What is FDA certification? What is CE certification?

As the overseas epidemic intensifies, masks, goggles and other epidemic prevention supplies have gained a new round of "going overseas" demand. In order to obtain the qualification of "going overseas", companies must obtain the US FDA and EU CE certification qualifications!

1. What is FDA certification?

FDA, or Food and Drug Administration, is one of the executive agencies of the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologics, medical devices and radioactive products produced or imported into the United States, and requires all companies engaged in the production, preparation, dissemination, synthesis, assembly, processing or import and export of medical devices to register with FDA.

FDA requires all foreign manufacturers to register their production facilities and products before entering the US market, so that FDA can track and monitor the products throughout the process. Companies that violate regulations, defraud or mislead consumers will be severely punished or even prosecuted. FDA has very strict management of drugs and medical devices. It will review all experimental results provided by manufacturers, including safety data, human and animal experimental data, drug analysis data, product production records, and conduct on-site inspections of facilities. The whole process is very strict and time-consuming.

(Medical devices such as masks are registered with the FDA for one year, and are renewed every October to December)

2. What is CE certification?

CE certification is a product safety mark certification, which is regarded as a passport for manufacturers to open and enter the European market. In the EU market, the CE mark is a compulsory certification mark. Whether it is a product produced by an enterprise within the EU or a product produced in other countries, if it wants to circulate freely in the EU market, it must be affixed with the CE mark to indicate that the product complies with the basic requirements of the EU's "New Approach to Technical Harmonization and Standardization" directive. This is a mandatory requirement for products imposed by EU law.

CE certified medical device standards:

Regulation: 93/42/EEC

Regulatory description: Medical devices (MDD)