Cost and Time for IVD China CFDA Registration

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

1 Month

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