluation within their respective administrative regions; assume the investigation, evaluation and feedback of adverse events of the medical devices registered or filed within their respective administrative regions, and investigate and evaluate group adverse events of medical device that occurs within their respective administrative regions.

The monitoring agencies at the level of the municipality consisting of districts or county level shall assist in carrying out technical works related to medical device adverse event monitoring within their respective administrative regions.

Article 14 MAHs shall carry out continuous research on the medical devices already marketed, evaluate the risks, assume the responsibilities of medical device adverse event monitoring, take effective control measures based on the analysis and evaluation results, and fulfill the following main obligations:

(I)  Establishing a medical device quality management system that incorporates medical device adverse event monitoring and re-evaluation working mechanism;

(II) Equipped with the organization and personnel corresponding to the products to carry out relevant works of medical device adverse event monitoring;

(III) Proactively collecting and truthfully and promptlyreporting medical device adverse events to monitoring agencies according to the time limit stipulated in the Provisions;

(IV) Promptly investigating, analyzing and evaluating medical device adverse events occurred, and promptlytaking measures to control risks and release risk information;

(V)  Conducting continuous study on the safety of medical devices once they are on the market, and write periodic risk evaluation reports as required;

(VI) Actively carrying out medical device re-evaluation;

(VII) Cooperating with drug regulatory departments and monitoring agencies in investigation of medical device adverse events.

Article 15 In addition to fulfilling the obligations stipulated in Article 14 of the Provisions, overseas MAHs shall also establish information transfer mechanism with their designated agents to promptly exchange information related to medical device adverse event monitoring and re-evaluation.

Article 16 Medical device distributing enterprises and user facilities shall fulfill following major obligations:

(I) Establishing medical device adverse event monitoring working mechanism. Medical institutions shall also include medical device adverse event monitoring in medical institution quality management work priorities;

(II) Be equipped with the organization or personnel adapted to the scale of the business or use to carry out relevant works of medical device adverse event monitoring;

(III) Collecting medical device adverse events, promptly reporting to MAHs, and reporting to the monitoring agencies as required;

(IV) Cooperating with MAHs in the investigation and evaluation of medical device adverse events and medical device re-evaluation;

(V) Cooperating with drug regulatory departments and monitoring agencies in the investigation of medical device adverse events.

 

Chapter III Report and Evaluation

Section I Basic Requirements

Article 17 Medical device adverse events shall be reported based on the principle of "Report When in Doubt", that is, when an event is suspected to be a medical device adverse event, it shall be reported as a medical device adverse event.

The reporting content shall be authentic, complete and accurate.

Article 18 Any suspected medical device adverse events that have caused or possibly caused severe injuries or death shall be reported; for an innovative medical device, all the medical device adverse events shall be reported within initial registration period.

Article 19 MAHs, distributing enterprises and secondary medical institutions or above shall register as the users of the National Medical Device Adverse Events Monitoring Information System, voluntarily maintain the user information and report medical device adverse events. MAHs shall continuously track and handle monitoring information; in case of any change in product registration information, MAHs shall update the information in the system immediately.

Other user facilities are encouraged to register as the users of the National Medical Device Adverse Events Monitoring Information System and report the information related to adverse events.

Article 20 MAHs shall release the contact information such as telephone, correspondence address, email and fax, designate the contact person, and voluntarily collect the adverse event information from medical device distributing enterprises, user facility and users; In case of identifying or knowing any suspected medical device adverse event, MAHs shall report and evaluate the medical device adverse event directly through the National Medical Device Adverse Events Monitoring Information System and submit investigation report of group adverse events of medical device as well as periodic risk evaluation report.

In case of identifying orknowing any suspected medical device adverse event, medical device distributing enterprises and user facility shall notify MAHs and report it through the National Medical Device Adverse Events Monitoring Information System. In case of having no conditions for online report temporarily, MAHs shall report to local monitoring agency above county level in paper form. The monitoring agency shall make online reporting on their behalf.

Monitoring agencies at all levels shall make their contact information open such as telephone and correspondence address.

