Timeline and Budget for Health Food Access to the Chinese Market

1. Compliance Procedures of Health Food Access to the Chinese Market

China,Health,Food,Regulation,Registration,Filing,Timeline

Among above 3 steps, “health food registration or filing” is the most important step. It is a prerequisite for imported health food to enter the Chinese market, and takes a certain amount of time and cost to get the final registration or filing approval. Overseas companies who are interested in China market need to have an overall understanding of health food registration and filing requirements in China before starting relevant projects.

2. Imported Health Food Registration or Filing

In accordance with Food Safety Law of China (2015 version), companies who plan to place health food in Chinese market shall apply and obtain the health food registration certificate or filing certificate.

2.1 Imported Health Food Registration

  • Registration background

Application scope

All imported health food (excluding nutrition supplement that only provides vitamin and/or mineral)

Applicant qualification

Oversea manufacturers

(refer to the legal person and other organization)

Authority

SAMR (former CFDA)

  • Estimated registration timeline

Registration procedures

Estimated duration

Feasibility analysis

7 workdays

Original documents and test sample preparation

Depends on the applicant

Registration tests

8-16 months

Dossier preparation and submission

About 3 months

Registration application acceptance

5 workdays

Transfer materials to Health Food Review Center

3 workdays

Technical evaluation

60 workdays

Re-test and on-site verification if necessary

Case by case for imported products

Submit supplement dossier if necessary

Within 3 months

Report to SAMR

5 workdays

SAMR make approval decision, issue registration certificate

33 workdays

Total

2-3 years

  • Estimated registration budget

There are two parts of budget: test fee and consulting fee.

Items

Estimated budget

Budget arrangement

Test fee, which include:

Self-tests;

Functional components or characteristic ingredients tests, hygiene test and stability test;

Methodological validation on functional components or characteristic ingredients test methods;

Toxicology test;

Animals function and (or) human feeding trials.

See the Guideline

See the Guideline

Consulting fee

2.2 Imported Health Food Filing

  • Filing background

Application scope

The imported nutrition supplements of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.

Applicant qualification

Oversea manufacturers

(refer to the legal person and other organization)

Authority

SAMR (former CFDA)

  •  Estimated filing timeline

Filing procedures

Estimated duration

Filing feasibility analysis

3 workdays

Original documents and test sample preparation

Depends on the applicant

Filing tests

About 4 months

Dossier preparation and submission

About 1 months

Submit supplement dossiers if necessary

Case by case (usually within 1 month)

Get filing approval

Case by case (usually within 1 week)

Total

About 6 months

  • Estimated filing budget

There are two parts of budget: test fee and consulting fee.

Items

Estimated budget

Budget arrangement

Test fee, which include:

3 batches of functional components or characteristic ingredients tests, hygiene tests, and stability test;

3 batches of tests including all items listed in product technical requirements;

See the Guideline

See the Guideline

Consulting fee

Section 4 of <Guideline on Health Food Exportation to China> which is issued by CIRS provides detailed information according to below structure:

1. Compliance Procedures of Health Food Access to the Chinese Market

2. Imported Health Food Registration or Filing

  • 2.1 Imported Health Food Registration (including registration process, dossier requirement, test requirement, timeline, budget, etc.)
  • 2.2 Imported Health Food Filing (including filing process, dossier requirement, test requirement, timeline, budget, etc.)

The summary of each section in the Guideline is introduced by a series of articles which are available as following. If it is of your interest, please kindly click to get information as following.

Section 1: Information to Know before Health Food Exportation to China

Section 2: How Many Health Food are Registered in China?

Section 3: Chinese Health Food Regulation in Present and Future

Section 4: Timeline and Budget for Health Food Access to Chinese Market

Section 5: How does Chinese Government Supervise the Health Food?

Section 6: Cross-Border E-Commerce (CBEC): New Opportunity for Imported Health Food to Enter the Chinese Market

In addition, if you would like to get the <Guideline on Health Food Exportation to China> to get more complete information, please click here to order it.

Editor:

CIRS Food Technical Team: Established in 2012, CIRS Food Technical Team has more than 80% masters with degrees of Food Safety or Food Engineering and more than 50% members from oversea renowned universities. Since it was founded, based on the rich experience of regulatory compliance and deep understanding of Chinese food regulations and industry, food specialists have made comprehensive and reasonable solutions for many oversea food companies to complete Chinese food regulatory compliance progress.

If you have any other questions, please contact us at service@cirs-reach.com.

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