The difference between CE and FDA certificate
The difference between CE and FDA certificate for medical device
1. Different nature
CE certification is a safety certification mark; FDA is an implementing agency.
CE stands for European Unification (CONFORMITE EUROPEENNE). The "CE" mark is a safety certification mark and is regarded as a passport for manufacturers to open and enter the European market.
The United States Food and Drug Administration (Food and Drug Administration) is abbreviated as FDA, which is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).
2. Different responsibilities
All products with the "CE" logo can be sold domestically in the EU members 636f7079e799bee5baa6e997aee7ad9431333431373335, and do not need to meet the requirements of each member state, thus achieving the free circulation of goods within the EU member states.
As a scientific management agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radioactive products produced or imported in the United States.