FDA,CFS印尼大使馆认证（自由销售）

大 使 馆 认 证---领 事 馆 认 证---贸 促 会 认 证---香 港 商 会 认 证---香 港 海 牙认 证--原 产 地 证 书→→→

一、医疗器械FDA认证范围

从简单的治疗抑郁症的床罩到具有微芯片技术和激光手术装置的复杂的可编程起搏器。此外，医疗设备包括体外诊断产品， 例如通用实验室设备，试剂和测试试剂盒，其可以包括单克隆抗体技术。某些具有医疗应用和权利要求的电子辐射发射产品符合医疗器械的定义。示例包括诊断超声产品，x射线机和医疗激光。这些产品都需要进行医疗器械FDA认证。

264/5000 

I. Scope of FDA certification for medical Devices

From simple bedspreads for treating depression to complex programmable pacemakers with microchip technology and laser surgical devices. In addition, medical equipment includes in vitro diagnostic products, such as common laboratory equipment, reagents and test kits, which may include monoclonal antibody technology. Certain electronic emission products with medical applications and claims meet the definition of medical devices. Examples include diagnostic ultrasound products, X-ray machines, and medical lasers. These products require FDA approval for medical devices.

FDA申报

二、医疗器械必须进行FDA认证

涉及在美国使用的医疗器械生产和分销的营业所（或称为机构或设施）的业主或经营者必须每年向FDA注册。 这个过程被称为企业注册。

2. Medical devices must be approved by FDA

The owner or operator of a business (or institution or facility) involved in the manufacture and distribution of medical devices for use in the United States must register annually with the FDA. This process is called business registration.