Health Food Supplements Registration in China
Enter China’s fast-growing health food and supplements market with confidence. Cisema’s regulatory specialists guide you through every step of the health food supplements registration or filing process with the State Administration for Market Regulation (SAMR), ensuring your products meet all compliance requirements for import, distribution, and sale.
Why Register Your Health Food in China
China’s health food supplement market is evolving, but access begins with compliance. Under the Food Safety Law of the People’s Republic of China and the Administrative Measure on Health Food Registration and Filing, every health food product must be filed or registered with the authorities before it can be imported, distributed, or sold.
For international manufacturers and brand owners, successful registration delivers clear advantages:
- Accelerate Approval: Ensure your product meets regulatory requirements from the outset to prevent costly approval delays or re-submissions.
- Ensure Compliance: Meet China’s complex safety, labeling, and technical standards with full compliance for peace of mind.
- Strengthen Brand and IP Protection: Secure your product registrations and safeguard your intellectual property in China’s tightly regulated market.
Cisema provides expert guidance through every step of the registration or filing process — helping you avoid delays, minimise risk, and succeed in China’s regulated health food market.
Cisema’s Health Food Registration Services
Determining the most appropriate registration approach for your product based on its composition, intended use, and health claims.
Ensuring that your ingredients, packaging, and functional statements conform to current SAMR requirements and Chinese health food regulations.
Managing the complete process, including SAMR filing or registration dossiers, supplementary notices, change applications, renewals, and certificate transfer or replacement requests.
Arranging the import of product samples and overseeing testing in accredited laboratories.
Cisema’s Domestic Responsible Agent (DRA) Services
- Preparation, submission, and follow-up for health food filings and registrations
- Management of new raw material applications, product renewals, and change requests
- Chinese label and packaging review for market compliance
- Coordination of sample imports and testing in SAMR-designated laboratories
- Supervision of functionality, hygiene, toxicity, and stability testing
- Guidance on technical standards, dosage forms, ingredients, and claims
- Support for regulatory audits and on-site inspections
- Monitoring of national standards and regulatory updates from SAMR and NHC
- Cooperation with authorities during market supervision activities
- Ensuring product safety, accurate labelling, and ongoing compliance
- Regulatory intelligence and updates tailored to your registrations
- Review of product claims, formulas, and technical specifications
- Guidance on structuring your market access strategy in China
How Health Food Is Classified in China
China regulates health food under the Food Safety Law and the Administrative Measure on Health Food Registration and Filing. These regulations divide health food into two categories:
- Nutritional supplements: Products containing vitamins and minerals from the list of 24 recognised nutrients, such as calcium, vitamin A, niacin, or DHA.
- Foods with specific health functions: Products permitted to claim one of 24 approved benefits, such as “helps enhance immunity”, “helps improve sleep”, or “helps regulate gut microbiota”
Products may take many dosage forms, including capsules, tablets, oral liquids, beverages, and teas. Therapeutic or disease-related statements, as well as unapproved health function claims, are strictly prohibited.
How Health Food Is Registered in China
To sell health food and supplements in China, foreign manufacturers must first appoint a Domestic Responsible Agent and submit a registration or filing application to the SAMR. The approval pathway depends on the product’s composition and claims:
- Filing: The faster route for supplements using approved ingredients and excipients listed in China’s regulatory directories, following permitted dosage forms and containing substances from the Health Food Raw Materials Directory.
- Registration: Required for products containing non-listed active ingredients or claiming specific health functions beyond basic nutritional supplementation. Registration requires safety evaluations, toxicology studies, as well as human and/or animal functional evaluation trials.
Filing certificates are issued indefinitely, while registration certificates are valid for five years and must be renewed before expiry.
Ready to confirm the correct registration pathway for your health food supplement to enter China?
Cross-Category Regulatory Services
Beyond health food supplement registration and filing in China, Cisema supports companies with diversified portfolios across multiple sectors, including:
- Pharmaceuticals & Biopharma
- Cosmetics
- Medical Devices & In-Vitro Diagnostics
- Industrial & Consumer Products
- Veterinary Medicines & Products
By integrating compliance expertise across these categories, Cisema acts as your single trusted partner for all China regulatory and market access needs.
Get In Touch
Have questions on our health food supplement registration services or need a quote? We are here to help.
