Australia’s TGA releases updated Essential Principles Checklist
In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles define the requirements for the...
Hitting the Accelerator
The Therapeutic Goods Administration’s (TGA) priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines. The priority review pathway is suitable for products with a...
DOC’s will need to be submitted for new Class I IVD ARTG registrations
Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email to stakeholders on 17 November...
TGA will require DOC’s to be submitted for Class I ARTG registrations
Australia’s, Therapeutic Goods Administration (TGA) issued a notice on 1 October 2020, in addition to an email to stakeholders prior, specifying new policies for the inclusion of non-sterile, non-measuring Class...
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...