Singapore Health Sciences Authority (HSA) shared the following updates on 28 March 2019:
Update to the GN21 Change Notification (CN) Guidance documents
Main updates to GN-21 Annex 1 Change Notification Submission requirements and
clarification on CN document requirements were made on product changes related to:
-Software -Biological Materials -Addition of models
New revision GN-21 R4.5 will be released in first week of April 2019.
Launch of OSCAR (Online Safety Compliance Application & Registration System)
HSA launched the online FSCA reporting system, with the following objectives:
Allow better tracking of company's past FSCA report submissions. Easily filter for cases that are still open and require your follow up.
Digitises the current reporting process. HSA's aim is to make FSCA submission process intuitive and easy to use where OSCAR becomes a one stop platform for everything related to FSCA.
Streamlines HSA internal FSCA processing which allows the FSCA report to be reviewed and cleared more efficiently.
Ultimately, at the core of HSA mission is to safe guard public health, the faster processing will ensure recall and device correction are initiate in a more efficient and timely manner so as to not compromise patient safety in Singapore.
Soft launch of OSCAR will be in June 2019 with a transition period of 3 months and full implementation in September 2019.
Video guide of the system will be available in June 2019 on HSA Field Safety Corrective Action page.
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