In 2017, CFDA approved 5993 domestic Class II initial registrations and 867 domestic Class III initial registrations. In contrast, CFDA only approved 389 imported Class II initial registrations and 189 imported Class II initial registrations. Imported Class III initial registration was down 68.13% from 593 in 2016. We believe this is primarily due to China local clinical trial requirement and increased CFDA application fee. With the new regulation on CFDA accepting foreign clinical data, we expect the increase of imported Class II initial registrations in 2018.
Please refer to the following table for details on all 2017 registration details, including initial registration, registration extensions and registration license change.
| Registration Type | Initial Registration | Registration Extension | License Change |
|---|---|---|---|
| Domestic Class II | 5993 | 7193 | 4584 |
| Domestic Class III | 867 | 1616 | 489 |
| Imported Class II | 389 | 1655 | 555 |
| Imported Class III | 189 | 1631 | 592 |
Summerized by J MedTec