Cost and Time for IVD China NMPA Registration

◄ Cost and Time for IVD China NMPA 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

提示 Notice

不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

GACC Search Tools

GACC HS code, CIQ code & Tariffs

GACC Approved Food Manufacturers List

GACC Registered Overseas Food Exporters

GACC Registered Food Chinesse Importers

GACC Registration Food Categorisation

China Permitted Food Ingredients

GACC-2-2 White List for Primary Agricultural Product

China National GB Standards for Food

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◄ Cost and Time for IVD China NMPA Registration ►

China GACC Registration
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