Background of the Project

In the world, including Japan, Singapore, Mexico, Costa Rica, Australia and other countries and regions, the medical device products listed in the United States have a general recognition, this recognition is not only reflected in the medical device products that have been listed in the United States can obtain the trust of consumers in these countries, to facilitate the development of the market, these countries also often have special FDA-equivalent or simplified certification pathways for product access. For manufacturers, this not only means saving registration costs, but also shortens the registration cycle and enables them to enter the national market more quickly.

On December 29, 2022, the Consolidated Appropriations Act of 2023 was signed into law, which amends Section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act. This amendment provides a more convenient way for manufacturers of non-US exported device to apply for a US Free sale certificate, including a non-US exported device certificate, known as the CFG-NE certificate (Certificate to Foreign Government for Device Not Exported from the United States).

Conditions for applying for FDA CFG-NE

Each device shown on the certificate was manufactured by a facility located outside the United States; 2. Each entity appearing on the certificate is currently registered under Section 510 of the FD&C Act; 3. According to the requirements of the Act, each medical device appearing on the certificate needs to be listed; 4. Each device identified herein is authorized for sale in the United States and:

• is the subject of a premarket notification under section 510(k) of the FD&C Act; or

• is the subject of a premarket approval application (PMA) approved under Section 515(d) of the FD&C Act; or

• is the subject of a humanitarian device exemption approved under section 520(m) of the FD&C Act; or

• A De Novo classification request has been obtained under section 513(f)(2) of the FD&C Act; or

• Commercially distributed before 28 May 1976; or

• no need to submit premarket report pursuant to section 510 (l) or (m) of the FD&C Act;

5. Each device was imported or offered for report into the United States;

6. Each device identified is not subject of an open import alert, recall, seizure, injunction, or the subject of any other open enforcement action initiated by the FDA;

7. Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified;

8. The requesting establishment and all establishments involved in the manufacturing process are operating in substantial compliance with the current Good Manufacturing Practices Requirements (Section 520(f) of the FD&C Act).

Information required to apply for CFG-NE

SUNGO will require the enterprise to fill out an application form, which mainly includes the following information:

1) Basic information of the establishment;

2) the DUNS number of the establishment;

3) Device list information, including product code, product name, etc.

At present, SUNGO has assisted the manufacturer to complete the first US FDA CFG-NE certificate application, which took only two days to receive the US approval! 

Note: Starting from January 2, 2024, the US FDA has fully implemented the electronic version of the CFG-NE certificate, and no longer issues the paper original.