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  • Are all "personal care products" regulated as cosmetics?
    A
    People often use the term "personal care products" to refer to the various items we commonly find in the health and beauty departments of pharmaceuticals and department stores. Depending on the law, these products may fall into many different categories. It depends on the circumstances.
    CosmeticFDA cosmetics
    Dec. 19th, 2023
  • If cosmetics are not approved by the FDA, how can they be regulated?
    A
    FDA regulated does not mean FDA approved. The FDA does not have the legal authority to approve cosmetics before they are marketed, although the FDA does approve the color additives used in them (with the exception of coal tar hair dye).
    FDA
    Dec. 19th, 2023
  • What are the FDA regulations on food contact materials?
    A
    The most important FDA regulation for food contact materials is 21 CFR Part 177-2003, Polymer Substances. Other requirements include 21CFR Part 175-2003, Adhesives and Coating Materials class; 21CFR Part 176-2003, Paper and board products 21CFR Part178-2003, Food additives: Additives, production AIDS and disinfection and fungicides.
    FoodFDA
    Jul. 25th, 2023
  • Is there a certificate of FDA registration?
    A
    In fact, there is no certificate for FDA registration, the product will be registered with the FDA, will receive a registration number, FDA will send the applicant a letter (signed by the FDA administrator), but there is no FDA certificate. The certificate we usually see is issued to the manufacturer by the intermediary agent (Registration agent) to pr
    FoodFDA
    Jul. 21th, 2023
  • Is FDA registration different from CE certification?
    A
    The model of his certification is different from the CE certification of product testing + report certificate model, the FDA registration actually uses the integrity declaration model, that is, you are responsible for your own products meet the relevant standards and safety requirements, and register on the federal website in the United States, if the
    Medical DevicesFDA
    Jul. 21th, 2023
  • Does FDA registration necessarily require a U.S. agent
    A
    Yes, a business must appoint a U.S. citizen (company/association) as its agent when registering with the FDA. This agent is responsible for conducting the process services located in the United States and is the medium for contacting the FDA and the applicant.
    Jul. 21th, 2023
  • Does the FDA require designated certified laboratory testing?
    A
    The FDA is an enforcement agency, not a service agency. If someone says they are a certified laboratory under the FDA, then he is misleading consumers at the very least, because the FDA does not have a public service certification body and laboratory, nor does it have a so-called "designated laboratory."
    Jul. 21th, 2023
  • Which agency issues FDA certificates?
    A
    FDA certification is issued directly by the U.S. Food and Drug Administration (FDA). The FDA is an agency of the U.S. federal government responsible for regulating the safety and effectiveness of food, drugs, medical devices, and other products, including approving the marketing of new products and monitoring the quality and safety of products already
    Jul. 21th, 2023
  • What does NDC code mean?
    A
    An NDC code is an 11-digit identifier assigned by the FDA to identify a drug and its packaging. The NDC stands for National DrugCode, the "National DrugCode," which was introduced by the FDA in 1969. The NDC code consists of three parts, which are the drug manufacturer, the description of the drug and the package, and the package specification and quan
    FDAFDA NDC
    May. 15th, 2021
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Zhongbang Consulting (Shandong Zhongbang North Management Consulting Co., LTD.) focuses on product registration and compliance consulting services. With its professional technology, multi-party resources and global network, it is committed to providing regulatory consulting and environmental protection regulatory response services for pharmaceutical and chemical enterprises, consumer goods manufacturers and large multinational corporations. To solve the environmental health and safety laws and regulations, product quality standards and other problems faced by enterprises in the process of production, sales and global trade. Including chemical raw materials, fine chemicals (pesticides, coatings, dyes, medicine, etc.), intermediates, auxiliaries, food, medical equipment, etc. The service network covers China, the European Union, the United States, Japan and South Korea, Southeast Asia and other regions.
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