To achieve the objective of protecting health and safety of patients, users and others in clinical trials, safety issues associated with medical devices should be identified as soon as possible.
These issues can then be addressed through modifications of medical device or clinical trial protocol, revision of the instructions for use, or withdrawal of the device from use.
Refer to GN-05 Guidance on Reporting of Adverse Events for Medical Devices357 KB for full details on adverse events reporting requirements.
What to report
As a general principle, you should be pre-disposed to report a medical device adverse event (AE). Any AE that meets the criteria listed below is considered reportable:
- An AE (or potential AE) has occurred.
- The device product is associated with the AE.
- The AE led to one of the following outcomes:
- A serious threat to public health.
- 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 of a patient, user or other person if the event recurs.
- Death of a patient, user or other person.
When to report
The following AEs must be reported to us within the indicated timelines:
| Types of AEs
|| Report within
| Serious threat to public health
|| 48 hours
| Results in death or serious deterioration in the state of health, of a patient, a user of the medical device or any other person
|| 10 days
| May result in death or serious deterioration in the state of health, of a patient, a user of the medical device or any other person, if the AE were to recur
|| 30 days
Include as much relevant detail in the initial report as is immediately available, and do not delay the report for the sake of gathering additional information.
The sponsor of the medical device clinical trial should follow up with a final report within 30 days of the initial report, detailing the investigation into the AE. Follow up reports may be requested as and when necessary.
How to report
It is mandatory for local sponsors and medical device companies (including product registrants, manufacturers, importers and suppliers) to report any AEs related to the medical devices they deal in.
Please complete the Medical Device Adverse Event Report Form for Clinical Trials174 KB and submit to us via e-mail with the subject as "Medical Device AE Reporting for Clinical Trials".