The structure of the Regulatory Services Group, key facts and figures, international collaboration and the evolving state of medical device regulation were key topics at the TGA’s recent Device Sponsor Information Day, supported by AusBiotech.
Presented by Professor John Skerritt, Deputy Secretary, Regulatory Services Group, Department of Health (TGA), the Information Day was held in Canberra on 15 October 2015. Professor Skerritt’s introduction can be found at the TGA website.
Presentations covered numerous aspects of Australian devices regulation. The entire Day’s slide sets are now available and at the TGA website.
Presentations were made by the TGA and industry experts, such as Brandwood Biomedical and included topics such as pre and post-market monitoring, conformity assessment, use of CE certificates to gain Australian approvals, adverse event reporting, clinical evidence, recalls and advertising.