半成品供应商属于Component Manufacturer吗? 要做FDA注册吗？

我太南南南了

最近遇到一个比较纠结的问题：提供半成品的供应商（Wound dressing半成品，购买回来后自己工厂做包装及灭菌）属于Component Manufacturer还是Contract Manufacturer？半成品供应商是否需要做Establishment Registration呢？


纠结的点是：
（a）免于注册的企业类型包括：
Component Manufacturer
– Provides raw materials or components used in device manufacture or assembly (not ready for use)
– Provides only to finished device manufacturer
（b）必须要注册的企业包括：
Contract Manufacturer and Contract Sterilizer
– Sterilizes, or otherwise makes a device for or on behalf of a specification developer or any other person
– Arranges manufacturing for another establishment


觉得两种都有点符合，所以拿不准。另外看了成品器械的定义（Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized）. 觉得半成品也是满足capable of functioning了，是不是也可以看作成品器械了呢？


太纠结了。。。。有没有大佬可以答疑解惑呀

小瑾

蹲，但感觉更像Contract Manufacturer，毕竟你们不做产品的具体生产，到你们已经是完整的产品结构，已经可以实现产品功能了。（个人理解是关键工序的OEM了，FDA Registration 需要提交吧）

ch192925

委托生产时直接给你提供可销售的成品

胜利者

主要