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What is FDA 510(k)? Learn about the FDA 510(k) certification
The United States is one of the largest medical device markets globally. To be authorized to market medical devices in this industry, manufacturers must comply with the regulations of the Food and Drug Administration (FDA). One of the crucial regulations is the FDA 510(k) certification. So, what is FDA 510(k)? What are the regulations associated […]
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What is a FDA medical device? Overview of Medical Device Classification
Medical devices are among the products that directly impact the health and well-being of users. Therefore, ensuring the quality and safety of medical devices is of utmost importance.In the United States, the Food and Drug Administration (FDA) is the authorized agency responsible for managing and overseeing the quality of medical devices. The FDA has established […]
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What is GMP? The requirements and deployment processes of GMP
During the product manufacturing process, ensuring quality is a crucial factor. To achieve this, manufacturing businesses need to adhere to quality standards. One of the most important standards is GMP – Good Manufacturing Practice. So, what is GMP? How about the requirements and deployment processes of GMP? Let’s explore in the following article with GOL! […]
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What is HACCP? The seven principles of HACCP
Food safety is a crucial concern for human health. In recent years, the issue of food safety has gained increasing attention and emphasis. To ensure food safety, businesses involved in food production and processing need to implement food safety management systems. One of the most common food safety management systems today is HACCP. In this […]
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What is FDA cosmetics? How to get registration of FDA cosmetics?
The United States is a vast and lucrative cosmetics market with an annual consumption potential reaching hundreds of billions of dollars. To penetrate this market successfully, cosmetics businesses must adhere to the stringent regulations set by the U.S. Food and Drug Administration (FDA). Among these, FDA registration is a mandatory requirement for all cosmetic products […]
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Exporting food to the United States – Things to keep in mind
The US food market is one of the largest and most stringent markets globally. For global businesses to export food to this market, they need to be well-versed in the strict regulations and standards set by the US Food and Drug Administration (FDA). In this article on Exporting food to the United States – Things […]
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Top 9 World-Class FDA Registration Service Companies
The American market stands as a pivotal export destination for numerous countries globally. To export products into this market requires businesses to secure the coveted FDA certification, a mandatory prerequisite set by the United States Food and Drug Administration (FDA).The process of FDA registration is intricate and demands a significant amount of time. Therefore, many […]
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How to obtain FDA registration: A step-by-step guide
FDA registration is mandatory for all companies involved in the manufacturing, processing, packaging, or distribution of food, drugs, medical devices, or cosmetics in the United States. Registering with the FDA can be a complex and time-consuming process. However, it is essential to ensure that your products comply with FDA regulations and are safe for consumers. […]
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What is the FDA? FDA Regulations, and Guidances
You’ve likely encountered the term FDA, especially when investigating products that comply with U.S. quality standards. So, what is FDA, and what specific requirements do products meeting FDA standards have? Let’s delve deeper into this with GOL in the following article! 1. What is the FDA? FDA stands for the Food and Drug Administration, is […]
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Selling Beauty Products? FDA Approval Explained
Learn about the FDA approval process for selling beauty products and ensure compliance with regulations.
