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 Compile all Application Dossiers According
to the result of product test, then formal submit to
CFDA
Time:2-4 weeks
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-
3 months, depend on the CFDA
CFDA approval the application and issue 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;
:
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