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Imported/Domestic Health Food Registration

Imported Health Food Application Document

   Source��   outao

1.Imported Health Food Registration Application Form.

2.Applicant identity card copy or business license copy.

3.Searching documents about non-duplicate of common name with approved drugs (search on CFDA website database).

4.Guarantee about non-infringement with other approved patent.

5.Trademark registration evidence (Not provide if not registration of trademark).

6.Products development report (including design thinking, function screening process and intended effect).

7.Product formula (raw materials and accessories) and formula basis. Source of raw materials and accessories and use basis.

8.Function elements/major elements, concentration and its control method.

9.Flow chart and detailed description of  manufacturing and related research documents.

10.Products Quality Standards and its drafting description (including raw material accessories).

11.Type, name and quality standards of material directly contacted with products and its selection basis.

12.Experiment report of testing institution, and its related materials, including:
1)Testing application form;
2)Testing acceptance receipt from testing institution;
3)Safety toxicology test report;
4)Function testing report;
5)Analeptic testing report;(only apply to registration of health food to relieve energy exhausting, reduce weight and improve growth and development)
6)Functional element testing report;
7) Stability study report;
8) Sanitation study report;
9) Other testing report (such as raw material identification report and culture.

13.Sample of labeling and package insert.

14.Other documents that help product review.

15.2 unopened minimum package samples.

16.Document evidence of sale for over 1 year at manufacturer country (region), which should be notarized by notarization office.

17.Production and Quality System certificate conformed to local production and quality regulation issued by manufacturer country or region regulatory office.

18.Related standards in manufacturer country or international organization.

19.Package, labeling and Instruction of Use samples used at manufacturer country (area).

20.3 successive batch samples, the amount is 3 times of testing amount needed.

21.If foreign manufacturer assign resident office in China to deal with registration, should provide “certificate of registration of resident office of foreign enterprises”copy.

22.If foreign manufacturer assign domestic representative to deal with registration, should provide original notarized authorizing letter and copy of business license of the agent.