Hi everyone,
I am still not 100% clear on who needs an MDEL. A medical device manufacturer who holds Medical Device Licenses (Class II-IV) and sells directly to customers do not need an MDEL. I understand this. But what happens if this manufacturer sells its devices through other parties or distributors in Canada and in other countries? It's not selling directly but through other channels. Does this make the manufacturer a distributor now of its own devices so it has to declare itself now as a distributor and pay the establishment licensing fee?
Thanks. I appreciate this.
I am still not 100% clear on who needs an MDEL. A medical device manufacturer who holds Medical Device Licenses (Class II-IV) and sells directly to customers do not need an MDEL. I understand this. But what happens if this manufacturer sells its devices through other parties or distributors in Canada and in other countries? It's not selling directly but through other channels. Does this make the manufacturer a distributor now of its own devices so it has to declare itself now as a distributor and pay the establishment licensing fee?
Thanks. I appreciate this.

