In-house IVDs – TGA Release New Guidance
The TGA have published a guidance document for manufacturers of in-house IVDs (in-vitro diagnostic device) to assist in ensuring compliance with the new regulatory framework, relea
What Does Recall Really Mean? The GHTF Aim to Provide Clarity
The recent PIP breast implant saga is a reminder of just how important it is for us, the medical device industry, to have a universal system for identifying, classifying and resolv
Export Corporation Penalised $3.1 Million for Illegal Supply
On the 3rd of February 2012 the Federal Court ruled that Export Corporation (Australia) Pty Ltd should pay civil penalties of just over $3.1 million for importing and supplying a n
Changes Afoot for Medical Device Manufacturers in Argentina, Brazil, Colombia and Cuba
The agencies which regulate medical devices in Argentina, Brazil, Colombia and Cuba have initiated plans to work together to recognise certification of medical device manufacturers
