The ACMD stands for the Advisory Committee on Medical Devices, a committee which provides independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on safety,...
Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medical devices. Medtech experts...
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....