US FDA (Food and Drug Administration) certification Class II or III medical devices Cosmetics and daily necessitiesDescription
1.FDA inspection of food materials(Food Contact Materials (FCM));
2.Food FDA test;
3.FDA inspection of medical devices;
4. Cosmetics FDA test;
5, FDA testing of drugs and biological products.
It can be understood that FDA testing generally targets these types of products:
1. Class II or III medical devices;
2. Cosmetics and daily necessities;
3. Food contact materials;
FDA registration is generally divided into:
1. Cosmetics
2. LED and laser products
3. Medical devices
4. Food
5. Drugs.
FDA certification is a collective name for FDA testing and FDA registration.
Both of these can be called FDA certification.
FDA certification is just a colloquial term.
Does FDA registration necessarily require a U.S. agent?
Yes, Chinese applicants must appoint an American citizen (company / community) as their agent when registering with the FDA. This agent is responsible for the process services located in the United States and is the medium for contacting the FDA with the applicant.
