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Cost and Time for disinfectant China NHFPC(MOH) Approval

 

STEP

ITEM

COST

TIME

Work content

1

China NHFPC(MOH) Registration Legal responsibility Agency

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4 years

On behalf of the applicant, communicate with the NHFPC(MOH) and relevant government departments, in the 5 years certificate validity period

2

Original Legal &Technical documents prepare and Translation (English-Chinese,)

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1 Month

1.Explanation the NHFPC(MOH) registration procedure and regulation for Applicant in detail

2. Provide the list of application dossiers need to be submitted, including technical & legal documents, and describe the requirements of each documents in detail.

3. Translate all Original Legal &Technical documents provided by Applicant,

3

Original Legal &Technical documents Pre-review

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1 Month

1. Pre-review all Original Legal &Technical documents, and instruct Applicant to revise the gaps where are not met. Requirements of NHFPC(MOH)

2. Find out defects factors in the original Legal &Technical documents£?Analyse its resulting risk of registration.

4

NHFPC(MOH) Application Dossiers Draft, Edit, Compile and Pre-review

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2- 3 Months

1. Draft and Compile all of NHFPC(MOH) application Dossiers (20 documents), base on the Original Legal & Technical documents provided by Applicant.

2. Find relevant expert for pre-evaluation when necessary, and ensure the completeness of dossiers.

3. Legal Document translation Notarization: LOA, FSC,GMP,etc

5

NHFPC(MOH) designated Lab Testing & Follow up

(Time controlled by Lab )

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3 - 5 Months

1. Prepare technical dossiers required for tests.

2. Arrange test and follow up the test procedure,

3. Communicate with NHFPC(MOH) designated Lab?ˉs relevant officers to promote pass of testing.

6

NHFPC(MOH) Technical Evaluation & hygiene llicense Approval Follow up

(Time is controlled by NHFPC(MOH) ),

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3 -4 Months,

1. Follow up Functional healthy food technical evaluation in NHFPC(MOH), communicate with reviewing technological expert, and solve problems met during review at any time.

2£?Promptly submit supplemental dossiers required by NHFPC(MOH) if technical dossiers need to be corrected.

3. Communicate with NHFPC(MOH) relevant officers, promote get NHFPC(MOH) approval and cerificate issue.

??

TOTAL

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10 -14 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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