FDA Certification:
1, the U.S. Food and Drug Administration is referred to as the FDA, FDA is the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS), one of the executive agencies established.
2. As a scientific regulatory agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical devices, and radiological products produced in or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers.
3. The agency is relevant to the life of every U.S. citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their country's products by seeking and receiving help from the FDA.
Expanded Information:
Application Process-Business Registration: Business Registration Application Form, FDA Confirmation of Release, Business Serial Number.
Product Registration:
Medical device products are divided into 3 categories with the degree of safety risk:
1, Class 1 medical device listing control
2, Class 2 market access approval (i.e., 510 (K) approval)
3, Class 3 PMA pre-entry approval 1.2.2 Entrusted agent "FDA Registration and Notification Entrustment Agreement" ( Signed by the legal representative, stamped with the company seal)
Enterprise business license:
1, business legal person code certificate, corporate registration certificate of associations, etc. (copy stamped with the official seal of the company) c) Certificate of qualification within the period of validity or certificate of production license (copy stamped with the official seal of the company) d) "Application for Registration of the FDA" (in Chinese, English, each with the official seal of the company) e) FDA Newly added requirements for the submission of other documents (if any).
2, enterprise profile (enterprise establishment time, economic performance, technical force, the main production varieties and their performance, asset status). Payment registration and listing is free of charge; 510(K), PMA need to pay according to the FDA's fees published online.
3, for registration, calculated after the charge, the FDA 60 working days to complete the registration; FDA Web site published to inform the registration, 510 (K), PMA of the FDA to send another letter of approval of access.
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