Health food registration refers to the review and approval process in which the drug supervisory and administrative department systematically evaluates and reviews the safety, health function and quality of the health food applied for registration. Regulatory authority decides whether grant registration to health food in accordance with legal procedures and requirements.

 

      The production and import of the following products shall apply for health food registration:

  • Health food that uses raw materials not included in the List of Raw Materials for Health Food (hereinafter referred to as “raw materials not included in the list”);
  • Health food imported for the first time (except health food supplemented with vitamins, minerals and other nutrients);
  • Health food imported for the first time (health food that has not been applied for marketing in China by the same country, the same enterprise or the same formula).

     

      Health food registration also has corresponding requirements for applicants:

  • The applicant for registration of domestic health food shall be a legal person or other organizations registered within the territory of China;
  • The applicant for registration of imported health food shall be the overseas manufacturer of listed health food. The application for the registration of imported health food shall be handled by its resident representative office in China or an agency within the territory of China entrusted by it.

NMPA Filing Process of Health Food

Health Food

Health Food Filing Materials

Domestic Health Food Filing Materials

Imported Health Food Filing Materials
Health food filing registration form, and the filer’s letter of commitment of legal responsibility for the authenticity of the submitted materials Documents certifying the principal registration of the filer
Documents certifying the principal registration of the filer Documents to certify that the products have been on the market for more than one year
Product formula materials The original text of the technical regulations or standards related to health food filed by the producing country (region) or the international organization. Overseas manufacturers guarantee that the health food exported to our country conforms to the provisions of relevant laws and administrative regulations and the requirements of the national food safety standards, as well as the self-inspection report to ensure the effective operation of the production quality management system.
Product production process materials The filer shall ensure that the source of the samples for inspection is clear and traceable, and the imported products for filing shall be the products for sale in its producing country (region).
Safety and health function evaluation materials Real sample of package and label instruction for products listed in the producing country (region)
The type, name and standard of packaging materials directly in contact with the product An enterprise that has the resident representative office of a foreign filing person in China handling the filing affairs shall submit a scanned copy of the Registration Certificate of the Resident Representative Office of a Foreign Enterprise in China
Product labeling, sample instructions Filing materials shall be in Chinese and materials in foreign languages shall be attached. Chinese translation of foreign language certification documents, foreign language label instructions, etc. shall be notarized by a notary office in China and be consistent with the original content.
Product technical requirements materials The supporting documents, power of attorney (agreement), etc. issued by overseas organizations shall be originals and shall use the official language of the country (region) where the product is produced. Documents shall be sealed by the filer or signed by the legal representative (or his authorized person), and be notarized  by notary office of the host country (region) and confirmed by the Chinese Embassy or Consulate in the host country. If the supporting documents, power of attorney (agreement), etc. are subject to validity period, they should be used within the validity period.
Inspection report of all items that meet the technical requirements of products issued by a legally qualified inspection institution If registrants can provide production and sales documents, quality management system or good manufacturing practice documents, commissioned processing agreement, and other supporting documents, they can list multiple products at the same time. When these products are filed at the same time, the original is allowed to be used for one product, and copies are used for other products, and the name of the filed product where the original is located shall be explained in writing; If these products are not filed at the same time, the original copy shall be used for one product, and the notarized copy shall be used for other products. The name of the filing product where the original copy is located shall be stated in writing.
Product name related search materials
Other materials indicating the safety and health functions of the product

Management Requirements for Health Food Registration Certificate

Registration Certificate
  • The registration certificate of health food shall contain product name, name and address of the registrant, registration number, date of issue and period of validity, health function, effective ingredient or iconic ingredient and its content, product specification, shelf life, suitable population, unsuitable population and precautions.
  • The attachment to the registration certificate of health food shall contain main contents of product label, instructions and technical requirements of the product.
  • Technical requirements for products shall include product name, formula, production process, sensory requirements, identification, physical and chemical indexes, microbial indexes, contents of functional ingredients or iconic ingredients and detection methods, difference indexes of loading or weight (net content and allowable negative deviation indexes), quality requirements of raw materials and auxiliary materials, etc.
Validity of Registration Certificate
  • The health food registration certificate is valid for 5 years.
  • The validity period of the health food registration certificate changed is the same as the original health food registration certificate.
Registration Certificate Number
  • The registration number format of domestic health food is: National Food Health Note G+4 digit age number +4 digit serial number;
  • The registration number format of imported health food is: National Food Health Note J+4 digit age number +4 digit serial number.