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Can an individual apply for an MDEL in Canada, as an establishment?

fialor

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#1
Hi All,
I have come up against a unique situation for a client in Canada (unique for me as this is the first time I am experiencing this).

Can an individual apply for an MDEL in Canada, as an establishment?
I have done quite a lot of health canada registrations in the past but have not come across an individual acting as the importer/distributor and therefore requiring a MDEL?

Your feedback would be greatly appreciated.
Thank you
Fialor
 

RA Guy

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#2
I don't see why not, but you could call or email Health Canada to clarify. Depending on the nature of the device, being personally liable for importation and distribution may not be a wise approach.
 

fialor

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#3
RA Guy,
That is my thinking at present. However the language in the regulations leave me in two minds:
the regulation defines a person to include a partnership and an association. But in the MDEL application guidelines, reading the use of the word establishment makes me take pause on whether the natural person can be within the definition of the person in the regulation?
 

RA Guy

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#4
The Food and Drug Act defines "person" as follows:
person means an individual or an organization as defined in section 2 of the Criminal Code; (personne)

https://laws-lois.justice.gc.ca/eng/acts/F-27/page-1.html#h-2

I am not a lawyer, but I think the issue for your client here is not whether Health Canada would permit a person to register as an establishment, but whether it is wise to take personal liability for the devices vs. limiting liability through a company. The former can easily be clarified by contacting the establishement registration authorities, the latter may require professional legal advice on the liability risks.
 
#5
I don't think an individual can apply.

Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) - Canada.ca

Generally, "persons" are classified as natural persons (individuals), corporations, partnerships and associations. In this case, it appears as though person is used to include partnerships and associations, as distinct from corporations, as applicants. The definition in the link above refers to the regulations' definition of "person" (as opposed to the more general statute) and refers only to associations and partnerships, not individuals.

This is corroborated by the application form, itself, which may be impossible for a natural person to fully complete. And, as the fee is non-refundable, the prior posters suggestion to contact health Canada is echoed in the form instructions.

Not definitive by any means but it seems that individuals need not apply for MDELs.

EDIT: and insofar as the question of whether an individual SHOULD apply for an MDEL, assuming for the sake of argument that individuals are eligible to apply, if the costs of setting up a limited liability entity such as a corporation significantly impact the business model, then the margin is too thin or the venture is underfunded.
 
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#6
Look up the definition of "Establishment", most likely a corporation (Inc. or Ltd) depending on the business model. This is more of a legal issue than a regulatory one. This sounds like a sole proprietorship type of business model where the person will assume 100% liability. I have never seen this before either.
 

fialor

Involved In Discussions
#7
Hi All,
Just a quick update.
I finally got a call back from the Health Canada regarding the question above and the answer is...

YES! an individual can apply to be an Importer and apply for an Establishment License.

I have emailed a confirmation of the phone call response together with a couple of other questions, and once I receive a response to those questions, I will share those as well.
 


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