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Submission to the TGA on the Potential for Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia


Last updated 17 December 2021

Summary

Date: 16 December 2021

The RACGP has provided a response to the TGA on the Potential for Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia. The response supports adverse event reporting but highlights that existing barriers need to be addressed before reporting is made mandatory. Structured voluntary reporting is recommended by the RACGP until issues as a result of, or due to reporting of such events have been addressed. Feedback on the platform for reporting, responsibilities for reporting and barriers to reporting are addressed in the response.

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