China Foods for Special Medical Purpose (FSMP) CFDA Registration Procedure Flow Chart of China

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China Foods for Special Medical Purpose (FSMP) CFDA Registration Procedure Flow Chart

Applicant Entrust a China Responsibility Agent (CRA)
Note: CRA isn't a distributor of Applicant

CRA apply CFDA China Responsibility Agent filing
Time: 1-2 weeks??

CRA guide Applicant prepare original Legal & Technical application files
Time: 1-2 weeks??

CRA translate, Pre-view the original Legal & Technical files,
and guide Applicant modify non-compliant files until meet the requirements of CFDA
Time:1-2 months

CRA arrange products testing in the CFDA designated laboratory
Time: 3-9 months, depend on the testing items,

CRA arrange Clinical Trial in the CFDA designated Institution
(Only Full nutritional formula food need)
Time: 3-12 months, depend on the Clinical Trial items,

CRA Compile all Application Dossiers According to the result
of product test and Clinical Trial, then formal submit to CFDA
Time:2-4weeks

CFDA relevant department Technical Evaluate the Application Documents
Time:3-6 months , depend on the CFDA

CFDA relevant department Site-audit the Applicant's production facility
Time:1- 3 months, depend on the CFDA

CFDA relevant department Sampling inspect the Applicant's product
Time:1- 3months, depend on the CFDA

CFDA approval the application and issue FSMP certificate to Applicant
Time: 1-2 months

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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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