International Business Advisory Services

FDA 申請・登録

Food and Drug Administration "FDA"

Food / Beverage | Food contact substances | Food additives, Coloring agents, etc. | Medical device | Cosmetics | Pharmaceuticals
Radiation-emitting Products | Veterinary Related Products | US Agent

Food, beverages, cosmetics, medical equipment, pharmaceuticals, radiation equipment and veterinary related products sold in the United States are under the jurisdiction of the FDA. In order to sell these products in the United States, it is necessary to properly notify / register with the FDA or obtain permission from the FDA in advance. In the absence of proper procedures, customs clearance at US Customs will be overdue or refused and will be detained at the port of entry or other facilities. Bringing products into the United States or selling without proper notification, registration, or permission is illegal.

In addition, we can also support patent application and acquisition in the US of your products.

Food / Beverage

  • Food Facility Registration
    All facilities involved in the manufacturing, processing, packaging and storage of foods, beverages, supplements etc. consumed in the US must be registered with the FDA.
  • Nutritional analysis and Labeling
    Foods sold in the US need to have a label according to FDA regulations including the nutritional analysis.

    We will help you with nutritional analysis, preparation of labels and reviewing labels.
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Food contact substance

  • Foods sold in the United States, instruments used in the process of manufacturing foods, utensils for cooking, tableware, packaging, etc., that are in direct contact with food are regulated by the FDA. Depending on the constituent substances used for food contact substances, it may be necessary to obtain approval/registration.
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Food Additives, Coloring Agents, etc.

  • Depending on constituent substances, application, notification and registration may be necessary. We will consult with you on each case if the usage of the food additive and coloring agent is already permitted to use. If it is necessary to obtain approval, we will help you with the process.

    FDA Link on Food Products:
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Medical Devices

It is necessary to obtain clearance/approval and register your facilities and devices with the FDA prior to selling medical devices in the United States. In order to acquire permission from the FDA and register, first we can assist in identifying the classification and product code of the device. After determining the classification, we will move on to the investigation of the product code and preparation of the necessary application if clearance/approval is required. Once clearance/approval for the product is obtained, appropriate registrations will be considered. If clearance/approval is deemed unnecessary for the type of device, then we will proceed to only register the facility and product. In each case, we will consult with you how to navigate the most appropriate path and support you until registration is complete.

FDA Link on Medical Devices:

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The FDA’s Cosmetic Registration Program is a voluntary reporting system for use by manufacturers, packers, and distributors of cosmetic products that are commercially distributed in the United States. Manufacturers are not required to register cosmetics, but cosmetic ingredients are required to be safe for use. In addition to the FDA’s regulations, there are other federal and state regulations, including those from the EPA (Environment Protection Agency), California Proposition 65 and other states regulations concerning cosmetics ingredients. Labeling on cosmetics are not permitted to bear labeling similar to drugs that state a diagnosis, treatment, cure, or prevention, etc. of diseases and conditions. At EGS, we can help you with voluntary registrations for cosmetics with the FDA, check ingredients with all applicable regulations and review your labels to ensure compliance with the relevant regulations.

FDA Link to Cosmetics:

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Our professional consultants have expertise in various fields of clinical research. Since the reliability and consistency of clinical trial data are very important elements when submitting clinical trial results to the FDA, the selection of institutions that perform excellent clinical research is key. International clinical research standards are defined by Good Clinical Practice (GCP). GCP defines the roles and responsibilities of sponsors, researchers, ethics officers and supervisors in how clinical trials are implemented. Outstanding clinical research is achieved by observing all these criteria. We can help you select institutions that can do excellent clinical research with all such elements based on the specifications of your pharmaceutical product.

FDA Pharmaceutical link:

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Radiation-Emitting Device and Veterinary related products

We also provide consultation about radiation-emitting device and veterinary related products.

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US Agent

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