Article 21 MAHs shall analyze and evaluate the medical device adverse event monitoring information collected and informed and actively carry out the study on medical device safety. For the medical device with conditional approval, MAHs shall carry out relevant works according to risk control plan.

Article 22 MAHs, medical device distributing enterprises as well as user facility shall establish and keep medical device adverse event monitoring records. The records shall be kept until 2 years upon shelf life expiration of medical devices; for those without shelf life label, the record-keeping period shall not be less than 5 years. The monitoring records of implantable medical devices shall be kept permanently, and medical institutions shall keep them in accordance with the relevant provisions for medical records.

Article 23 Provincial monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices registered or filed within local administrative regions, propose recommendations on supervisory measures for identified risks, and report to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies within 30 days at each quarter end.

National monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices approved by the NMPA to be registered or filed and quarterly reports submitted by all the provinces, autonomous regions and municipalities directly under the central government, and if necessary, propose recommendations on supervisory measures to the NMPA.

Article 24 Provincial monitoring agencies shall yearly carry out Meta-analysis on the medical devices adverse event monitoring information registered or filed within local administrative regions, complete annual summary report, and submit it to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies prior to March 15 each year.

National monitoring agencies shall carry out Meta-analysis on the annual monitoring information of medical device adverse events nationwide, complete annual report and submit it to the NMPA by the end of March each year.

The drug regulatory departments at provincial level or above shall notify the annual reports to the health administrative departments at the same level.

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.

Chapter V Risk Control

Article 48 In case of identifying the medical devices with improper risks that may endanger human health or life safety through medical device adverse event monitoring, MAHs shall take following risk control measures according to the situations and report to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government where they locate:

(I) Stopping producing and selling associated products;

(II) Informing medical device distributing enterprises and user facilityto  suspend sales and use;

(III) Conducting product recall;

(IV) Releasing risk information;

(V) Carrying out self-inspection on production quality management system and make rectification for the relevant issues;

(VI) Revising the instructions, labels and operating manual, etc.;

(VII) Improving production process, design and product technical requirements etc.;

(VIII) Carrying out medical device re-evaluation;

(IX) Carrying out change registration or filing according to the regulations;

(X) Other risk control measures required.

MAHs shall promptly release the risks related to use safety of medical devices and disclose information to the public.

Article 49 Where drug regulatory departments believe that the control measures taken by MAHs are not sufficient to effectively prevent risks, they may take such measures as releasing warning information, suspending production, sales and use, ordering recall of  relevant products, requiring revision of  instructions and labels and organizing re-evaluation, and organize  supervision and inspection on MAHs.

Article 50 For devices-related group adverse events, the drug regulatory departments at provincial level or above shall, based on  risk profile , take the measures including suspending production, sales and use, and organize the supervision and inspection on MAHs, and release warning information and disposalinformation to the public promptly. After conclusion of technical evaluation, the drug regulatory departments at provincial level or above shall take further regulatory measures according to the relevant regulations and strengthen adverse event monitoring for medical devices of the same varieties.

The health administrative departments at the same level shall suspend the use of relevant medical devices in the medical institutions within their respective administrative regions and take measures to actively organize the treatment for patients. The relevant MAHs shall be cooperative.

Article 51 In case of identifying any unproper risk of medical devices during the evaluation and review of medical device adverse event reports, quarterly and annual summary report of adverse event reports, group adverse events evaluation, intensive surveillance and periodic risk evaluation reporting, the monitoring agencies above provincial level shall propose risk management opinions, provide timely feedback to MAHs and report to corresponding drug regulatory departments. Provincial monitoring agencies shall also report to national monitoring agencies.

The MAHs shall formulate and implement corresponding risk control measures taking into account risk management opinions received.

Article 52 The drug regulatory departments and health administrative departments at all levels may entrust medical device inspection agencies with corresponding qualification to inspect the products involved in medical device adverse events when necessary. A medical device testing institution shall perform the test promptly and issue the test report.

