Singapore HSA Adjust Medical Device Field Safety Notice (FSN) Requirements
EMERGO SUMMARY OF KEY POINTS:
- Singaporean hospital directors and managers must now be copied on field safety notices (FSNs) sent from medical device registrants.
- The new FSN requirement came into force in early March 2017.
Singapore’s medical device market regulator now requires registrants issuing field safety notices (FSNs) regarding their products to copy managers of affected local healthcare facilities.
Emergo consultants in Singapore report that the Health Sciences Authority’s (HSA) new rule went effective March 8, 2017. Registrants whose medical devices require FSNs due to adverse events or public health issues must now send FSNs not only to regulators and end users, but also to medical board chairpersons and department heads of all affected local hospitals. FSNs are required as part of the HSA’s larger Field Safety Corrective Action (FSCA) rules.
The rule is intended to make hospital managers aware more quickly of any health issues related to devices used in their facilities, and also to allow facilities to implement follow-up corrective actions to mitigate or prevent safety issues.
Singapore registrants must first report any FSCA information to the HSA before issuing FSNs to end users.