Special medical food, that is, formula food for special medical purposes, refers to the formula food specially processed and prepared to meet the special needs of people with limited eating, digestive and absorption disorders, metabolic disorders or special diseases for nutrients or meals. According to GB 29922-2013, foods for special medical purposes are divided into three categories according to different clinical needs and applicable populations, namely, full-nutrition formula foods, specific full-nutrition formula foods and non-full-nutrition formula foods. According to GB25596-2010, infant formula for special medical purposes refers to powdered or liquid formula designed for the nutritional needs of infants with special medical conditions such as special disorders, diseases or medical conditions. Under the guidance of doctors or clinical nutritionists, when taken alone or in combination with other foods, its energy and nutritional composition can meet the growth and development needs of infants with special medical conditions from 0 to 12 months old. China implements strict registration and approval management for formula foods for special medical purposes. The registration certificate of formula food for special medical purposes is valid for 5 years.
At present, the development of China's special medical food market is still in its early stage, and some enterprises at home and abroad have failed to accurately understand and grasp relevant national laws and regulations, resulting in the content and requirements of registration application materials and technical documents failing to meet the standards, and encountered many difficulties in the registration process. With abundant resources and rich experience, the company can deeply analyze the difficulties in the current process of special medical registration and application, the key points of product registration review and the specific requirements of on-site registration verification for enterprises, help enterprises understand the laws and regulations, master the relevant technical standards, specifications and registration and application procedures of special medical food, so as to avoid risks and successfully obtain the registration and approval of special medical food. The company can also provide special medical food research and development, system construction, clinical services, expert demonstration and other services.