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