According to different risk levels, FDA divides medical devices into three categories (I, II, III), with category III having the highest risk level. The FDA clearly stipulates its product classification and management requirements for each medical device. There are more than 1,700 types in the FDA medical device product catalog. Any medical device that wants to enter the U.S. market must first clarify the product classification and management requirements for applying for marketing.

After clarifying the above information, the company can begin to prepare relevant application materials and apply to the FDA according to certain procedures to obtain approval.

For any product, the enterprise needs to carry out enterprise registration (Registration) and product listing (Listing).

For Class I products (about 47%), General Control is implemented. Most products only need to be registered, listed and implemented GMP regulations, and the products can enter the US market (including A very small number of products are exempted from GMP, and a very small number of reserved products need to submit a 510(K) application to the FDA (PMN (Premarket Notification));

For Class II products (about 46%), the implementation is Special Control: after the enterprise is registered and listed, it still needs to implement GMP and submit a 510(K) application (very few products are 510(K) exempt);

For Class III products (accounting for about 7), pre-market licensing is implemented. After registration and listing, companies must implement GMP and submit a PMA (Premarket Application) application to the FDA (some Class III products are still PMN).