Article 53 Where imported medical devices are associated with medical device adverse events overseas, or domestically-produced medical devices are associated with medical device adverse events overseas with control measures taken, the designated agents of overseas MAHs or the MAHs of domestic medical devices shall, within 24 hours after being informed, report the information of overseas medical device adverse events, control measures and the control measures to be taken within the territory of China to the NMPA and national monitoring agencies, copy to the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government, and promptly report subsequentdisposal.

Article 54 Where suspected medical device adverse events are caused by inferior device quality, the drug regulatory departments shall take proper measures in accordance with relevant regulations of medical devices; where such events are caused by improper use of medical device, the health administrative departments shall take proper measures.

 

Chapter VI Re-Evaluation

Article 55 In case of any of following situations, MAHs shall voluntarily carry out re-evaluation and take corresponding measures based on re-evaluation conclusions:

(I) Cognitional changes of the safety and effectiveness of the medical device according to the development of scientific research;

(II) The monitoring and evaluation results of medical device adverse event indicate that the medical device may have defects;

(III) Other situations under which re-evaluation shall be performed as specified by the National Medical Products Administration.

Article 56 In case of carrying out medical device re-evaluation, MAHs shall, based on the product safety and effectiveness information learned after products are marketed, clinical data and use experiences, re-evaluate the summary information, study data, clinical evaluation materials, product risk analysis materials, product technical requirements, instructions, labels and other technical data and content in original registration materials of medical devices.

Article 57 Re-evaluation reports shall include product risk-benefit assessment, socio-economic benefit evaluation, technical progress evaluation and recommendations on measures to be taken.

Article 58 In case of voluntarily carrying out medical device re-evaluation, MAHs shall develop re-evaluation plan. Where control measures are required through re-evaluation, MAHs shall submit the re-evaluation report within 15 days upon the formation of re-evaluation conclusion. For medical devices approved by the NMPA to be registered or filed shall submit the report to national monitoring agencies; MAHs of other medical devices shall submit the report to the provincial monitoring agencies where MAHs locate.

Where MAHs fail to perform the obligation of re-evaluation on medical devices as stipulated, the drug regulatory departments at province level or above shall order such holders to carry out re-evaluation thereon. If necessary, the drug regulatory departments at the province level or above may directly organize re-evaluation.

Article 59 Where drug regulatory departments at provincial level or above order to carry out re-evaluation, MAHs shall submit the re-evaluation plan and re-evaluation report to the corresponding drug regulatory departments and monitoring agencies before implementation of re-evaluation and within 30 days upon the completion of re-evaluation.

Where the implementation period of re-evaluation plan exceeds 1 year, MAHs shall make annual report update each year.

Article 60 Monitoring agencies shall review the re-evaluation reports by MAHs and submit the review opinions to the corresponding drug regulatory departments.

Where the drug regulatory departments have objection to the re-evaluation conclusions by MAHs, which shall, in accordance with the requirements by drug regulatory departments, re-confirm the re-evaluation conclusions and carry out re-evaluation.

Article 61 Where drug regulatory departments organize to carry out medical device re-evaluation, the designated monitoring agencies shall formulate the re-evaluation plan, organize the implementation after the plan has been approved by the drug regulatory departments organizing re-evaluation, complete re-evaluation reports, and submit to corresponding drug regulatory departments.

Article 62 Where the re-evaluation results indicate that the registered or filed medical devices have defects that endanger personal safety, and cannot be eliminated or controlled risks through such measures as technical advances and revision of instructions and labels, or the risk/benefit ratio is unacceptable, MAHs shall voluntarily apply for the cancellation of medical device registration certificate or filing. In case MAHs do not apply for the cancellation of medical device registration certificate or filing, the original issuing authority shall cancel the medical device registration certificate or filing. The drug regulatory departments shall promptly release to the public the information related to the medical device registration certificate or filing cancelled.

The National Medical Products Administration may make the decision to eliminate the medical device variety based on the re-evaluation conclusion. The registration certificate or filing of eliminated products shall be cancelled by original issuing authority.

The medical device with the registration certificate or filing revoked shall not be manufactured or imported, distributed or used.

