Guidance on regulating medical devices manufactured from or incorporating viable or non-viable animal tissue or their derivative(s): Appendix
Medical devices may:
- incorporate animal tissues or their derivatives as a major component (for example, heart valves, bone substitutes) or as a coating (for example, collagen, gelatin, heparin, albumin) or
- may be used during device manufacturing processes (for example, tallow derivatives used in polymer extrusion)
The following table presents animal and human tissues and derivatives used in medical devices that are or have been licensed in Canada.
| Species/tissue | Bovine | Equine | Ovine | HumanFootnote 1 | Porcine | Rooster | Shark | Shrimp | Silk (worm) | Fish |
|---|---|---|---|---|---|---|---|---|---|---|
| Amniotic membrane | yes | |||||||||
| Artery/vein | yes | |||||||||
| Blood and products (albumin, gelatin, collagen, rhAlbumin, thrombin) | yes | yes | yes | |||||||
| Bone and products (collagen, gelatin, tallow) | yes | yes | yes | |||||||
| Cartilage and chondroitin sulfate | yes | yes | ||||||||
| Comb and products (gelatin, hyaluronic acid, sodium hyaluronate) | yes | |||||||||
| Demineralized bone | yes | yes | ||||||||
| Elastin (ligament) | yes | |||||||||
| Fibroblast and products (collagen, albumin) | yes | yes | yes | |||||||
| Fat/tallow | yes | yes | ||||||||
| Fish oil | yes | |||||||||
| Heart valve and products (collagen, gelatin) | yes | yes | yes | yes | ||||||
| Heparin (intestine- or mucosa-derived) | yes | yes | ||||||||
| Hide or skin and products (collagen, gelatin, thrombin) | yes | yes | yes | yes | ||||||
| Hyaluronic acid | yes | |||||||||
| Hydroxyapatite (bone-derived) | yes | |||||||||
| Intestine and products (collagen, heparin) | yes | yes | yes | |||||||
| Meat | yes | |||||||||
| Milk casein and gelatin | yes | yes | ||||||||
| Mucosa and products (collagen, heparin, pepsin, sodium hyaluronate) | yes | yes | yes | |||||||
| Pericardium and collagen | yes | yes | yes | |||||||
| Peritoneum and collagen | yes | |||||||||
| Pepsin (mucosa-derived) | yes | |||||||||
| Placenta collagen | yes | |||||||||
| Rh demineralized bone | yes | |||||||||
| Sclera collagen | yes | |||||||||
| Serosa and collagen | yes | |||||||||
| Serum and products (albumin, rhAlbumin) | yes | yes | yes | |||||||
| Shell chitosan | yes | |||||||||
| Silk fibrin | yes | |||||||||
| Tendon collagen and gelatin | yes | yes |
- Footnote 1
-
While some licensed medical devices include human tissues and/or derivatives, requirements for those tissues are outside of the scope of this guidance.
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