Is the medical device consignment model compliant

Compliance. The current regulations clarify this approach, you only need to ensure that your records (purchases, sales) are true, complete and accurate. And provide the appropriate product qualification documents (labels, instructions, inspection reports, etc.), so it is compliant. Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software.