A
Dear all,
My firm is a maunfacturer of medical device for US market. Recently my management is trying to outsource part of the production line to an contract manufacturer. This process is rather complicated and I need some advice.
My firm had a sister plant located in a another country and this sister plant will manufactured a WIP (Work In Process) part of a medical device. Then it will ship to a contract manufacturer to completed the entire medical device.
After completion of the finished medical device, the contract manufacturer will shipped the finished device back to my firm for sterilization and final inspection.
My firm sister plant was registered under my firm US FDA establishment listing.
So my question is, does my firm need to register the contract manufacturer under by my firm establishment listing? Or they have to register with US FDA themselves?
Please advice.
Arnthor
My firm is a maunfacturer of medical device for US market. Recently my management is trying to outsource part of the production line to an contract manufacturer. This process is rather complicated and I need some advice.
My firm had a sister plant located in a another country and this sister plant will manufactured a WIP (Work In Process) part of a medical device. Then it will ship to a contract manufacturer to completed the entire medical device.
After completion of the finished medical device, the contract manufacturer will shipped the finished device back to my firm for sterilization and final inspection.
My firm sister plant was registered under my firm US FDA establishment listing.
So my question is, does my firm need to register the contract manufacturer under by my firm establishment listing? Or they have to register with US FDA themselves?
Please advice.
Arnthor