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Field Safety Corrective Action reporting

  1. How to report

How to report

 

Medical device dealers should report the Field Safety Corrective Action via the newly launched 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.

Please click here to access the OSCAR system.

For assistance on how to submit the FSCA report online, you may refer to the OSCAR Submission E-Guide, which provides a comprehensive step-by-step guide. Please click here to view the E-Guide.

Alternatively, you may refer to the OSCAR User Manual and the following quick guides:

Types of FSCA reporting:

  • For affected devices manufactured, or supplied in Singapore, a Notification Report (MDRR1) should be submitted to HSA via OSCAR. 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. After initiating the FSCA, submit a Final Report (MDRR2 form) within 21 days. If the FSCA has not been completed, submit a follow-up report at the 21st day mark.
  • For affected medical devices that are registered 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:

Transitional Period before full implementation of OSCAR

The OSCAR system has officially launched on 6 January 2020 where Medical Device Dealers can begin submitting FSCA reports to HSA via the online platform.

 

Launch timeline - 6 Jan 2020

A transitional period of 3 months (6 January 2020 to 5 April 2020) will be provided to all dealers. During this period, dealers may continue to submit their FSCA reports (MDRR1, MDRR2 & MDRR3 forms) to HSA via email. However, stakeholders are encouraged to use the new OSCAR platform to familiarise with the submission system before full implementation on 6 April 2020 after which HSA will only accept online FSCA report submission via OSCAR. 

 

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