Annex 5
Collection and Reporting of Medical Device Adverse Events for
Marketing Authorization Holder Guiding Principles
(Draft)
- Purposes
For the purpose of regulating the collection and reporting of medical device adverse
events for medical device marketing authorization holders, these measures are
developed in accordance with the “Administrative Measures for Monitoring and
Reassessing Adverse Events of Medical Devices” (State Administration for Market
Regulation, Order No.1) - Collection of adverse events
Isolated medical device adverse events refer to death and serious injury events
involving a single patient or operator that may be associated with a medical device,
hereinafter referred to as “adverse events.” The case report of medical device adverse
events refers to the process in which the marketing authorization holder fills in the
information related to the medical device adverse events and reports through the
National Medical Device Adverse Event Monitoring Information System, hereinafter
referred to as the “Case Report”. Marketing authorization holders should establish a
collection of adverse event information for medical device operators, users (medical
institutions) and patients, actively collect academic literature, post-marketing adverse
events, and expand information collection on the Internet, digital media, and social
platforms.
2.1 Distributor
The marketing authorization holder should actively collect information on adverse
events from medical device operators and ensure that the business is aware of effective
ways to report adverse events to them. The marketing authorization holder shall clarify
the responsibility for reporting the adverse events of the enterprise in the form of signing
the entrustment contract and train the relevant personnel of the operating enterprise to
understand the objectives, methods, contents and storage requirements of the
collection of adverse event information. Marketing authorization holders should
regularly assess the ability of operating companies to fulfill their information collection
responsibilities and take necessary measures to ensure the quality of information
collection.
2.2 Device operating unit (Medical institutions)
The marketing authorization holder shall designate personnel to collect information on
adverse events occurring in the device operating unit through daily visits to
maintenance personnel, or by e-mail or fax. The above communication should be
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carried out regularly, accurately recorded and saved. When the marketing
authorization holder or his distributor signs a medical device purchase and sale
contract with the user, the user should be fully informed the holder’s responsibility for
reporting adverse events, the user should be encouraged to report adverse events to
them, and the marketing authorization holder should jointly develop plan for collecting
information on adverse events in the device operating unit.
2.3 patients
The contact number published by the marketing authorization holder in the medical
device manual and label is an important way for the patient to report an adverse
event, make a complaint or consult, and the phone should be kept open. The
marketing authorization holder is encouraged to set up a special adverse event report
phone (such as 400 hotline). The marketing authorization holder should inform the
public of the call and its function in an effective manner. If the phone number is
changed, it should be updated in the manual and label. The marketing authorization
holder shall designate a person to answer the phone and collect information on
adverse events reported by the patient or other individuals (such as doctors, users,
lawyers).
2.4 Academic literature
The scientific or medical literature is also one of the sources of adverse event
information, and the marketing authorization holder should report adverse events
found in the literature search. The marketing authorization holder shall establish a
literature search specification or procedure to regulate the frequency of search, time
range, source of the literature, type of document, and search strategy. Marketing
authorization holders should systematically review the widely used literature search
database. Common domestic databases include China Knowledge Network, Weipu
Network, Wanfang Database, etc. Foreign databases include PubMed, Embase, Ovid,
etc. The types of literature related to adverse events include: case reports, case series,
review of adverse events, etc. In addition, clinical efficacy and safety studies, metaanalysis, etc. may also contain information on adverse events. The marketing
authorization holder should develop a reasonable search strategy to ensure the
comprehensiveness and accuracy of the search results, and the time range of the
search should be continuous. For first-in-market devices, innovative devices and highrisk devices, marketing authorization holders should increase the frequency of
searches enlarge the range of database retrieved.
2.5 Post-marketing studies
Post-marketing studies or projects initiated by marketing authorization holders
include: post-marketing studies with the primary purpose of understanding the safety
and efficacy of medical devices, and patient –supporting programs, market research,
and patient education activities with marketing as the primary purpose. Adverse
events found in these activities should be collected and reported as required. Both the
marketing authorization holder and the contract research unit can report adverse
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events, in order to avoid duplicate report, license holders and the research unit should
clearly report the subject in the relevant agreement. In principle, the subject of
reporting is the marketing authorization holder, but the marketing authorization
holder must not interfere with the reporting behavior of the research unit (for any
reason).
2.6 Other ways
In addition to the above, the marketing authorization holders also need to collect
reports on adverse events discovered or known through other means, such as the
Internet and related channels. Marketing authorization holders should collect
information on adverse events on the websites they initiate or fund. For adverse
events known from other websites, the marketing authorization holder should
consider whether to report as appropriate. Marketing authorization holders should use
the company’s website to collect information on adverse events, such as creating a
dedicated path for reporting adverse events on the website, providing methods for
reporting, forms of reporting, and guidance of reporting. The print media, digital
media, social media/platforms initiated or hosted by the holders, such as corporate
public WeChat accounts, Weibo, forums, case sharing meetings, etc., are also sources
for collecting information on adverse events. - Processing of adverse events
In order to ensure the collection, transmission, accuracy and traceability of reporting
adverse events, the marketing authorization holder shall establish and maintain a
record of the collection and reporting of adverse event information and verify and
confirm the adverse events.
3.1 Record
For directly discovered adverse events, the marketing authorization holder should fully
obtain relevant information, including the occurrence of adverse events, the use of the
device, the patient’s condition, the suspected and combined use of the drug, etc. If
there exists difficulty, the marketing authorization holder should try to obtain more
important information for risk assessment. For adverse events indirectly through
email, letter, telephone, doctor interview, etc., the marketing authorization holder
shall make the original record, and the recorded content shall include the date of the
record, the rapporteur, and providers for other information, in addition to the adverse
event information. The original record can be a paper record, or it can be an electronic
document, a recording, or a screenshot of a website. For adverse events known in the
literature search, the date of retrieval, personnel, search strategy, etc. should be
recorded, and the original documents obtained by the search should be saved. If the
relevant information is not retrieved, it should be recorded. Records should be
truthful, accurate, objective and well preserved. The marketing authorization holder
shall number the adverse event records and the number shall be continuous and may
be traced back to the record according to the number.
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3.2 Transmission
The marketing authorization holder should specify the time limit for the delivery of
adverse events to ensure the timeliness of the report are met. Record information
should be kept authentic and complete in the relevant departments and personnel
delivery. All missing information and changes to the original data should be noted.
3.3 Verification
The marketing authorization holder shall review the authenticity and accuracy of the
adverse event information and, if in doubt, verify the relevant information. If the
adverse event comes from a cooperative unit other than the holder, such as a business
enterprise, a device operating unit, a literature search institution, a research
cooperation unit, etc., there should be binding provisions in the agreement between
the parties to ensure that the information collected by the partner is true and
accurate. It is the responsibility of the marketing authorization holder to check or
review the information on adverse events provided by the partner and to be
responsible for the quality of adverse event reports submitted to the regulatory
authorities.
