21 CFR 807.40

中国医疗器械企业的 FDA 美国代理人

向美国出口产品的中国医疗器械企业必须向 FDA 注册，并指定一名位于美国境内的美国代理人（21 CFR 807.40）。在 2025-10 to 2026-09 的 12 个月内，FDA 拒绝了来自中国的 2,749 个进口条目，并有 85 项 FDA 进口警示列有来自中国的企业。

中国的 FDA 数据

数据来自 FDA 公开数据，检索日期 2026-10-21。召回数量按召回企业所在国家统计。

被拒绝的进口条目	2,749
涉及注册或列名问题的拒绝	NOT LISTED-118 · 388 FRNMFGREG-3280 · 279

代码		数量
80	General Hospital/Personal Use	133

代码	数量
TP NO PMTA-3842 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C …	415
MELAMINE-3421 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the…	401
TP NO SE-3843 This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C A…	396
NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information…	388
FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i…	279

至少列有一家中国企业的进口警示：85 项。近期更新：

Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
Import Alert 45-06: Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts
Import Alert 99-05: Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
Import Alert 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides

208 (Class II: 175, Class I: 31, Class III: 1, Not Yet Classified: 1)

近期召回原因:

2026-10 Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
2026-10 Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are …
2026-09 The 6Fr suction catheter could not pass through the samples smoothly.

所有生产、制备、繁殖、配制或加工进口至美国的医疗器械的外国企业，都必须向 FDA 注册、列出其器械，并指定唯一的美国代理人。注册每年在 10 月 1 日至 12 月 31 日之间更新，且必须先缴纳 FDA 的年度企业费用。

我们担任您的美国代理人，用您的语言准备注册资料供贵公司的负责人提交，在 FDA 要求时确认指定，并每天早晨查看 FDA 公开记录中与贵公司有关的内容。价格从每年 $990 起。

来源

独立的私营服务。与美国 FDA 无隶属关系。不构成法律意见。