Medical device dealers should report the Field Safety Corrective Action via the Online Safety, Compliance Application and Registration (OSCAR) System.
For companies new to the OSCAR system, the company’s Corppass Administrator will first be required to log in to the platform. After which, the company’s profile will be automatically created and the Corppass Administrator will be assigned with the OSCAR Administrator role. The OSCAR Administrator can then create OSCAR User/Administrator accounts for other company users. Please refer to the Quick Guide for Admin and User Account Creation for a step-by-step guide to create new OSCAR user accounts. CorpPass account is required to access OSCAR for all users.
Please click here to access the OSCAR system.
For assistance on how to submit the FSCA report online, you may refer to the OSCAR User Manual and the following quick guides:
Dealers who encounter errors while submitting FSCA reports through OSCAR may contact HSA via email, with details of problem encountered, description of steps taken prior to generation of error, and screenshots of OSCAR system error message.
If the situation calls for it, HSA may advise the manual submission of MDRR1, MDRR2 & MDRR3 forms to HSA via email.
Types of FSCA reporting:
- For affected devices manufactured, or supplied in Singapore, a Notification Report (MDRR1) should be submitted to HSA via OSCAR before the initiation of FSCA or stock recovering in Singapore. Some information (e.g. distribution chains and batch size) may not be available immediately, but do not delay in notifying HSA with the available information.
- For affected medical devices that are registered, listed in Class A database or have special access route (SAR) clearance but have not yet been supplied in Singapore, a MDRR3 FSCA reporting should be performed via OSCAR within 30 days of initiating the FSCA in any country globally.
Attachments to FSCA Notification Acknowledgement Notice (MDRR1)
Once a FSCA Notification report (MDRR1) has been submitted and received by HSA, an acknowledgement will be issued to the reporting person. In the acknowledgement, it will indicate the attachment that the reporter shall refer and comply with for the FSCA. Please click the following files to view the standard measures stipulated in the relevant attachment to MDRR1: