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Food for Special Medical Purposes (FSMP), also known as "特殊医学用途配方食品" in Chinese, refers to formulated foods specially processed and prepared to meet the special nutritional needs of individuals with restricted dietary intake, digestion and absorption disorders, metabolic disorders, or specific disease states. It includes:
According to the "Food Safety Law of the People's Republic of China," the state strictly supervises and manages special foods such as Food for Special Medical Purposes (FSMP). FSMP needs to be registered with the State Administration for Market Regulation (SMAR) in order to be allowed to be marketed and sold in the Chinese market.
The applicant for registration should be:
A production company intending to produce and sell Food for Special Medical Purposes (FSMP) within China
An overseas production company intending to export Food for Special Medical Purposes (FSMP) to China
The applicant should have research and development and production capabilities that are suitable for the production of FSMP, establish a specialized research and development institution for FSMP, employ dedicated product development personnel, food safety management personnel, and food safety professionals. They should establish a production quality management system in accordance with good manufacturing practices and have the capability to conduct batch inspections for all items specified in the national standards for FSMP.
The FSMP registration certificate is valid for 5 years and can be modified, but the corresponding application must be completed.
When the certificate is about to expire and there is a need to continue production or importation, an application for renewal should be submitted to the National Administration for Market Regulation no later than 6 months before the expiration date.
FSMP has an exclusive logo, the "小蓝花" (Little Blue Flower), which is the most important distinguishing mark from other foods.
For the registration of specific full-nutrition formula food, a clinical trial report should also be submitted supporting documents related to the registration application
For the registration of imported Food for Special Medical Purposes (FSMP), the following materials should also be submitted:
If the overseas applicant establishes a representative office in China to handle registration affairs, a copy of the "Registration Certificate of Foreign Enterprise Permanent Office in China" should be submitted.
If the overseas applicant entrusts a domestic agency to handle registration matters, the original notarized power of attorney and its Chinese translation, as well as a copy of the business license of the authorized agency, should be submitted.
Inspection report of trial samples
Stability testing (including factor testing, accelerated testing, and long-term testing)
Clinical trials (only for specific full-nutrition formula food)
+86 571 8659 2517
+86 180 5841 8258
info@zmuni.com