China NPMA / CFDA Approved
Medical Supplies & PPE
Certificate Validation

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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

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

 
 

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Note
Since 1-Sep, 2018, CFDA (China Food and Drug Administration) has changed its name to NMPA (National Medical Product Administration). So, all CFDA and SFDA on this website default mean NMPA.  
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