The Health Science Authority (HSA) in Singapore launched the new OSCAR system for Field Safety Corrective Action (FSCA) reporting online earlier this year. Previously the HSA accepted the reporting and monitoring of FSCAs via email. However, as of 6 April 2020 companies must use the OSCAR system.
The Health Science Authority (HSA) in Singapore launched the new OSCAR system for Field Safety Corrective Action (FSCA) reporting online earlier this year. Previously the HSA accepted the reporting and monitoring of FSCAs via email. However, as of 6 April 2020 companies must use the OSCAR system. To do so companies require a Corppass Account to access the OSCAR system. Corppass account administrators can create several profiles for company users and grant them relevant accesses. Upon the first login the company details are imported into the OSCAR System making it more convenient to use.
There are two main types of FSCA reporting in Singapore:
- When the affected devices are manufactured or supplied in Singapore. In this case a Notification Report (MDRR1 form) should be submitted to HSA via OSCAR. After initiating the FSCA, a Final Report (MDRR2 form) needs to be submitted within 21 days to the authority. If the FSCA has not been completed, a follow-up report needs to be submitted at the 21st day mark. The content of the forms can be found in the online OSCAR system for easier submission.
- For affected medical devices that are registered via the Special Access Route (SAR) clearance but have not yet been supplied in Singapore. A MDRR3 form to report FSCAs should be performed via OSCAR within 30 days of initiating an FSCA in any country globally.
Companies should not delay a FSCA notification due to incomplete information such as distribution information, batch size etc which understandably takes longer to prepare. Once an FSCA notification report is submitted and received by the HSA, an acknowledgement is issued to the reporting person. In the acknowledgement, the HSA will inform the reporting person on the actions to be taken. The various actions that could be instructed include recall, labelling changes, supply of CIP (correction in progress medical devices) and cease of supply.
The OSCAR system was officially launched on 6th January 2020 so that Medical Device Dealers could begin submitting FSCA reports to HSA via the online platform. All dealers had a transitional period of 3 months (6 January 2020 to 5 April 2020). However, following full implementation on 6 April 2020, the HSA now only accepts online FSCA report submission via OSCAR.