Health Canada is the governing body in Canada for medical devices approval similar to the FDA in USA. Medical Device License(MDL) is required before device could be sold there.
Looks like Anteris has obtained approval for the ViV treatment in Canada via the Special Access program
https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/#hist
Not sure if this program will also allow other non-Canadian patients to fix their deteriorating implant. I am also wondering whether this Special Access program provides a pathway leading to MDL approval in Canada?
Not advice, DYOR
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