CRA translate, Pre-view the original Legal &
Technical files, and guide Applicant modify non-compliant
files until meet the requirements of
CNCA Time:1-3 months
Applicant submit
CNCA Application to Country of Origin
Regulatory Authority Time: depend on the Origin Regulatory Authority
Country of Origin Regulatory Authority Preliminary
examination the Application documents and recommend to
CNCA Time: depend on the Origin Regulatory Authority,
CNCA Evaluate the Application Documents of Applicant Time:2-4 months
CNCA Site-audit the Applicant's production facility Time:3-12 months, depend on the CNCA,
CNCA approval the application and issue registration No. to the
Applicant Time: 2-4 weeks
CNCA: Certification and Accreditation Administration of the People?ˉs Republic of China AQSIQ: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
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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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