Dear members
I am looking for specific regulatory requirements for secondary packages in terms of label content.
it is clear what should go on the device itself in terms on label content, yet what is the rule on any other layer of packages (except UDI which is clearly defined)? Should any level of packaging (say a carton box containing 10 devices) reflect the devics inside to the level of serial number?
Can you help providing references for US, Canada and EU?
Thank you all
I am looking for specific regulatory requirements for secondary packages in terms of label content.
it is clear what should go on the device itself in terms on label content, yet what is the rule on any other layer of packages (except UDI which is clearly defined)? Should any level of packaging (say a carton box containing 10 devices) reflect the devics inside to the level of serial number?
Can you help providing references for US, Canada and EU?
Thank you all