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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
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