Log in to the State Food and Drug Administration:

Registration of imported (including Hong Kong, Macao and Taiwan) health food products

Released on November 5, 2012

1. Project name: Health food approval

2. License content: Registration of imported (including Hong Kong, Macao and Taiwan) health food products

3. Implementation basis : "Food Hygiene Law of the People's Republic of China", "Health Food Registration Management Measures (Trial)", "Health Food Administrative Licensing Acceptance Review Key Points"

4. Charges: No charge

5. Quantity limit: There is no quantity limit for this license item

6. Catalog of materials submitted by the applicant:

Document number (1) Imported health food registration application form;

Document number (2) Copies of the applicant’s ID card, business license or other legal registration documents of the organization;

Document number (3) Provide the common name of the health food for which registration is applied for Search materials that do not have the same name as the names of drugs that have been approved for registration (retrieval from the State Food and Drug Administration government website database);

Document number (4) The applicant does not constitute a liability for patents that have been obtained by others. Guarantee for infringement;

Document No. (5) Provide trademark registration certification documents (no need to provide for unregistered trademarks);

Document No. (6) Product R&D Report (including R&D ideas) , function screening process, expected effects, etc.);

Data No. (7) Product formula (raw materials and excipients) and formula basis;

Data No. (8) Functional ingredients/iconics Inspection methods for ingredients, content and functional ingredients/iconic ingredients;

Document number (9) Production process diagram and detailed description and related research information;

Document number (9) 10) Product quality standards and their preparation instructions (including quality standards for raw materials and auxiliary materials);

Data number (11) Type, name, quality standards and selection basis of packaging materials that are in direct contact with the product;

Document No. (12) Test report and related information issued by the inspection agency;

Document No. (13) Product label and instruction manual sample;

Document No. (14) Product technical requirements and confirmation of successful upload of product technical requirements;

Document No. (15) Other information that is helpful for product review;

Document No. (10) 6) Two unopened samples in the smallest sales package;

If the function of data number (17) is not within the scope of the functional items announced by the State Food and Drug Administration, data must be provided in accordance with relevant requirements;

Document No. (18) Certification document issued by the relevant agency of the producing country (region) that the product manufacturer complies with the corresponding local production quality management regulations;

Document No. (19) If the permanent representative office of an overseas manufacturer in China handles registration matters, 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, a notarized power of attorney must be provided The original and a copy of the business license of the entrusted agency;

Document number (20) that the product has been produced and sold in the country (region) of production for more than one year. This certification document should be approved by the country (region) of production ) notarized by a notary agency and confirmed by the Chinese embassy or consulate in the country where it is located;

Document number (21) Relevant product-related standards of the producing country (region) or international organization;

Data No. (Twenty-two) Actual samples of packaging, labels, and instructions used when products are marketed in the country (region) of production. The actual samples should be arranged under the label and instruction manual samples;

Document No. (Two) 13) The quantity of samples from three consecutive batches is three times the amount required for inspection.