Cost and Time for IVD China CFDA Registration of China

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Disinfectant

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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Important Note

Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all CFDA and SFDA on this website default to NMPA, GACC defaults to GACC;　

	Our Service Items
CFDA	CFDA Registration for Cosmetics, Health Food, Infant Formula, FSMP , Medical Device, IVD,Drug etc.
GACC	GACC Registration for Foreign Food Facility and Exporter
CNCA	CNCA Registration for Foreign Dairy, Meat, Aquatic Foods Facility
CIQ	CIQ Inspection & filing for Foods & Cosmetics Chinese Labeling, Batteries & Coatings Product etc.
MOA	CNCA Registration for Foreign Animal Feed, Dog, Cat Food, GMO etc.
MOH	MOH Registration for Disinfectant, New Food & Cosmetic Ingredient
GB	China National GB Standards English Translation & GB Standards Item Test
	Imported Commodity China Regulatory Compliance Review & Consulting

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