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Cost and Time for IVD China CFDA Registration

ITEM

COST

TIME

Note

China CFDA Registration Legal responsibility Agency

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5 years

 

CFDA Consultation, Original files Prepare & Translation

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1 Month

 

Original Legal &Technical documents Pre-review

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1 Month

 

CFDA Application Dossier Draft, Compile, Review & Submit

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2-3 Months

 

IVD tests & Follow up

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3-6 Months

charge as actual amount

IVD Clinical Trial

Class III:1K-1.2K groups;  

Class II: 200-250 groups

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4~10 Month

The cost and time depend on Clinical trial protocol and additional CRO contract.

CFDA Evaluation & CFDA Approval & Follow up

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6-9 Months

 

Other (Document Notarization etc.)

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0.5-1 Months

 

Total:

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12-18

Months

Not include Clinical Trials cost

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