Australian Regulator Prepares for the Brexit Fallout
Following our earlier article Fog in the Channel: a European Medtech Perspective on Brexit where we outlined the need for the EU and UK to manage the pending fallout of...
The commercialization continuum: beyond product registrations
Your product is approved, now what? This is a question that can bring a painful realization to medical technology manufacturers and suppliers eagerly entering a new market. The appropriate preparation...
TGA Introduces Patient Implant Cards…and the dates are approaching fast!
In October 2017, the Australian government approved regulations introducing requirements for manufacturers to provide consumer information with all new permanently implantable devices (other than those exempted) supplied in Australia. As...