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 Learn About US FDA And European CE

Learn About US FDA And European CE

There must be a lot of people who always wonder why they don't understand the many terms that are attached to the products or the certifications attached to the products they use. And moreover, on certain websites or articles that mention but you don't understand, US FDA and European CE are also among the definitions that many people want to know. Let's learn about them right here.

What is FDA?

– FDA is a familiar term that stands for the phrase “US Food and Drug Administration”. Translated into Vietnamese, it means "US Food & Drug Administration"

What mission does the FDA work with? 

“Protecting and Promoting Your Health”, you can understand as “Protecting and promoting health”

– FDA has a responsibility to protect public health by many strict regulations for technology products. have a direct effect on human and animal health (e.g. cell and gene therapies, vaccines); medical equipment; food and fodder; cosmetics; and all products that emit radiation, Laser…

But not all of these products go through FDA experts' safety and effectiveness testing before a product is marketed. In many cases, the FDA will focus on the product after it has been on the market.

You've probably seen the term "FDA APPROVED!" – “FDA ISSUED CERTIFICATE”… on the website or on the products of a certain company, or in the advertising / product promotion programs about the treatment of a certain problem.

FDA's Scope 

FDA is responsible for protecting and promoting public health through the regulation and oversight of the safety of food, tobacco products, dietary supplements, prescription and non-prescription drugs. prescription drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation from transmitters, and veterinary products.

FDA also enforces other provisions of the law, notably Section 361 of the Public Health Services Act and its accompanying regulations, many of which do not directly relate to food or drugs. These include sanitary requirements for inter-departmental travel and disease control on various products.

What is CE certification? 

The CE Mark or CE Mark is a symbol to demonstrate the commitment of manufacturers that their products meet the requirements of European Union legislation.

The letter CE stands for Comformance de Europe in French. According to the regulations of the European Union, electrical and electronic products (except for special ones) must have CE marking to be circulated on the European market (28 countries) - this can be considered a " commercial passport".

CE

On all foreign-origin electrical and electronic products imported into Vietnam, consumers often see the CE mark (on the product and/or on the package). So what is CE marking? What does it mean for consumers? What does it have to do with the supplier (manufacturer, importer…)?

The CE mark printed on the product means that the product meets the minimum safety requirements according to European regulations, and is accepted in most countries around the world.

CE certification is required for goods and is considered as a commercial passport to the European market (and also some other countries outside Europe such as the US, Malaysia, Australia, Iran...). Without CE certification, the goods will be seized by the Customs of the importing country and not allowed to circulate in their country.

A product that meets CE standards means that this product is safe for users. Any technological product, when manufactured in accordance with CE standards, means that the stages of the process reach the level of strict inspection, so that there are no unintended errors. Therefore, the product has better quality and the design will also be more beautiful.

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