Decree 1 Measures For The Administration Of Medical Device Adverse Event Monitoring And Re-evaluation

Order of the State Administration for Market Regulation and the
National Health Commission of the People’s Republic of China (No. 1)
The Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation, as
deliberated and adopted by the State Administration for Market Regulation and the National Health
Commission, are hereby issued and shall come into force on January 1, 2019.
Director of the State Administration for Market Regulation: Zhang Mao
Director of the National Health Commission: Ma Xiaowei
August 13, 2018
Measures for the Administration of Medical Device Adverse
Event Monitoring and Re-evaluation
Chapter I General Provisions
Article 1 For the purposes of strengthening the adverse event monitoring and re-evaluation of medical
devices, promptly and effectively controlling the post-market risk of medical devices, and protecting the
health and safety of people, these Measures are developed in accordance with the Regulation on the
Supervision and Administration of Medical Devices.
Article 2 These Measures shall apply to the adverse event monitoring, re-evaluation, and supervision
and administration of medical devices conducted in the territory of the People’s Republic of China.
Article 3 A medical device marketing licensee (hereinafter referred to as the “licensee”) shall have
quality management capabilities for ensuring the safety and effect of medical devices and corresponding
responsibility assumption capabilities and establish a medical device adverse event monitoring system
to directly report medical device adverse events to medical device adverse event monitoring technical
agencies (hereinafter referred to as the “monitoring agencies”). Operation enterprises authorized by
licensees to sell and medical device user entities shall report medical device adverse events to the
licensees and monitoring agencies.
A licensee shall evaluate discovered adverse events, improve product quality according to the evaluation
results, and report on the evaluation results and quality improvement measures to the monitoring
agency; and if approval of the original registration authority is necessary, an application shall be
submitted as required.
The agent designated by an overseas licensee shall assume the adverse event monitoring work relating
to imported medical devices sold in China and cooperate with the overseas licensee to perform the reevaluation obligation.
Article 4 Definitions of the following terms in these Measures:
(1) “Medical device marketing licensee” means a holder of a medical device registration certificate and a
medical device filing certificate, to wit: the medical device registrant and filing person.
(2) “Medical device adverse event” means a harmful event which occurs when a marketed medical
device is in normal use and results in or may result in physical harm to human.
(3) “Serious impairment” means one under any of the following circumstances:
(a) Life-threatening.
(b) Resulting in permanent impairment of a body function or permanent damage to a body structure.
(c) Requiring medical measures to prevent the aforesaid permanent impairment or damage.
(4) “Group medical device adverse event” means an event that occurs in a relatively specific period of
time or region during the use of the same medical device, causing damage or threat to the personal
health or life safety of a certain number of people.
(5) “Monitoring of medical device adverse events” means the process of collecting, reporting,
investigating, analyzing, evaluating, and controlling medical device adverse events.
(6) “Priority monitoring of medical devices” means phased monitoring activities proactively conducted in
order to study the information, characteristics, severity, and incidence of the post-market risk of a
variety or product.
(7) “Re-evaluation of medical devices” means the process of re-evaluating the safety and effectiveness
of registered or filed marketed medical devices and taking corresponding measures.
Article 5 The State Drug Administration shall establish a national medical device adverse event
monitoring information system and strengthen the development of the medical device adverse event
monitoring information network and database.
The monitoring agency designated by the State Drug Administration (hereinafter referred to as the
“national monitoring agency”) shall be responsible for the unified management of the collected
information on medical device adverse events and give relevant monitoring agencies, licensees,
operation enterprises, or user entities feedback on medical device adverse events.
Monitoring information related to product use risk shall be communicated to the health authorities.
Article 6 The drug supervision and administration authorities of provinces, autonomous regions and
municipalities directly under the Central Government shall establish a medical device adverse event
monitoring system, improve relevant systems, and assign corresponding monitoring agencies and
personnel, to monitor medical device adverse events.
Article 7 Any entity or individual shall have the right to report on a medical device adverse event
discovered to the authority in charge of drug supervision and administration (hereinafter referred to as
the “drug authority”) or the monitoring agency.
Chapter II Duties and Obligations
Article 8 The State Drug Administration shall be responsible for the supervision and administration of
adverse event monitoring and re-evaluation of medical devices nationwide, organize and conduct the
investigation and disposition of group medical device adverse events which have a relatively significant
impact nationwide and cause serious impairment or death or other serious consequences in conjunction
with the health department of the State Council, and take emergency control measures according to the
law.