K
Hi all,
Let's say I use the symbol for irradiation sterilization on the label of a sterile implant. Do I have to print the symbol in the instrucitons for use?
My current thinking is that 13.6(a) stipulates that all information (with a few exceptions) that is printed on the label also needs to be included in the IFU. This would include the symbols, right?
Do you have any input on this?
/K
Let's say I use the symbol for irradiation sterilization on the label of a sterile implant. Do I have to print the symbol in the instrucitons for use?
My current thinking is that 13.6(a) stipulates that all information (with a few exceptions) that is printed on the label also needs to be included in the IFU. This would include the symbols, right?
Do you have any input on this?
/K
CANADA does not recognize or accept the use of symbols without package insert or leaflet defining those symbols! Also only Quebec province, require French language.