The fee for each export certificate issued from CDRH is $175.00 for the first certificate and $85.00 for each subsequent certificate from the same request. Manufacturers of devices not exported from the U.S., as described in section 801(e)(4)(F) of the FD&C Act, may not receive export certificates. For more information about requesting a CFG-NE, see Devices not Exported from the United States page. Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE).The CDRH Exports Team also processes other documents for medical devices, including: Certificate for Exportability Under Section 802 of the FD&C Act.Certificate of Exportability Under Section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).Certificate to Foreign Government (CFG).CDRH issues four types of export certificates: To obtain an export certificate, a request must be submitted and CDRH will provide approval or denial of the request. The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates for medical devices.
or cannot be legally marketed in the U.S. The marketing status indicates that the device may be legally marketed in the U.S. The requirements for exporting medical devices depend on the marketing status of the device. The export certificate certifies in writing that the exported device, including radiation emitting electronic products that are medical devices, meets certain specified requirements. An export certificate is a document prepared by the FDA containing information about a product's regulatory or marketing status in the U.S. The Export Reform and Enhancement Act of 1996 authorized the FDA to issue an export certificate and charge a fee for each certification that is issued within 20 working days. CDRH Export Certificate Validation (CECV)Įstablishments exporting devices from the United States (U.S.) are often asked by foreign customers or foreign governments to supply proof of the devices’ regulatory or marketing status as regulated by the Food and Drug Administration (FDA).
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