Registration of Food Supplements in China


In China, nutrient supplements are regulated as one category under the umbrella term health food.  Health food is divided into two categories, one is functional health food, and the other is nutrient supplements.

  • Functional health food refers to health food with one or several of 27 functions
  • Nutrient supplements refer to products whose purpose is to supplement nutrients such as vitamins and minerals. 

Market Access restriction

An applicant for imported health food in China must be a legal overseas health food manufacturer (non-individual) and must apply for imported health food registration by either  using its office in China or have  a local representative in China.

important note:

  • Imported health foods must be produced and sold in the country of production for more than one year before they can be imported into China.
  • Multiple domestic local representatives responsible cannot be authorized for the same product.

Is the registration of Supplement Required in China?

  • If the product is considered as a functional health it must be registered. 
  • If the product is considered a Nutrient Supplement it does not need to registered but must be notified.  

Simplified registration flow:

The simplify process for Imported Registration is divided into 4 parts. The Local testing, A formal review, An expert review, An Administrative review .

Please Note: The steps outlined are a simplified process flow, it excludes the preparations steps prior to registration. 

Step 1. Testing agency:

Currently, the registration of imported health food must be carried out at the Nutrition and Food Safety Institute of the Chinese Center for Disease Control and Prevention .

Step 2. The formal review

The Acceptance Office known as the Administrative Acceptance Service Center of the State Food and Drug Administration is responsible for the acceptance of imported health food . They are responsible for the formal review of the company’s application materials, accepting those that meet the requirements, and issuing supplementary opinions for those that do not meet the requirements.

Step 3. The Expert review committee:

The Health Food Review Center of the State Food and Drug Administration is responsible for convening review meetings and organizing experts to conduct technical reviews of the declared products. Of the Expert committee finds no deficiencies in that application it will pass on their opinion for administrative review step 4. 

Step 4. The Administrative Review:

The Registration Department of the State Food and Drug Administration will review the products reviewed by the review committee, and approve them if they meet the requirements of relevant laws and regulations.

How long does it take to get a product to market in china?

The period of application for health food approval documents is closely related to the function of product application, and the application time ranges from 1-2 years, so specific product specific analysis is required. 

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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