Hi - I am having a difficult time finding any information regarding sending IFUs for bulk packaging.
This pertains to class IIa and IIb medical devices. The product is sold directly to hospitals, surgery centers, nursing homes or distributors.
Currently, if 100 or 50 etc. devices are being sent to either of the above locations, the same number of hard copy IFUs are printed and sent along with the devices.
We have suggested that sending one copy per shipment, either on a CD or hard copy is sufficient. Additionally, I have suggested putting a sheet with the shipment that states that the IFU can be found on the website and if a paper copy (if sending CD) is needed to call the phone number provided and a hard copy will be shipped.
The push back we are receiving (and could be correct) is that if the devices are going to a distributor, there would only be one copy of the CD or hard copy in the shipping box.
I am not sure how to handle this. Also, is there a guidance somewhere that will explain how to handle sending IFUs when shipping bulk to a distributor?
Any input / suggestions / advice would be greatly appreciated.
This pertains to class IIa and IIb medical devices. The product is sold directly to hospitals, surgery centers, nursing homes or distributors.
Currently, if 100 or 50 etc. devices are being sent to either of the above locations, the same number of hard copy IFUs are printed and sent along with the devices.
We have suggested that sending one copy per shipment, either on a CD or hard copy is sufficient. Additionally, I have suggested putting a sheet with the shipment that states that the IFU can be found on the website and if a paper copy (if sending CD) is needed to call the phone number provided and a hard copy will be shipped.
The push back we are receiving (and could be correct) is that if the devices are going to a distributor, there would only be one copy of the CD or hard copy in the shipping box.
I am not sure how to handle this. Also, is there a guidance somewhere that will explain how to handle sending IFUs when shipping bulk to a distributor?
Any input / suggestions / advice would be greatly appreciated.
or that I may not have asked correctly. Have a meeting tomorrow and would like to figure this out. I did place a call to Health Canada and am hoping that they will get back to me........I will post any information I may get from them. Thank you.