Tags: | NMPA | Medical Device | IVD | 药监局 | 医疗器械 | 诊断试剂 |
ITEM
COST
TIME
Note
China CFDA Registration Legal responsibility Agency
contact us!
5 years
CFDA Consultation, Original files Prepare & Translation
1 Month
Original Legal &Technical documents Pre-review
CFDA Application Dossier Draft, Compile, Review & Submit
2-3 Months
IVD tests & Follow up
3-6 Months
charge as actual amount
IVD Clinical Trial
Class III:1K-1.2K groups;
Class II: 200-250 groups
4~10 Month
The cost and time depend on Clinical trial protocol and additional CRO contract.
CFDA Evaluation & CFDA Approval & Follow up
6-9 Months
Other (Document Notarization etc.)
0.5-1 Months
Total:
12-18
Months
Not include Clinical Trials cost