CFDA recently organized a 3-day training session on In Vitro Diagnostics Clinical Evaluation and Trials in Beijing. Around 200 industry professionals participated in the event. Representatives from Brandwood Biomedical Beijing joined this session. Key discussions include: Review on In Vitro Diagnostics regulations Requirements on In Vitro Diagnostics Clinical Evaluation Overview of In Vitro Diagnostics Clinical […]
Archives for April 2018
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 […]
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 is proceeding to update its Advertising regulations. The next step is a public consultation ending 27 April 2018. We look at the specific changes and their impact.