Post Market Vigilance and

FSCAs
Singapore, HSA
• HSA requires medical device manufacturers to comply
with a vigilance system for post-market monitoring and
adverse event reporting.
• Manufacturer or the Registrant are obliged by law to
report an adverse event in Singapore if a medical device
has contributed to one of these outcomes:
• serious threat to public health
• death of a patient, user or other person
• serious deterioration in state of health of patient, user or
other person
• no death or serious injury occurred, but the event might lead
to death or serious injury if it recurs
Reporting of Adverse Events for Medical Devices
• Any AE, which meets the three basic reporting criteria listed
below, is considered as a reportable AE:
• an AE has occurred;
• the medical device is associated with the AE;
• the AE led to one of the following outcomes;
• a serious threat to public health;
• death of a patient, user or other person;
• serious deterioration in state of health, user or other person;
• no death or serious injury occurred but the event might lead to
death or;
• serious injury of a patient, user or other person if the event recurs.
AE for Medical Devices Reporting Timeline
• All AEs should be reported immediately and
• not later than 48 hours for events that represents a serious
threat to public health;
• not later than 10 days for events that has led to the death, or
a serious deterioration in the state of health, of a patient, a
user of the medical device or any other person;
• not later than 30 days for events where a recurrence of which
might lead to the death, or a serious deterioration in the state
of health, of a patient, a user of the medical device or any
other person.
• If there is uncertainty about whether the AE is reportable, dealers
should still submit a report within the timeframe stipulated.
AE for Medical Devices Reporting Mode
• All reports shall be submitted in the following form and manner:
• Form# MDAR1 for reporting of adverse events not related to clinical trial
• Form# CTB_MD_AE for reporting of adverse events related to clinical trial
• Either the PDF or MS word version is to be submitted, not both. The
completed form may be submitted via email to
hsa_medical_device@hsa.gov.sg .

For more detailed information, please refer to HSA Guidance Document GN-
05-R2_ Guidance on The Reporting of Adverse Events for Medical Devices
Field Safety Corrective Action (FSCA) (including
Recalls) Reporting Timeline
• Field safety corrective actions (FSCAs), such as recalls, must be
reported to the HSA at least 24 hours before initiating the FSCA.
• A preliminary report with thorough information about the FSCA
should also be submitted within 24 hours.
• A recall notice detailing the hazards associated with the medical
device and corrective actions taken should be distributed to
consumers.
• A final recall report must be submitted to the HSA within 21
days.
FSCA – Recall Strategy
• Recall strategy (detailed plan) is expected to address the
following elements, regarding the conduct of the recall:
Depth of Recall
Recall Communication
Effectiveness Checks
Stock Control

*For detailed information on these, please refer to the HSA Guidance Document GN-
04-R2 _ Guidance on Medical Device Recall
FSCA – Elements of A Recall SOP

To be notified and submit a preliminary

report with thorough information about the
recall to HSA at least 24 hours before the
recall

Submit a full detailed report on the recall

within 21 days after the procedure