Brandwood Biomedical has been working in Taiwan for several years, including supporting a number of clients in navigating the regulations and post-market requirements. With an increasing population of 23.5 million and a Medical Device market of US $4.7 billion reported in 2016, it’s not surprising that companies are still very interested in entering this lucrative […]
As we watch the changes in Europe evolve under the Medical Devices Regulations (MDR), we are starting to see an increasing trend where companies that had previously used Europe as a fast pass into Australia, starting to go directly to Therapeutic Goods Administration (TGA) for their conformity assessment. Earlier times saw the regulator struggling with […]
At the March 2018 Shanghai meeting of IMDRF, new work item proposals from China on GCP practices and the update of technical standards were approved. These seemingly routine administrative efforts mask a radical change – with China for the first time taking the lead on IMDRF harmonization efforts and seeking to promulgate its own approaches into global regulation. We take a look at what’s really going on.
Over the past few months, I’ve had numerous conversations with US Manufacturers, Regulators and others about CFDA’s Innovative Device Pathway. And it’s clear there’s a real misunderstanding about the actual benefits and challenges this Pathway brings. In this article, I try to make it a little clearer on what leads to a successful application and […]
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… […]