May 21, 2025

China is one of the fastest-growing markets for Foods for Special Medical Purposes (FSMPs), driven by an aging population, rising chronic diseases, and increasing demand for clinical nutrition. However, entering this high-potential market requires navigating a stringent approval process governed by the State Administration for Market Regulation (SAMR).

If you're planning to register an FSMP in China, a deep understanding of SAMR requirements is critical for market success.

 

What Are FSMPs?

FSMPs are specially formulated foods intended for the dietary management of individuals with medical conditions or diseases. In China, FSMPs are categorized into:

  • Nutritionally Complete FSMPs (standard or disease-specific)
  • Nutritionally Incomplete FSMPs
  • FSMPs for Infants

These products must be used under medical supervision and are subject to a strict product-by-product registration process—even for imports.

 

Regulatory Oversight: Role of SAMR

The SAMR is China’s central authority for FSMP registration. Key regulatory references include:

  • Administrative Measures for FSMP Registration
  • GB Standards (e.g., GB 29922, GB 25596, GB 10765/10767 for infant FSMPs)
  • Technical Review Guidelines for FSMPs

Compliance with these documents ensures product safety, efficacy, and quality before market entry.

 

Step-by-Step: FSMP Registration in China

1. Pre-Registration Preparation

  • Define product classification and intended use.
  • Conduct a gap analysis against Chinese GB standards.
  • Prepare a full technical dossier, including:
    • Formula and manufacturing process
    • Stability data
    • Clinical/toxicological evidence
    • Label and claim verification

2. Dossier Submission

  • Submit application via SAMR’s online portal.
  • All documentation must be in Chinese, including translations of certificates and reports.

3. Technical Review

  • SAMR evaluates the product's safety, nutritional value, and intended use.
  • May include on-site audits for domestic or overseas facilities.

4. Sample Testing

  • Products must undergo testing at SAMR-designated labs.
  • Focus areas: nutrient levels, contaminants, microbiological safety, and labeling accuracy.

5. Approval & Licensing

  • Successful applications receive a Registration Certificate (valid for 5 years).
  • Any change to formula, label, or manufacturing site requires re-approval.

 

Common Compliance Challenges

  • Language Barriers: All materials must be accurately translated into Chinese.
  • Labeling Limitations: Claims must align with SAMR rules and cannot be misleading or therapeutic.
  • Clinical Evidence: Strong clinical data is needed, especially for disease-specific FSMPs.
  • Manufacturing Audits: Non-compliance with GMP or QC standards can cause delays.

 

Conclusion

The FSMP regulatory landscape in China is complex but navigable with the right expertise. SAMR’s rigorous standards ensure only scientifically validated, high-quality nutrition products reach patients.

By partnering with Maven Scientific Laboratories, you gain a trusted regulatory ally to streamline your entry into China’s dynamic FSMP market.