What is the process of FDA registration?

Class I medical devices for FDA registration process is as follows:

1. Provide product information, product category determination and determine the path of application;

2. Fill out the FDA application form;

3. Sign the contract and pay the agency fee, while the U.S. agent services signed and in force;

4. Payment of U.S. dollars to the U.S. FDA Association;

5.

5. The agent submits the registration application information to the U.S. FDA for approval (business registration and product listing);

6. Registration approval is completed and an approval number is obtained;

7. The agent issues a certificate of registration;

8. The project is completed (the FDA for medical devices renews the registration at the end of each natural year from October to December for renewal of registration for the next year, which costs US$5,236 per year. The fee is 5236 USD/year).

Note: If the product is classified as Class II in the U.S. (e.g., surgical masks) you need to apply for a 510K before proceeding to the second and subsequent steps.

I hope the above helps you, if the answer is helpful to you or other friends passing by, hope to adopt and praise Yo, thank you very much~