 

Chapter VII Supervision and Administration

Article 63 The drug regulatory departments shall, based on their responsibilities, supervise and inspect the medical device adverse event monitoring and re-evaluation carried out by MAHs and distributing enterprises, and supervise and inspect the medical device adverse event monitoring by user facility of medical device jointly with the health administrative departments at the same level.

Article 64 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall formulate supervision and inspection plan on medical device adverse event within the administrative region, and explicitly define inspection work focus and supervise the implementation.

Article 65 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall strengthen the training and assessment of staff engaging in medical device adverse event monitoring and re-evaluation within their respective administrative regions.

Article 66 The drug regulatory departments shall, in accordance with the requirements in the laws, regulations and specifications, supervise and inspect on the establishment and operation of adverse event monitoring system by MAHs. When necessary, the drug regulatory departments shall conduct extended inspection on enterprises entrusted by MAHs.

Article 67 In case of any of following situations, drug regulatory departments shall carry out the key inspection for MAHs.

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) If there is a big gap between the quantity of the adverse events that cause or possibly cause severe injuries or death reported by MAHs and those  reported by medical institutions, it indicates the entity responsibilities of MAHs have not been fully implemented;

(III) Concealing, missing to report or submitting false report;

(IV) Failing to cooperate with the drug regulatory departments in relevant investigation of medical device adverse events and control measures to be taken;

(V)  In case the safety and effectiveness of the product cannot be guaranteed due to failure to collect the safety-related information of product through adverse event monitoring as required, or failure to conduct post-market study and re-evaluation as required.

Article 68 Where MAHs fail to establish adverse event monitoring system and carry out adverse event monitoring and re-evaluation as required, fail to promptly take effective risk control measures in accordance with Article 48 of the Provisions, fail to cooperate with the drug regulatory departments in relevant investigation of medical device adverse events and control measures to be taken, the drug regulatory departments shall require them to stop production and make rectification, and take the control measure of stopping product sale when necessary.

Where the production or sale needs to be resumed, MAHs shall submit an application to the drug regulatory authority that makes the decision. After MAHs pass the on-site inspection by the drug regulatory departments, a decision of resuming production or sale shall be made.

Before submitting an application for resuming production or sale, MAHs may employ an independent third-party professional agency with corresponding qualification to conduct inspection for confirmation.

Article 69 The drug regulatory authority above provincial level should release in a unified manner the following medical device adverse event monitoring information:

(I)  Information on group adverse event of medical device;

(II) Alerts on medical device adverse event monitoring;

(III) Medical device adverse event monitoring information requiring regularly release;

(IV) Other medical device adverse event monitoring information that needs to be released in a unified manner.

 

Chapter VIII Legal Liabilities

Article 70 In any of the following circumstances for MAHs, in accordance with Article 68 of the Regulations for the Supervision and Administration of Medical Devices, the drug regulatory departments above the county level should order to make correction and give warning, and a fine between 5,000 RMB and  20,000 RMB should be imposed if MAHs refused to make correction; in serious circumstances, the production should be instructed to stop until the relevant certificates are revoked by the original issuing authority:

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) Concealing, missing to report or submitting false report;

(III) Failing to submit evaluation outcome reports or submit investigation reports of group adverse events of medical device in accordance with the time limits;

(IV) Failing to cooperate with drug regulatory departments and monitoring agencies in relevant investigation of medical device adverse events and control measures to be taken.

Article 71 In any of the following circumstances for medical device distributing enterprises and user facility, in accordance with Article 68 of the Regulations for the Supervision and Administration of Medical Devices, the drug regulatory departments and the health administrative departments above the county level according to their respective responsibilities should order to make correction and give warning, and a  fine between 5,000 RMB and  20,000 RMB should be imposed if MAHs refused to make correction; in serious circumstances, the production shall be ordered to stop until the relevant certificates are revoked by the original issuing authority:

(I) Failing to voluntarily collect and report medical device adverse events according to the time limits;

(II) Concealing, missing to report or submitting false report;

(III) Failing to cooperate with drug regulatory departments and monitoring agencies in relevant investigation of medical device adverse events and control measures to be taken.

