A
Arnthor
Dear all,
i have a situation that need some help.
My firm is located in country A and we got a sister plant in country B.
In the past, my sister plant in country B will ship the finished medical device back to country A for sterilization, inspection and export to US. On our packaging label we indicated that we are the manufacturer of this medical device.
Now my firm is going to ship the sterilization process to my sister plant in country B and my firm in country A is going to become non-manufacturing firm.
According to 21 CFR 820 definition of manufacturer,
"Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."
My firm is responsible for the design and specification developement for the medical device, so does that made us a manufacturer?
If yes? Can my firm still quoted that we are the manufacturer on the packaging label? Or i have to change the manufacturer to my sister plant in country B?
Or can I put my firm name in country A and add a statement: "Made in country B"?
Please advice.
Arnthor
i have a situation that need some help.
My firm is located in country A and we got a sister plant in country B.
In the past, my sister plant in country B will ship the finished medical device back to country A for sterilization, inspection and export to US. On our packaging label we indicated that we are the manufacturer of this medical device.
Now my firm is going to ship the sterilization process to my sister plant in country B and my firm in country A is going to become non-manufacturing firm.
According to 21 CFR 820 definition of manufacturer,
"Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions."
My firm is responsible for the design and specification developement for the medical device, so does that made us a manufacturer?
If yes? Can my firm still quoted that we are the manufacturer on the packaging label? Or i have to change the manufacturer to my sister plant in country B?
Or can I put my firm name in country A and add a statement: "Made in country B"?
Please advice.
Arnthor