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 […]
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.
On December 28, CFDA released the draft regulations for inspection of overseas drug and medical device manufacturers. Domestically CFDA has been stepping up inspection efforts for several years, including unannounced and random audits. Now CFDA inspection is going global. We take a look at the proposed inspection program.
So you got your registration. It was hard, but you got there. All that pesky regulatory stuff is done and now you can get on with the real business of selling product. But, of course, it’s not the end of the story. Regulation is whole-of-product-life and postmarket monitoring matters. No more so than in China, where the latest changes in CFDA regulations mean renewals are now all about looking back at the postmarket record. If you haven’t paid attention to postmarket, expect to struggle with registration renewal. We take a look at the latest changes in China and how to be prepared.
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.