If you follow the health food procedure, you need to apply for an import health food approval document from the China SFDA first, and only after obtaining the approval document with the batch number of Guoshijianzi J******** can you enter China. Sale. Please see below for the application materials required to apply for approval. An important point is that the product must have been produced and sold abroad for more than one year. Another thing to note is that the applicant stated in the approved document is a foreign manufacturer. This is the biggest difference from before July 2005. Anyone who wants to be an agent for imported products must pay attention to it and make an agreement with the foreigner first.
Domestic and imported health food declaration information items (1):
(1) Health food registration application form.
(2) A copy of the applicant’s ID card or business license.
(3) Provide search materials (searched from the State Food and Drug Administration government website database) that the common name of the health food applied for registration does not overlap with the name of the drug that has been approved for registration.
(4) The applicant’s guarantee that the patent obtained by others does not constitute infringement.
(5) Provide trademark registration certification documents (not required for unregistered trademarks).
(6) Product research and development report (including research and development ideas, function screening process, expected effects, etc.).
(7) Product formula (raw materials and excipients) and formula basis. Sources of raw materials and excipients and basis for use.
(8) Functional ingredients/iconic ingredients, content and testing methods.
(9) Schematic diagram of the production process and its detailed description and related research materials.
(10) Product quality standards and instructions for drafting them (including quality standards for raw materials and excipients).
(11) Types, names, quality standards and selection basis of packaging materials that are in direct contact with products.
(12) Test report and related information issued by the inspection agency, including:
1. Test application form;
2. Inspection by the inspection unit Acceptance and signature notice;
3. Safety toxicology test report;
4. Functional test report;
5. Doping test report; ( Limited to registration applications for relieving physical fatigue, losing weight, and improving growth and development functions)
6. Functional ingredient test report;
7. Stability test report;
8. Hygiene test report;
9. Other inspection reports (such as raw material identification report, strain virulence test report, etc.)
(13) Product label, Sample instructions.
(14) Other information helpful for product review.
(15) To apply for imported health food registration for 2 unopened samples in the smallest sales package, in addition to the above application materials, the following information must also be provided: The product is produced and sold in the producing country (region) 1 Certification documents that are more than 10 years old must be notarized by the notary authority in the country (region) of production and confirmed by the Chinese embassy or consulate in the country where the product is produced. Documents certifying that the product manufacturer complies with the corresponding local production quality management regulations issued by relevant institutions in the country or region of production. Relevant product-related standards of the producing country (region) or international organization. Actual samples of packaging, labels, and instructions used when the product is launched in the country (region) of production. The quantity of samples from three consecutive batches is three times the amount required for inspection. If the registration affairs are handled by the permanent representative office of an overseas manufacturer in China, a copy of the "Registration Certificate of the Foreign Enterprise's Permanent Representative Office in China" shall be provided. If an overseas manufacturer entrusts a domestic agency to handle registration matters, it must provide the original notarized power of attorney and a copy of the entrusted agency's business license.