China Special Medical Purpose Food Registration

Regulation Background of Special Medical Purpose Food in China

Food for Special Medical Purposes (FSMP) is specially processed and formulated to meet the nutritional needs of special populations. In order to regulate the registration of FSMP, strengthen the registration management, and ensure the quality and safety of FSMP, the National Medical Products Administration (NMPA) announced in 2016 and implemented the Management Measures for Registration of Food for Special Medical Purposes. The NMPA reviews FSMP product formulations, production processes, labels, instructions, nutritional adequacy, product safety, and clinical effects for special medical purposes based on the registration applications submitted by applicants and decides whether to grant registration.

According to the Notice on the Transitional Period for FSMP issued in 2017, starting from January 1, 2019, all FSMP products manufactured in China or imported into China must obtain the FSMP registration certificate prescribed by the NMPA, with the registration number on the label and instructions.

About Us

Our company provides scientific and regulatory support for the registration of China's special medical purpose food.

Applicants for domestic or imported FSMP products must be actual producers with production capacity. Foreign producers need to handle registration affairs through their permanent representative agencies in China or entrust a domestic agency (such as our company) to handle registration matters.

In terms of China FSMP registration, our company is equipped with professional technical knowledge and mature service processes. We help our clients improve their knowledge and regulations of special medical use formula foods, infant formula foods, and special dietary foods. We also help them quickly meet China's requirements for manufacturing enterprises and obtain approval and production permits successfully.

Our China FSMP Registration Services

We provide one-stop China food compliance services to our global clients, including various forms of regulatory consulting (network, telephone, face-to-face), reviewing whether FSMP products comply with Chinese regulations, evaluating the testing and production capacity of production enterprises, and getting administrative approval of FSMPs. For domestic and international FSMP compliance, our company provides the following services:

• Regulatory consultation
• FSMP management regulations
• FSMP registration process and registration strategies
• Customized registration consulting and training
• FSMP product compliance review
• Review of the product formula, label, ingredients, and additives
• Product development consulting
• Pre-review of FSMP product registration
• Qualification review of the manufacturer
• On-site audit of production plants
• Communication with competent authorities and authoritative experts
• FSMP registration
• Preliminary assessment of the feasibility, timeline, and cost of registration
• Registration dossier preparation and submission
• Translation and notarization of the Chinese label and documents
• Registration test supervision
• Follow-up of the registration results
• Update and renewal of registrations
• Communication with the evaluation department and experts
• Other customized services
• FSMP product classification analysis
• Design and production of Chinese labels and instructions
• Chinese and English translation

Our FSMP Registration Workflow

If you need help or have a question, please feel free to contact us for more details.