Medical Device Implant Registration Cards required by SOR/98-282

D

DeviceComply

#1
Hello All,

My understanding of the Implant Registration Card (required by SOR/98-282 Sections 66 et al) is that they are required for Class 3 and 4 devices. Seeing that we have recently received approval for a Class 4, our understanding is that two copies of this card are to be provided within the packaging for each product. The HCP and patient fill out one copy and send it back to the manufacturer's Quality department. The reason for sending to the Quality department is so that the manufacturer can communicate safety issues and corrective actions directly to that patient. Is this accurate? Are patients/HCPs actually doing this? How do they send it back to the manufacturer - is postage paid for? This is something very new for us.

Any and all advice/direction is greatly appreciated.

Thank you
 
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sreenu927

Quite Involved in Discussions
#3
Hi,

1. Usually, the reason for sending back one implant registration card is for traceability purposes (Identification and Tracking of implants).

2. Are patients/HCPs doing this?
As the Section 67 (1) of SOR 98-2002 states about this - so this must be done by the Health care Facility representative.
If this is not done, during the Health Canada ISO 13485 Audit, it could be a potential observation at the manufacturer's site, if you fail to show the evidence.

As of my understanding the implant process will be performed by the Health Care Professional at their facility in the presence of Manufacturer's representative. So soon after the implant process, the HCP can pass the card to Mfg rep; if not HCP can send via Post. Regarding your question of bearing postage expenses depends on the agreement/understanding between you (Mfg) and HCP.

Hope this helps!

Regards,
Sreenu
 
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