Food Safety and Compliance Service

In order to regulate the registration of food for special medical purposes (FSMP), strengthen registration management, and ensure the quality and safety of FSMP, the State Food and Drug Administration of China (SFDA) formulated and promulgated the "Administrative Measures for the Registration of Food for Special Medical Purposes" (hereinafter referred to as the "Measures"), which stipulate the application and registration conditions and procedures, product development requirements, clinical trial requirements, labeling and instructions requirements, as well as supervision and management and legal responsibilities, and other relevant contents for FSMP. The "Measures" were implemented on July 1st, 2016.

What is FSMP?

FSMP refers to especially formulated foods that are produced to meet the special requirements for nutrient or meals of people who suffer from eating limitation, disorder of digestion and absorption, metabolic disorders or special disease state, these products shall be eaten individually or with other foods under the guidance of doctors or clinical dietitians.

Foodmate provides technical support and audit ancillary work for the registration work of the customer, helping overseas manufacturers of imported foods obtain registration certificates as soon as possible and avoid unnecessary mistakes. The services may include the following content:

Preparation of registration materials.

Expert Review: Review the provided documents and deliver review opinions.

Sample inspection guidance: prepare inspection materials, and contact inspection unit to make necessary inspection on the product, track the whole inspection progress, and verify the inspection report.

Clinical trials (specific full nutritional formula food) coordination: coordinate with clinical trial agent to conduct clinical trials, including preparing necessary data, submitting relevant information and samples, tracking the progress, handling problems encountered during clinical trials, and reviewing clinical trial reports.

Material Modification: guide clients to modify and supplement registration dossiers, and help clients to set up rectification plan for factories.

On-site Preview (If necessary).

Material correction guidance: guide the client to make material correction and revision after receiving the correction opinions issued by review institution.