Food for special medical purpose（FSMP）
According to the Food Safety Law of the People’s Republic of China (revised in 2015), special medical purpose foods need to be registered and administrated as special foods. The product’s formula, production process, label, instruction, product safety, nutritional sufficiency and clinical effect of special medical purpose food need to be reviewed. The certificate of registration will be issued to the business that has completed the registration.
The specific implementation shall refer to the procedures and requirements specified in the “Administrative Measures for Registration of Formula Food for Special Medical Purposes” (the former State Food and Drug Administration Order No. 24) in 2016.
Special medical purpose food refers to:
- Satisfying eating restriction
- Digestion and absorption disorders
- Metabolic disorders or
- People with specific disease states
specially processed formulated foods for meeting the nutrients or dietary needs. Such products must be taken under the guidance of a doctor or clinical dietitian, including infant formulas for special medical purposes for 0 to 12 months old and formulas for special medical purposes for people over 1 year of age.
The applicant shall be a foreign manufacturer that intends to import formula food for special medical purposes to the People’s Republic of China.
Regulatory authority: State Administration for Market Regulation
Our Services include:
- Registration and recording consulting FSMP product export to China
- Chinese Regulation consulting for FSMP products
- Chinese Regulation for FSMP update monitoring
- Label compliance