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    SAMR Food for Special Medical Purpose (FSMP) Registration

    China,Food,FSMP,Registration,Domestic,Import,SAMR

    Under the Administrative Measures for Registration of Food for Special Medical Purposes (CFDA Order No. 24) released in 2016, companies shall submit Food for Special Medical Purposes (FSMP) registration to State Administration for Market Regulation (SAMR). The registration not only applies to domestic FSMP produced and marketed in China, but also to imported FSMP produced abroad but put on the Chinese market.

    Who Shall Register?

    • Manufacturers of FSMP in China.

    • Foreign manufacturers selling FSMP to China.

    Who Can Be the Applicant (The Certificate Owner) of Registration

    Domestic FSMPManufacturers of FSMP in China
    Imported FSMPManufacturers of FSMP abroad

    Manufacturers in China can submit a FSMP registration or appoint a local agent to do so. Foreign manufacturers must appoint a local Chinese agent like CIRS China to submit the FSMP registration. The local agent should be knowledgeable and qualified to carry out the registration.

    Our Services

    CIRS China fulfils all the qualifications and requirements of being a local Chinese agent (registered capital, expertise, etc). We provide all the necessary services in one package to complete registration at the most competitive price in the market.

    Our services include:

    Formula Compliance Review
    (Registration Feasibility Analysis)

    • Evaluation of whether the recipe is compliant with Chinese regulations

    • Preparation of a FSMP registration proposal

    Health Food Registration

    • Data evaluation and data gap analysis

    • Writing testing proposal, sending sample to certified labs

    • Translation and notarization of certifying documents

    • Dossier preparation and submission

    • Tracking the registration status and communication with SAMR

    Label Review

    • Review the Chinese packaging/label and provide modification suggestions

    Previous: SAMR Infant Formula Milk Powder Registration
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    Relevant Services
    SAMR Infant Formula Milk Powder Registration
    Nutrition Test and National Standard (GB) Compliance Test
    SAMR Health Food (Dietary Supplement) Registration/Filing in China
    Genetically Modified Microorganism Food Additive Registration in China
    Formula Review on Pre-packaged General Food
    Contact Us
    +86 571 8720 6574（CN）
    +353 1 477 3710 （EU）
    +44 20 3239 9430 （UK）
    +1 703 520 1420 (USA)
    +82 2 6347 8816 (KR)
    service@cirs-group.com
    Relevant News
    Explosive Growth of FSMP Products in the First Half of 2023 –Bringing the Total to 125 Approved Products
    Jun 28, 2023
    CIRS FAQ: Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production? Vol. 05, 2023
    May 25, 2023
    The Application Progress of Human Milk Oligosaccharides (HMOs) in China
    Mar 30, 2023
    Seven Important Changes — the Draft for General Rules on Infant Formula Food for Special Medical Purposes (GB 25596)
    Feb 27, 2023
    The Pain Points and the Opportunities in China's 'Geriatric Food Industry'
    Nov 22, 2022
    Resources
    Compliance Guideline on Food for Special Medical Purpose
    View more→
    Summary and Analysis of the Approved FSMP in China
    View more→
    Administrative Measure on FSMP Registration
    View more→
    Administrative Measure on Product Formula Registration of Infant Formula Milk Powder
    View more→
    Latest Updates of China Health Food (Dietary Supplement) Regulations
    View more→
    Contact Us
    +86 571 8720 6574（CN）
    +353 1 477 3710 （EU）
    +44 20 3239 9430 （UK）
    +1 703 520 1420 (USA)
    +82 2 6347 8816 (KR)
    service@cirs-group.com
    Relevant Services
    SAMR Infant Formula Milk Powder Registration
    Nutrition Test and National Standard (GB) Compliance Test
    SAMR Health Food (Dietary Supplement) Registration/Filing in China
    Genetically Modified Microorganism Food Additive Registration in China
    Formula Review on Pre-packaged General Food
    Relevant News
    Explosive Growth of FSMP Products in the First Half of 2023 –Bringing the Total to 125 Approved Products
    Jun 28, 2023
    CIRS FAQ: Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production? Vol. 05, 2023
    May 25, 2023
    The Application Progress of Human Milk Oligosaccharides (HMOs) in China
    Mar 30, 2023
    Seven Important Changes — the Draft for General Rules on Infant Formula Food for Special Medical Purposes (GB 25596)
    Feb 27, 2023
    The Pain Points and the Opportunities in China's 'Geriatric Food Industry'
    Nov 22, 2022
    Resources
    Compliance Guideline on Food for Special Medical Purpose
    View more→
    Summary and Analysis of the Approved FSMP in China
    View more→
    Administrative Measure on FSMP Registration
    View more→
    Administrative Measure on Product Formula Registration of Infant Formula Milk Powder
    View more→
    Latest Updates of China Health Food (Dietary Supplement) Regulations
    View more→
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