Medical devices marketed and distributed in Singapore have long been subject to strict requirements that mandate any safety hazards associated with their use be reported to government authorities. Now a new online system makes reporting of what is known in Singapore as Field Safety Corrective Action (FSCA) simpler and easier. The Online Safety Compliance Application and Reporting (OSCAR) system shifts reporting of such hazards into an online format.
Effective April 6, Singapore’s Health Science Authority, which regulates the safety and efficacy of medical devices, requires submission of FSCA reports using the new online system.