There is likely to be a lot of activity in the Private Health Sector in Australia in 2018, particularly in medical devices. Following on from the highly publicised five-year Prostheses agreement between the Commonwealth Department of Health and the Medical Technology Association of Australia, implementation of the agreement must now take place. The agreement included […]
We are delighted to confirm that the forthcoming Asia Pacific Device Summit will feature a presentation by Yongheng Chang of China Food and Drug Administration. Mr Chang will speak on China’s Policies to support Medical Device Innovation including navigating the Innovative Device Pathway for CFDA approval, He will also provide an up to the minute […]
The new European MDR and IVDR require that all devices are re-qualified – no grandfathering here. So how much clinical data is enough for established devices? European guidance is in the works. It’s time to speak to your Notified Body.
As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the requirements for the new Priority review designations For Medical devices (including IVDs). The TGA had discussed the availability of this process as a result of […]
After attending the Medtech Monday event held in Irvine this week, it became very apparent that the thought of managing the regulatory or quality requirements of your product was a scary one for the novice. This had me thinking of key learnings that I’ve found valuable in product development, and thought I’d share a few… […]
TGA’s new recall procedures went live on the 15th of January 2018. The update includes changes to definitions and descriptions –
removing some of the confusing terminology that previously existed. There’s new processes with greater flexibility and clarity – including some new flow charts. We take a look at how to plan for a recall – it happens to everyone sooner or later.