Annex 7
- 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. - 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. - 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.
