Common FAQ

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.

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.