Requirements for medical FDA certification
Writer： admin Time：2020-07-17 16:38 Browse：℃
I.Requirements for medical FDA certification:
The FDA stipulates that foreign medical devices,food,alcohol,drugs and other factories must be registered before entering the United States,and a U.S.agent must be appointed to handle emergencies and daily communications.
A U.S.agent is one who is designated as a registered agent by a foreign factory in the United States or has a business location in the United States for FDA registration purposes.A U.S.agent cannot simply be an email address,a voice call,or a place where the personal address of a foreign factory agent does not exist.
The U.S.agent represents a foreign factory,and FDA will treat the REPRESENTATIONS made by the U.S.agent as statements made by the foreign factory,and will consider the information or documents provided to the U.S.agent to be equivalent to the information or documents provided to the foreign factory.
The manufacturer may designate only one person as a U.S.agent for an FDA plant registration.The designation of a U.S.agent for the purpose of factory registration does not preclude the factory from designating multiple other agents(such as foreign suppliers)for other commercial purposes.The company's business activities in the United States are not required to be conducted through an agent designated by this registration.
Ii.How to register medical products with FDA
***Step:Determine product classification
According to CFR TITLE 21,part 862-892,most medical devices can be classified according to this classification code.FDA classification code
Step 2:Select a US AGENT
Step 3:Prepare for registration
1.Directly register the factory and list the products;The 510(k)file needs to be prepared for category 2 products.
Step 4:Submit 510(k)documents to FDA for document review
Step 5:Register the factory and list the products
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