HSA Singapore medical device postmarket surveillance and vigilance
Mandatory adverse event (AE) or vigilance reporting is an essential part of your post-market surveillance system in Singapore.
Overview of Singapore vigilance reporting for medical devices
Mandatory adverse event (AE) or vigilance reporting is an essential part of your post-market surveillance system in Singapore. AE reporting is intended to protect the health and safety of users and patients and prevent the recurrence of the adverse events. The Health Science Authority (HSA) requires manufacturers, importers, suppliers, and registrants to report adverse events involving their medical device. You must have adequate systems in place to investigate, review, and report AE’s to the HSA within the required timelines and quickly implement any field safety corrective actions (FSCAs).
Once an adverse event has been reported, you must follow up with a final report on your investigation within 30 days of the initial report. The final report should cover conclusions about the root cause of the event and any corrective and preventive actions (CAPAs) you plan to execute. If the adverse event is severe and likely to recur despite corrective actions, a recall or withdrawal from the Singapore market may be necessary.
What types of medical device adverse events should be reported in Singapore
According to HSA’s guidance on adverse event reporting, any event that occurs and is associated with your device should be reported if the event led to one of these outcomes:
- a serious threat to public health;
- death of a patient, user or other person;
- serious deterioration in state of health of the user, patient, 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.
Reporting should be the default approach to an adverse event occurrence.
When to report a medical device adverse event in Singapore
Adverse events should be reported to HSA within the following timelines:
- Within 48 hours: serious threat to public health.
- Within 10 calendar days: 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.
- Within 30 days: 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.
These timelines begin as soon as you become aware of the adverse event. It’s important to adhere to the reporting timelines, even if you feel insufficient information about the event is available or you doubt the event is reportable.
Frequently
Asked Questions
What is considered an adverse event for an IVD medical device?
IVDs don’t always come into contact with the patient, so it can be more challenging to directly link an IVD to an adverse event. However, examples of IVD adverse events include:
- Misdiagnosis;
- delayed diagnosis;
- delayed treatment;
- inappropriate treatment.
Do I need to report an adverse event that occurred outside of Singapore?
According to HSA guidance on adverse event reporting, adverse events that occur outside of Singapore do not need to be reported unless this is a condition specified in your HSA device registration or HSA issues a notice requesting adverse event information about your device.
What is a corrective and preventive action (CAPA)?
HSA’s guidance on Field Safety Corrective Actions (FSCAs) defines CAPAs as “actions taken to address the identified root cause for the device problem or issue.” An FSCA is “any action taken to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device.”
