GACC Registry Single Window e-Service | Home | GACC | FAQs | Login | Registry Signup | Contact us |

GACC Registration Single Window
-  e-Service Center  -

Cost and Time for IVD China NMPA Registration

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

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