Registration of Imported Health Food Products
Basis for implementation: “People’s Republic of China Food Hygiene Law,” “Provisions for Health Food Registration (Interim)”, “Focuses for Acceptance and Inspection of Health Food Examination and Approval”.
Quantity restrictions: No quantity limit for the licensing
List of application documents:
- Imported health food registration application form;
- Copies of applicant’s ID card, business license or legally registered certificates of other institutions;
- Retrieval information (retrieved from CFDA government website database) proving that the generic names of the health foods being applied don’t overlap with the names of products already registered;
- Letter of guarantee ensuring non-infringement of patents already obtained by others
Information Number (five) Provide trademark registration certificates (unregistered trademarks can do without);
- Product development report (including research and development ideas, feature selection process, the expected functions, etc.);
- Product formulation (APIs and excipients) and formula basis;
- Functional components/ Characteristic ingredients, contents and functional components / testing methods of characteristic ingredients;
- Production process diagram and detailed description, and the associated research data;
- Product quality standards and preparation explanations (including quality standards of APIs and excipients);
- Types, names, quality standards and selection basis of packaging materials in direct contact with the product;
- The testing report issued by the testing institutions and related information
Requirements for application dossier:
General requirements for the dossier:
1. The first page of the dossiers is a list of the application documents, which shall be arranged in order required by the “attached information” in “Health food registration application form”. Each dossier shall have a cover page indicating the name of the product and the applicant, and the dossier title shall be marked at the upper right corner. The dossier shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The full set of dossier shall be punched and bound into a book.
2. The application dossier shall be printed in A4 size paper (Chinese characters not less than font-size junior 4 in Song typeface, English not less than font-size 12), the contents shall be complete, clear, without alteration.
3. Registration application for new products shall provide 1 original and 8 copies of application dossier. Copies shall be fully identical with the original and shall remain intact and clear.
4. Except for the “Imported health food registration application form” and testing reports issued by testing institutions, the application dossier shall be stamped page by page or cross-page stamped (for joint application, the seals of all applicants shall be stamped), and the seal shall be stamped in the text place. The seals shall comply with the state’s relevant provisions for standard management and legally binding. If the applicant for imported health food has no official seal, the dossier can be stamped with seal or signed by the legal representative instead.
Application process diagram:
Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
License validity and renewal:
“Imported health food approval certificate” is valid for five years, if it’s validity period is to be extended after the expiry, the applicant shall apply for renewal three months before the expiry.