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 […]
China’s 13th National People’s Congress approved a merger of a host of current regulatory agencies – including CFDA, into a new super-ministry for all things regulatory. We take a look at the powers of the new SMRA – or the State Market Regulatory Administration and ask what it means for CFDA’s devices reforms.
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.
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.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?