HSA launches Singapore OSCAR online FSCA reporting and GN-21 update

March 29, 2019

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.

 

 

Contact us at info@arqon.com.

 

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