Is There A Recommended Number Of Subjects (or % Of The Pivotal Study) Needed For Registration In China? For A Class 3 Drug Device Combination Product For A Rare Disease.

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.