This week Australia’s TGA issued letters to multiple sponsors calling in technical data on custom surgical implants. The agency is taking a closer look at the evidence held by manufacturers for safety and performance of custom devices. This will inform TGA’s planned reforms for regulation of advanced manufactured devices. In the short term, those without adequate data may be in for an uncomfortable time.
There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR). We take a look at the lessons to learn from the Australian experience.
The Australian Senate Community Affairs Committee has recommended that parliament pass amendments to the Therapeutic Goods Act to implement reforms arising from the Sansom review.
The amendments pave the way for some key changes including introduction of Australian Conformity Assessment Bodies
Last week, the Australian Therapeutic Goods Administration (TGA) published the final guidelines on Clinical Evidence for devices. The guidelines reiterate key elements of clinical evaluation that are often missing from Clinical Evidence Reports. The guidelines also provide specific requirements for certain high risk devices.
TGA has recently released its five new Declaration of Conformity templates specifically for IVDs. In this article we outline which template should be used depending on the conformity assessment route taken and the classification of the IVD.
Innovative Pathways for fast track approval of new technologies are continually in the news. These pathways attempt to serve industry development goals in the guise of meeting unmet clinical needs. Still it’s a laudable goal. But are these programmes effective? or safe?