Decree 1 Annex 7 Guideline On Focus Points When Monitoring Medical Device Adverse Events (draft)

Annex 7

1. Purpose
   In order to standardize the priority monitoring of medical device adverse events, and
   guide the monitoring agencies and medical institutions at all levels to monitor the
   sentinel and the marketing license holders to carry out priority monitoring work, and
   formulate the guiding principles in accordance with the “Administrative Measures for
   Monitoring and Reassessing Medical Device Adverse Events”.
   The priority monitoring of medical device adverse events (hereinafter referred to as
   priority monitoring) refers to the staged monitoring activities initiated to study the
   risk status, characteristics, severity and occurance rate of a certain medical device
   variety or product after listing.
2. Job Responsibilities
   2.1 The National Medical Products Administration(NMPA/CFDA) is responsible for the
   priority monitoring work, and selects priority monitoring varieties or products in
   conjunction with the national health administrative department.
   The provincial drug monitoring and administration department (hereinafter referred
   to as the regulatory agency) may carry out priority monitoring work for medical
   devices registered or filed in its administrative area according to the the work needs.
   Relevant works such as the selection of varieties or products may refer to the
   relevant provisions of the State Drug Administration. Implementation.
   2.2 The National Medical Device Adverse Event Monitoring Agency (hereinafter
   Device Adverse Events
   (Draft)
   Guideline on Focus Points When Monitoring Medical
   referred to as the Monitoring Agency) is responsible for organizing and implementing
   the priority monitoring work carried out by the National Medical Products
   Administration(NMPA/CFDA) and coordinating the work of provincial monitoring
   agencies.
   The provincial monitoring agency is responsible for the specific implementation of
   the priority monitoring work organized by the NMPA and the provincial regulatory
   agencies, and coordinateing the work related to its priority monitoring.
   2.3 The medical device marketing license holders (hereinafter referred to as holders)
   that focus on monitoring varieties or products shall actively participate in the priority
   monitoring work,and formulate priority monitoring implementation plans in
   accordance with the priority monitoring work plan formulated by the regulatory
   agencies. Actively collect related risk information such as case report, and write risk
   analysis and evaluation reports on them.
   2.4 The medical device operating units shall actively cooperate with the
   establishment of monitoring sentinels, actively collect relevant data such as priority
   monitoring varieties or product adverse event reports. Cooperate with regulatory
   agencies and monitoring agencies to carry out investigations, analysis and
   evaluation of case report.
3. Work Procedures
   3.1 Selection of Varieties
   3.1.1 The priority monitoring activities carried out by the regulatory agencies at or
   above the provincial level shall be selected with the health administrative
   departments at the same level to select priority monitoring varieties. The priority
   monitoring varieties should be determined according to the registration of medical
   devices, adverse event monitorings, monitorings and inspections, inspection status,
   product risk levels and usage conditions.
   3.1.2 Innovative medical device products are automatically included in priority
   monitoring activities.
   3.2 Planning
   3.2.1 The NMPA is responsible for formulating priority monitoring work plans carried
   out by the national authorities, and the provincial regulatory agency is responsible
   for formulating corresponding implementation plans for priority monitoring work.
   3.2.2 The holders of priority monitoring varieties or products shall, in accordance
   with the requirements of the priority monitoring work plan, formulate the priority
   monitoring implementation plan for the holders, and report to the provincial-level
   regulatory agencies that undertake the review and filing for priority monitoring
   varieties. The implementation plan of the holder’s priority monitoring should include
   the organization ways, schedule arrangements, and work procedures.
   3.3 Implementation
   3.3.1 Establish monitoring sentinel
   Provincial regulatory agencies shall set up monitoring sentinels at the level II medical
   institutions and above. Establish no less than 10 monitoring sentinels in principle,
   and establish a monitoring sentinel management system. Holders participating in
   priority monitoring can use their product user units as monitoring sentinels
   according to their own situations, and actively collect risk information such as case
   report.
   3.3.2 Investigation
   Provincial monitoring agencies and holders are required to investigate adverse events
   for death or serious injury, including adverse event performance, product use
   situations, event handling, etc.