Article 72 Where MAHs fail to carry out re-evaluation as required, conceal re-evaluation results, or fail to submit an application for cancellationas required, the drug regulatory departments at provincial level or above shall order them to make rectification and give a warning, and may impose a fine between 10,000 and 30,000 RMB.

Article 73 In any of the following circumstances for MAHs, the drug regulatory departments above county level should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction:

(I) Failing to establish medical device adverse event monitoring and re-evaluation mechanism according to related provisions;

(II) Failing to be equipped with the organization and personnel corresponding to the products to carry out the relevant medical device adverse event monitoring work as required;

(III) Failing to keep the records of adverse event monitoring or preserve the records for insufficient duration;

(IV) Failing to register as the user of the National Medical Device Adverse Events Monitoring Information System which shall be registered;

(V)  Failing to voluntarily maintain user information, or fail to continuously track and dispose monitoring information;

(VI) Failing to take corresponding control measures according to the situation of adverse events and release to the public;

(VII) Failing to write, submit or keep post-market periodic risk evaluation reports as required;

(VIII) Failing to submit overseas medical device adverse events and overseas control measures as required;

(IX) Failing to submit analysis, evaluation and summary report of innovative medical device products as required;

(X)  Failing to release contact information and voluntarily collect the information of adverse events;

(XI) Failing to carry out intensive surveillance on medical devices as required;

(XII) Other violations of the Provisions.

Article 74 In any of the following circumstances for medical device distributing enterprises and user facility, the drug regulatory departments and the health administrative departments above county level according to their respective responsibilities should order to make correction and give warning, and a fine between 5,000 RMB and 20,000 RMB should be imposed if MAHs refused to make correction.

(I) Failing to establish working system for medical device adverse event monitoring as required;

(II) Failing to be equipped with the organization and personnel corresponding to the scale of business or use to carry out relevant works of medical device adverse event monitoring as required;

(III) Failing to keep the records of adverse event monitoring or keep the records for insufficient duration;

(IV) Failing to register as the user of the National Medical Device Adverse Events Monitoring Information System as required;

(V)  Failing to promptly report to MAHs the medical device adverse events collected or learned;

(VI)  Failing to cooperate with MAHs in the investigation and evaluation of medical device adverse events;

(VII)  Other violations of the Provisions.

In case of identifying any using unit having violations specified in preceding paragraph, the drug regulatory departments shall transfer the case to the health administrative departments at the same level for disposition.

Where the health administrative departments make decision of administrative penalty for user facilities, it shall promptly notify the drug regulatory departments at the same level.

Article 75 MAHs, distributing enterprises and user facility report, investigate, evaluate and dispose medical device adverse events in accordance with the requirements of the Provisions to proactively eliminate or reduceserious consequence, they shall impose a lighter or mitigated punishment for the relevant violations in accordance with Law of the People's Republic of China on Administrative Penalties, and impose no punishment for those having mild violations and making timely correction without causing serious consequences but are not exempt from other legal liabilities according to laws.

Article 76  Where the drug regulatory departments, health administrative departments and monitoring agencies at all levels and their staff fail to fulfill   responsibilities in accordance with regulations, they shall be penalized in accordance with Article 72 and Article 74 of the Regulations for the Supervision and Administration of Medical Devices.

Article 77 Where MAHs, distributing enterprises and user facilities violate relevant regulations and thus causing damage to medical device users, they shall   assume compensation liability according to law.

 

Chapter IX   Supplementary Provisions

Article 78  The content of medical device adverse event report, risk analysis and evaluation report and statistical data are the basis for strengthening   supervision and administration on medical devices and guiding proper use, but shall not serve as the basis for medical disputes, medical litigation or handling quality accident of medical devices.

Those falling under medical accident or medical device quality problems shall be handled separately in accordance with the requirements in the relevant regulations.

Article 79  The Provisions shall be interpreted by the NMPA together with the Health Administrative Department of the State Council.

Article 80  The Provisions shall be put into effect as of January 1, 2019.