We're putting together a sample box of some products. These include an OTC Class II medical device and various consumer products that we also sell on their own. We're planning on adding some band-aids which are Class I in the US and Canada. The band-aids are being obtained from a supplier and we're just adding them to this sample box as a sort of give-away and fun thing to add into the box when consumers order the product on-line.
My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?
My question is do we need to register the Class I with Health Canada? We already have an MDALL for the Class II, but with the addition of the Class I, I'm not sure what we need to take of with Health Canada. And, do we have to update our 13485 certificate as we are adding a Class I as a give-away in our sample boxes? Would our Notified Body need to be made aware now that we are adding a Class I?