Foods for Special Medical Purpose (FSMP) Registration in China

Updated on 27 March 2018

Foods for Special Medical Purposes (FSMP) are made from a special processing formula and used to meet the special dietary needs for people who have limited feeding, digestion absorption disorders, metabolic disorders or specific disease conditions, including the FSMP for infants 0-12 months of age and the FSMP for people over one year old.

In accordance with the Food Safety Law of China (2015 version), FSMP products shall be registered with CFDA. According to the Notice on Transitional Period of FSMP Registration (No.139, 2017), since January 1, 2019, all FSMP products produced in China or imported to China shall get the FSMP registration certificate under CFDA, and indicate the registration number on the label and instruction book.

Classification of FSMP

*Currently, for specific full nutritional formula food, the adjustable nutrient indexes of 8 specific categories (No.1, 2(COPD), 3, 4, 8, 9, 10，13) are available according to Q&A of GB 29922-2013.

FSMP Laws and Regulations

Applicant Qualification

According to the Administrative Measure on FSMP Registration, no matter for domestic or imported FSMP products, the applicants shall be actual manufacturers who have production capacity..

Registration Procedures

Dossier requirements

• Application form
• Products R&D reports, formula materials and formula design basis
• Product process materials
• Product standard requirements
• Samples of product label and instruction book
• Test reports
• Evidence material of R&D capacity, production capacity and test capacity
• Clinical trial reports (only required for specific full nutritional formula foods)
• Application related certificates

For imported FSMP products, there are some additional certificates required:

• Copy and Chinese version of qualification certifying document issued by government authorities or legal service agencies in the producing country (region) of origin proving that the applicant is the overseas manufacturer;
• Copy and Chinese version of certifying document issued by government authorities or legal service agencies in the producing country (region) of origin proving that the product is allowed to be sold on the market. If the product is not available for sale, this document can be exempted.
• For registration affairs run by an overseas manufacturer’s Permanent Representative in China, a copy of the "registration certificate of overseas enterprise’s permanent Chinese representative offices" shall be provided;
• For registration affairs run by domestic agencies entrusted by overseas manufacturers, the applicant shall provide the original notarized certificate of entrustment and its Chinese version, and a copy of the business license of the agency entrusted.

Test Items

The following tests are required for FSMP registration in China:

1) Tests of all items listed in product standard;

2) Stability tests**;

3) Clinical trials***;

4) Other tests if necessary.

Note:

**. For specific full nutritional formula food and part nutritional formula food, the stability test reports shall be submitted, but for full nutritional formula food andFSMP for 0-12 months of age, the applicant can keep the records for further examination.

***The clinical trials are ONLY required for specific full nutritional formula food.

Our Services

CIRS is providing one-stop services for China food regulatory compliance. For FSMP, we offer the following services:

1. Training on FSMP Regulation

2. FSMP Regulation Update Monitoring

3. FSMP Registration

4. Single Technology Services

• Pre-market Investigation
• Classification Analysis and Formula Review
• Chinese Label and Package Insert Design
• Translation
• Test Arrange and Monitoring
• Other customized service