They are different from EU CEP. CEP (clinical evaluation plan) is just a planning document which contains the scoping and methodology of clinical evaluation. However, during the design development phase, you have to do the actual clinical evaluation. This is the process you use to determine whether you have sufficient amount of clinical evidence. How should it be documented? This should be documented internally. I don’t think you need to submit this document to the agency.
This question is not very clear. As we mentioned in the presentation, the clinical data can be generated from subject device, equivalent device or comparable device. If you want to use a comparable device as well, you must summarize the clinical data for all devices to compose your CER.
We believe the clinical evaluation is a process. The output of this process serves as the internal documents for you to decide on whether you need additional clinical evidence, whether you need clinical trial for the clinical evaluation and obligation. So, this is the step where you need to collect all existing evidence and try to identify whether you need any additional information.
As of today, we don’t know the answer. But we believe, for periodic updates, this is the process you must follow the new regulation. In our best understanding, you may not need to submit the periodic clinical evaluation report. But in the future, if the agency wants to audit it, you should have these documents already in place. You should have the procedure and documentation in place. But definitely, for the registration of new products or making significant changes to existing products, you need to submit the clinical evaluation report.
As discussed, this is not clarified in the current technical guidance. We believe, however, the updating frequency may be similar to that of EU CERs. This is something we are hypothesizing. Stay tuned for the upcoming final released guidance. It may contain some interpretations or clarifications on this regard.
For the pivotal study, it depends on whether you have conducted studies in overseas. If you have already had it, you may need a small bridging study of 20-50 patients to be conducted in China. If you do not have any overseas clinical data and you want to conduct a pivotal study in China to support a submission for class 3 devices, you may need somewhere around 150 or 200 patients.
Order 739 is the regulation, and all technical guidance were authored by CMDE reviewers. So, when you submit documents for review, you need to follow all the technical requirements stated in the technical guidance.