The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devices with well established safety...
The European Commission has finally issued it’s much awaited draft regulation on e-labelling, the final version of which is expected to be adopted by 14 December and come into force...
The TGA proposed regulatory reforms during October 2010 in response to the Australian Government Health Technology Assessment Review (HTA) and after considerable consultation further information has been released. The announced...
The FDA has issued a new guidance to manufacturers detailing when to submit a new 510(k) for changes or modifications made to that manufacturer’s previously cleared medical device. This guidance...
Positive news for therapeutic goods manufacturers as the Australian and New Zealand Governments agree to resume plans for a joint scheme for regulation of therapeutic goods. The joint scheme will...
The Therapeutic Goods Administration (TGA) local representative (termed sponsor by the TGA) requirements can be a significant road block for non-Australian based manufacturers. KD&A can provide an effective and reliable...
Health Canada has changed its rules and requirements concerning Medical Device Establishment Licensing (MDEL), which provides a regulatory framework for selling or importing medical devices into Canada. Specifically, it serves...
The internet is a vast resource and hunting through available information can be time consuming – making it difficult for you to find what you need, when you need it....
The 4 Corners program on ABC television which aired on the 16th of May explored the failure and subsequent recall of the DePuy Orthopaedics ASR hip replacement device, raising questions...
On 4 May 2011 the TGA is going to launch its new website. A site map and navigation guide have been released by the TGA to assist users, these documents...