Registration of Health Food in China Overview

In China, health food is usually defined as food products that have specific health functions or supply vitamins and (or) minerals. With the goal of regulating the body's function, health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute, or chronic health effects to the human body. 

The definitions/names of these food products in different countries are different:

1. China: Health Food

2. EU: Food Supplement

3. USA: Dietary Supplement

4. Canada: Natural Health Product

5. Australia: Complementary Medicines

6. Korea: Health Functional Food

7. Japan: Food with Health Claims (FHC)

With the continuous growth of the Chinese market, global companies are optimistic about China's huge health food consumer market and hope to enter China. Before the health food is imported into the Chinese market, it must be approved by the Chinese state and obtain the "Health Food Approval Certificate" or "Health Food Record Certificate" issued by the State Administration for Market Regulation before customs clearance. Products without approval shall not be sold in the Chinese market, otherwise, severe penalties will be imposed upon investigation. Therefore, applying for health food approval is the first step for foreign health food to be imported into the Chinese market. 

Precautions for Health Food Registration and Filing

All functional health foods must go to the China National Medical Products Administration (NMPA) to apply for registration.

Chinese health food into nutrient supplements and functional health food are two categories. Nutrient supplements require filing applications. Functional health foods are divided into 27 categories, and registration applications are required. There are differences in the application cycle and fees. Therefore, only by determining the function of the product to be declared can a budget with reference value be made.

Health food filing/ registration application is not submitted directly to the NMPA, but to do the first test, test qualified to submit an application to the NMPA.

The application fee for health food is calculated on a single-product basis. As long as the product name is different, you must apply. It is not possible to apply only one symbol for a brand or a series of products.

The health food registration approval is valid for 5 years, and the re-registration extension is required after 5 years. The record certificate is valid for a long time and does not need to be renewed.

Our Services

TOSUN Pharmaceutical can provide you with one-stop healthcare product regulatory consultation and registration services. Are you interested in importing your products to China? Please kindly contact us, our Product Registration services can ensure a hassle-free process to expand your business.