Singapore Launch of OSCAR System for FSCA Reporting
As part of HSA’s on-going effort to improve efficiency in our processes, HSA is pleased to announce the upcoming soft launch of the Online Safety Compliance Application and reporting (OSCAR) system for Field Safety Corrective Action (FSCA) Reporting.
With effect from 6th January 2020, medical device dealers are able to report their FSCA to HSA via the new online platform. The FSCA OSCAR platform web link will be available on our website at https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report from 6 January 2020. There will be a transitional period of 3 months (6th January 2020 to 5th April 2020) during which dealers may continue to submit their FSCA reports (MDRR1, MDRR2 & MDRR3 forms) to HSA via email (hsa_medical_device@hsa.gov.sg). However, stakeholders are encouraged to use the new OSCAR platform to familiarise with the submission system before full implementation on 6th April 2020 as from this date, the online system will replace the email reporting option.
Please refer to the attached Quick Guide for Admin and User Account Creation. This guide provides step-by-step instruction for the company’s CorpPass Administrator to create new OSCAR user accounts before company users are able to access OSCAR. Please also refer to the OSCAR User Manual and Quick Guides attached above for instructions on navigating the platform. These guides can also be accessed on their website https://www.hsa.gov.sg/medical-devices/field-safety-corrective-action/how-to-report from 6 January 2020.
Source: Health Sciences Authority (HSA).