FDA Facility Registration (FFR), also known as "FDA registration," is a regulation issued by the U.S.
Food and Drug Administration (FDA). According to this regulation, FDA requires manufacturing,
processing, packing, or holding facilities of food products (for human and animal consumption) and
dietary supplements intended for consumption in the United States, with some exceptions as
specified in 21 CFR 1.226, to register with the FDA and obtain an FFR number before importing goods
into the U.S
What is FDA registration?
FDA stands for Food And Drug Administration of the United States, part of the US Department of Health and Human Services headquartered in Washington DC, USA.
FDA standards include regulations, procedures, and guidelines that the Food and Drug Administration in the United States sets forth to monitor and inspect food products, pharmaceuticals, medical devices, and drugs. and other biological products to ensure safety and effectiveness for consumers when circulating products in the US market.
Therefore, if exporters in Cambodia want to bring their products into the US market, they must comply with FDA regulations and obtain approval for each type of product and scope of registration.
Why do you need to register FDA?
The United States Food and Drug Administration (U.S FDA) makes it mandatory for products in the FDA-managed list to register FDA before being circulated in the US, the specific products below:
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Food (cake, candy, jam, dry food...)
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Cigarettes
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Functional foods
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Dietary supplements
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Prescription or non-prescription medications
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Vaccines
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Blood transfusion
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Medical equipment
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Electromagnetic radiation equipment
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Veterinary related products
FDA registration service of CGLOBAL-KH
CGLOBAL-KH provides a full-service FDA registration for FDA regulated products (Food and Medical Devices) with a 5-step process as follows:
Step 1: Receiving FDA registered product information and business information.
Step 2: Contacting CGLOBAL USA (headquarters of CGLOBAL-KH) as the representative in the United States to register directly with the FDA: registration of production facilities, registration of codes, account registration on the Website FDA for Business.
Step 3: FDA approves with FDA code for each product that meets regulatory requirements.
Step 4: Issuing FDA certification is approved by the US Food and Drug Administration (FDA).
Step 5: Support to look up FDA-approved information for businesses on the FDA's public website and edit product labels in accordance with US laws.
FDA Certificate sample:
Why choosing CGLOBAL-KH
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CGLOBAL is a global certification network with its headquarters in California, USA, and branches across Europe (Germany, Hungary), the Asia-Pacific (Australia), Southeast Asia (Singapore, Cambodia), China, and Vietnam. The certifications issued by CGLOBAL are globally recognized and hold value worldwide.
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CGLOBAL is headquarters in the United States. It is a direct legal representative for FDA certification registration, allowing businesses to obtain FDA certification without the need for intermediary agents in the US.
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CGLOBAL Vietnam is the representative office in Vietnam for CGLOBAL. It provides direct support for FDA certification registration procedures, addresses customer inquiries and requirements in Cambodia
Contact for advice on implementation procedures and certification quotes:
CGLOBAL-KH INSPECTION AND CERTIFICATION CO., LTD.
Address: No5K, Concrete Road, Damnak Village, Sangkat Kork Khleang, Khan Sen Sok, Phnom Penh., Phnom Penh, Cambodia
Email: cambodia@cglobal.us
Tel: +855 88 697 2221