TGA acceptance & Health Canada License
TGA (Australia) has accepted the clinical evidence for SCENAR devices and the post-market review has completed successfully! The Therapeutic Goods Administration (TGA) is Australia's regulatory agency for medical drugs and devices. Everything is in compliance with TGA now and we (Ritm Australia and Oceania) can confidently continue to expand the use of Ritmscenar devices in Australia. Thanks to the great effort of Ritm Australia and Oceania.
Ritm OKB was granted the Health Canada Device License on the 18th May 2011. The Medical Device License has been issued without terms or conditions other than complying with those terms and conditions in the application. Thanks to the cooperation of Ritm Canada and Ritm OKB.