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						Cost and Time for IVD China CFDA Registration 
 
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		| 
		 
		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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