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MDEL question - Device Establishment Licence

#1
Hi,

A company manufactures and distributes Class I devices in Canada, but it's also manufacturer of a Class II device, for which they hold an MDL. I know MDEL applies to a distributor/importer. But does the fact that the company manufactures Class II and sell devices in Canada make them MDEL-eligible? When does a manufacturer become a distributor of their own Class II devices? In this case, should Class II activities be reported on the MDEL Annual Review Application? I thought if the manufacturer holds a Class II MDL licence, they wouldn't have to report for it under MDEL. The guidance isn't clear about this.

Thank you.
 

mihzago

Quite Involved in Discussions
#2
The establishment license applies to Class I medical devices only.
For class II, III, and IV, a manufacturer must have a Medical Device License.
 
#3
MDEL applies to Class I devices. But you can also be a distributor of Class II, III and IV devices for other companies. In this case, you will also need a MDEL. My question is whether the manufacturer itself automatically becomes a distributor the moment they receive a Class II licence (MDL) and sell their device in Canada. This manufacturer is a Class I MDEL holder already, but it added a class II device which they started selling in Canada. Do they report both Class I and II on the MDEL annual review form? Can a manufacturer become a distributor of its own device? The guidance is not clear on this.

Thank you!
 

RA Guy

Involved In Discussions
#5
This is an old post so I expect the poster eventually resolved the issue and may reply. My reading of the guidance and forms is that one does not need to list class 2,3 & 4 devices on an MDEL for which the manufacturer is also the distributor in Canada. The current MDEL application form does not allow you to indicate being the manufacturer of devices in the 3 upper classifications. Having said that, the guidance does not explicitly address the poster's scenario, so contacting Health Canada would be a wise course of action. I'm sure they have seen this many times.
 

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