TGA Updates Guidance on IVD Self-Tests for Chlamydia, Gonorrhoea and Syphilis
The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.
Swissmedic Updates Information Sheet on Clinical Investigations of Medical Devices
Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.