技术标准为：GB19082-2009

医疗器械产品注册证-Registration Certificate for Medical Device

营业执照（具备二类医疗器械经营资质）-Business license（Qualified to operate Class II medical devices）

出口医疗物资声明-Declaration on the export of medical supplies

检测报告-Test Report

只能出口一般贸易方式直报

经营单位抬头需要二类医疗器械出口许可，查验可能需要提供资料-Export license for Class II medical devices is required. Following is information may be required for inspection

生产授权书（非工厂自有品牌需出具）-Production Authorization Letter(Non-factory own brand Needed)

采购合同-Purchase Contract

Company Introduction

Company and Prevention Products 4 17 20pptx.pdf