Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update
HSA Safety Monitoring and GDPMDS Guidance Documents Update
On September 08, 2023, the Health Sciences Authority (HSA) of Singapore published updates to related safety guidance documents as well as GDPMDS document, as follows:
• GN-05: Guidance on Reporting of Adverse Events for Medical Devices Revision 3
• GN-07: Guidance on Complaint Handling of Medical Devices Revision 3
• GN-33: Guidance on the Application of Singapore Standard Good Distribution
Practice for Medical Devices Revision 2
The guidance documents are applicable to medical device dealers, namely registrants, manufacturers, importers, and distributors.
In all 3 guidance documents, the HSA reiterates the importance of encouraging feedback from all users such as healthcare professionals, patients, and consumers to institute robust post-market surveillance system for medical device safety.
Specifically, in GN-05 R3:
• A new chapter “Adverse Event (AE) Investigation”, was introduced to provide guidelines on the required information of affected devices to furnish HSA, examples:
– CoA or CoC
– Device history log (events, service reports, manufacturing records) and analysis
– Review of similar local and global complaints, defects and/or AEs
– Justification of remedial actions and CAPAs not taken
• Additionally, dealers are also expected to provide regular updates to HSA while determining root cause, proposed CAPAs (if any), monitor and assess CAPAs’ effectiveness, continued trending analysis (if applicable) and sought approval for risk mitigation measure not taken.
• For acceptable hazards, examples of regulatory actions listed are revising IFUs, providing additional safety communication, providing training/refresher programs for users and/or implementing additional device testing.
For details, please refer to related guidance documents that can be accessed here.
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