Health Supplement Registration China â SAMR Filing & Blue Hat Certification for Dietary Supplements
Ensure your vitamins, minerals, herbal extracts, and other dietary supplements gain health supplement registration to enter the Chinese market. Our remote team manages the entire SAMR filing and blue hat certification process, keeping your products compliant with China's health food regulations.
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What Is Health Supplement Registration in China?
Health supplement registration (commonly called blue hat certification) is the mandatory approval process administered by the State Administration for Market Regulation (SAMR) for all dietary supplement products sold in China. Whether your product is a multivitamin, mineral tablet, fish oil softgel, or herbal extract capsule, you must obtain a health food registration certificate (ćœéŁć„æłš) before the product can be legally imported and distributed. This process involves extensive safety and function testing, as well as a rigorous technical review that can take anywhere from 18 to 24 months for full registration, or a faster filing route for certain nutrient supplements.
Our dietary supplement registration service guides foreign brands through the entire China health food compliance journey. We coordinate toxicology and function tests with CNAS-accredited labs, prepare all technical dossiers in Chinese, and communicate directly with SAMR reviewers on your behalf. With our support, you can navigate the imported health supplement registration requirements without a local office.
Products That Require Health Supplement Registration
All dietary supplement products making health function claims must complete health food registration or filing. Common categories include:
- Vitamins & Minerals: multivitamin tablets, calcium with vitamin D, iron supplements, zinc lozenges
- Herbal Extracts: ginseng, ginkgo biloba, turmeric, milk thistle, echinacea products
- Fish Oil & Omega-3: fish oil softgels, krill oil, algae DHA, evening primrose oil
- Probiotics & Prebiotics: lactobacillus, bifidobacterium capsules, fiber supplements
- Protein & Amino Acid: whey protein powders, amino acid tablets, collagen drinks
If your product uses ingredients from the Health Food Raw Material Directory and only makes approved nutrient function claims, you may be eligible for the filing (〿Ą) route, which is significantly faster. Contact us with your product specifications for a free health supplement registration assessment.
Documents Required for Health Supplement Registration
To apply for health food registration in China, foreign manufacturers need to prepare the following (we provide translation and document preparation support):
- Product formula with exact ingredient quantities and rationale for ingredient usage
- Manufacturer business license and GMP certificate (health food GMP is preferred)
- Technical product specifications and detailed manufacturing process flow chart
- Safety toxicology test reports and function assessment reports (we arrange testing)
- Stability test data and proposed shelf life
- Chinese label design according to GB 16740-2014 and health food labeling regulations
- Letter of authorization for the Chinese legal representative (our team)
Health Supplement Registration Timeline & Cost
The typical health food registration process takes 18 to 24 months from sample submission to certificate issuance, depending on product complexity and lab schedules. For nutrient supplements that qualify for the filing route, the timeline can be shortened to around 6 to 8 months.
Cost factors include safety and function testing fees, government review charges, and professional service fees. We provide a fixed-price proposal after evaluating your product â no hidden costs.
đ Get your personalized health supplement registration quote: Contact us with your product details and receive a detailed fee breakdown within 24 hours.