TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
Posts published in “Australia”
Interesting framework to evaluate the performance of regulators – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018. Framework interessante para avaliar o desempenho deTGA…
Another hot topic, together with Cybersecurity, is SaMD (Software as a Medical Device). Updated information from TGA here – Regulation of Software as a Medical Device.…