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 […]
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.