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.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.