Since October 2014, when the Chinese Food and Drug Administration (CFDA) announced new regulations requiring medical device manufacturers to conduct more local clinical trials to obtain Class II and Class III approvals, the timeframe and cost to register products has grown exponentially.
At the same time, the regulations allow some Class II and III devices to forego local clinical studies if the foreign device manufacturer submits a convincing Clinical Evaluation Report (CER). The CFDA offers a training course on submitting a CER.
To effectively generate a CER, foreign manufacturers need access to relevant databases to obtain supporting documentation and then perform statistical analyses on their research. The trouble is that several of these databases may be blocked by firewall controls in China while others, such as Cochrane and Medion, can be very expensive. To find the right information, a capable literature search expert is needed.
While the CER guidance is almost a copy of the CE guidance, the CFDA is not clear on what the CER should contain. It is also unclear how China’s Center For Medical Device Evaluation (CMDE) plans to assess CERs, as their reviewers likely do no have the appropriate training. Many device manufacturers are waiting to see how the CMDE will review CERs in the hopes that the CERs will be acceptable and the CFDA will not require as many foreign device manufacturers to conduct local clinical studies.