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FDA CFG自由销售证书

The Export Reform and Enhancement Act of 1996 authorized the Food and Drug Administration (FDA) to issue an export certificate that certifies in writing that the exported device, including radiation emitting electronic products that are medical devices, meets certain specified requirements. The Center for Devices and Radiological Health (CDRH) is responsible for issuing those certificates for medical devices. There are four types of certificates, which are issued based on the marketing status of the device:

美国1996年的<出口改革和加强法>授权美国食品药品监督管理局FDA签发出口证书，以书面形式证明出口的医疗器械，包括作为医疗器械的辐射电子产品，符合某些特定要求。医疗器械和放射卫生中心(CDRH)负责颁发相关出口证书。根据销售状态，可签发四种类型的出口证书并收取证书费：

Certificate to Foreign Government自由销售证书(CFG, CFG-NE)
Certificate of Exportability 801(e)(1) 出口商品证书
Certificate of Exportability 802出口商品证书
Non-Clinical Research Use Only Certificate非临床研究专用证书

最常见的自由销售证书CFG包含：

CFG: Certificate to Foreign Government 针对先出口美国，再从美国出口到其他国家

CFG-NE: Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE)针对不经过美国，直接出口到非美国的其他国家

IRC可提供FDA CFG证书申请。

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