Singapore Regulators Make Medical Device FSCAs Publically Available
The Health Science Authority (HSA), Singapore’s medical device market regulator, will begin publishing field safety corrective action (FSCA) information on its website to boost public awareness of risk and safety issues involving devices legally sold in the country.
The new FSCA policy will apply both to new incidents and retroactively to those occurring between January and August 2015. Field safety notice information published by the HSA will include device name, company name and contact details for local representatives.
Only field safety notices filed by local representatives such as Singapore Authorized Representatives with the HSA will be made publically available, according to an analysis of the new policy by Emergo consultants in Singapore.
The HSA's new field safety notice publication policy brings Singapore regulations in line with those of other major medical device regulatory agencies that have implemented similar processes for public access to FSCA data.