出口美国的医疗产品需要经过美国联邦药监部门严格的FDA510（K）备案及GMP质量体系认证。

FDA Registration - FDA Medical Devices 医疗器械注册

The U.S. Food and Drug Administration [FDA] requires U.S. and non U.S. companies that engage in the manufacture and importing of a medical device to register its establishment with FDA 美国食品和药物管理局要求所有美国和非美国境内的生产商, 进口商都要对其医疗器械产品在FDA进行官方注册.

We offer below services: 我们为您提供如下服务:

File for and obtain your FDA Owner/Operator Number. 帮助客户提供注册申请料并获得申请人权限号码.

File for and obtain your Establishment Registration Number. 帮助客户提供注册申请资料建立账户并获得注册号

File for and obtain your device listing Number. 帮助客户提供注册申请资料并获得医疗器械列名号

FDA U.S. agent and official correspondent 为客户提供美国代理人和官方联系人服务

510(K) Administrative review and Submission service 2类医疗器械510(k)文件审核和提交 (the administrative review is not a review of your science, data, technology or predicate device selection. 文件的审核不包括对产品本身的技术参数进行核对)

Labeling review 医疗器械标签,标识审核