US FDA
Regulatory Introduction
The Food and Drug Administration (FDA) is one of the executive agencies established by the US government under the Department of Health and Human Services (DHHS). As a scientific regulatory agency, the responsibility of the US FDA is to ensure the safety of food (including food additives), food contact materials, medical devices, radiation products, and drugs produced or imported into the United States. The above products must be registered or certified by FDA before they can be sold in the US market, which is the highest honor and guarantee pursued by major manufacturers.
FDA Control Scope
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Food Factory FDA
Dietary supplements, bottled water, food additives, etc
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Radiation Laser FDA
Microwave ovens, X-ray equipment, sunglasses, etc
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Medical Device FDA
Masks, prescription drugs, human vaccines, etc
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Cosmetic FDA
Cosmetic color additives, nail polish, perfume, etc
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Veterinary Products FDA
Livestock feed, pet food, veterinary medicine, etc
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Tobacco products
Cigarettes, cigarette tobacco, self rolling cigarettes, smokeless tobacco, etc
The main content of FDA certification
The FDA certification generally refers to the following three types: FDA registration, FDA testing, and FDA approval.
• FDA registration: For enterprises exporting food, drugs, and medical devices to the United States, they must register with the FDA for enterprise and product listing. Otherwise, customs will not clear customs, which is a mandatory requirement.
• FDA testing: Conduct testing according to FDA regulations to see if the product meets FDA regulatory requirements. FDA testing mainly refers to safety testing of food contact materials, testing of product contact packaging, biocompatibility testing of medical products, clinical safety testing, etc.
• FDA approval: Generally, for drugs, some new products, or some high-risk products, relevant supporting materials need to be submitted to relevant departments for review. It may also involve steps such as defense or factory inspection, and ultimately result in approval for market launch or disapproval
FDA registration
FDA application for registration can also be called FDA filing. It refers to the import and export of skincare products, medical/therapeutic equipment, food products, lasers, LED lighting fixtures, and other products that need to be registered with the US Food and Drug Administration for industry and commerce, and ensure that the products comply with foreign technical standards and food safety and hygiene regulations. Some of these products must also present relevant tests in order to be successfully registered. For example, clinical medicine Class II and Class III medical/therapeutic products require 510K documents to apply for FDA registration.
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FDA Food Registration
• Validity period: Renewed every even numbered years
• Requirement: All US and non US businesses engaged in manufacturing, processing, packaging, or storing food or ingredients to be consumed in the United States must register with the US Food and Drug Administration (FDA).
• Registration steps：
1、Confirm whether the product falls within the scope of FDA food control
2、Choose a US agent
3、Prepare enterprise English information and product English information
After the successful registration of the food, the company's registration number will be obtained, and the fee includes the registration and US agent services, with a period of 3-5 working days
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FDA Medical Device Registration
• Validity period: One year, renewed annually in October
• Requirement: All enterprises engaged in the production, formulation, dissemination, synthesis, assembly, processing, or import and export of medical devices must register with the FDA.
• Registration content: including two parts: enterprise registration and product listing
Registration cycle: The FDA registration cycle is 1-2 weeks (after the registered enterprise successfully pays the annual fee to the US FDA), with the owner/operator number and product registration number first available for customs clearance. Devices that have been registered but have not yet obtained a "medical device facility registration number" can temporarily use this number as the "medical device facility registration number" for export customs declaration. Among them, Registration or FEI Number needs to wait for FDA allocation.
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FDA Cosmetic Registration
• Validity period: Permanent
• Requirement: All cosmetics sold in the United States, whether locally manufactured or imported, must comply with regulations issued by the Legal Management Committee, requiring the establishment of a voluntary cosmetic registration plan.
• Registration content: Factory registration and product registration
Factory registration: First, apply for an account, submit registration after FDA confirmation, and wait for FDA approval. The cycle is 2 weeks
Product registration: The prerequisite for product registration is to first register the factory and then submit the product ingredients. The cost of ingredient registration doubles with the ingredients.
After successful registration of cosmetics, the company registration number and CPIS product ingredient registration number will be obtained
The benefits of FDA certification
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Improve market trust：
FDA certification is a symbol of public trust in product safety and quality. Products certified by FDA can gain public trust, thereby increasing market share and sales revenue。
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Meet legal and regulatory requirements：
Many products require FDA certification to be legally sold in the US market. If the product is not certified, it may be prohibited from selling or subject to penalties such as fines。
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Improve product quality：
FDA certification requires products to meet strict standards and requirements. Therefore, certified products typically have higher quality and safety, providing a better product experience and user satisfaction。
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Enhance corporate image：
Obtaining FDA certification can demonstrate a company's professionalism and quality awareness, enhance its image and reputation. This helps companies establish better brand awareness and loyalty.
Services provided
As a professional FDA testing, FDA registration, and FDA processing service organization in China, Zhongbang Consulting has over ten years of FDA certification experience and a large customer base. It is familiar with various FDA regulatory requirements and can provide one-stop comprehensive FDA certification processing services such as FDA registration, FDA testing, FDA regulatory consulting, and FDA factory inspection guidance in the United States. We provide:
- • FDA certification for food contact materials
- • FDA certification for food, medicine, cosmetics, and daily necessities
- • FDA certification for laser products
- • 510 (K) file writing
- • Medical device FDA certification
- • FDA US Agency Services
- • FDA certification for cosmetics and daily necessities
Zhongbang is one of the earliest institutions in China to engage in compliance consulting services. It has a senior expert team composed of PhDs, Masters, and Bachelor's degrees, and has established branches in the UK, the United States, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, and other places, forming a global service network layout.
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Strong technical strength：
A strong team composed of mid to senior technical personnel with professional backgrounds in chemistry, food nutrition and health, medicine, biology, toxicology, environment, and other fields
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International service level：
A business elite team with multiple languages including English, Japanese, German, and Chinese, efficiently serving international customers
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Rich compliance experience：
With years of experience in global product and regulatory research in multiple fields, we are able to provide comprehensive and high-level compliance consulting support to various customers
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Localized service capabilities：
Having multiple branch offices in the UK, USA, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, etc., we can provide you with services nearby
Service Hotline ：400-115-9001
Zhongbang Consulting (Shandong Zhongbang North Management Consulting Co., Ltd.) focuses on product registration and compliance consulting services. With its professional technology, diverse resources, and global network, we are committed to providing regulatory consulting and environmental regulation response services for pharmaceutical, chemical, consumer goods production enterprises, and large multinational corporations. To solve the environmental, health and safety laws and regulations, product quality standards, and other issues faced by enterprises in production, sales, and global trade processes.
Accumulated Customers
15,000+
Distributed in 35 countries and regions
12year
Industry experience
260+
Senior expert team
15+
Subsidiaries
300+
Collaboration Cases
Brand Cases
The choices and trust of over 15000 customers are the driving force for Zhongbang to continuously improve its services. We are willing to grow together with these excellent enterprises
Service Hotline：400-115-9001
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Consultation
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