Legal Representation in Canada (Medical Devices)

amjadrana

Involved - Posts
#1
I have been asked by a prospective customer, whether I can be a legal representative for them. Can some one tell me whether it is a requirement in Canada?
Thank you for your inputs.
 

RA Guy

Involved In Discussions
#2
amjadrana, there is nothing akin to a mandatory requirement such as "US Authorized Representative" or for CE Marked devices an EU "Authorized Representative" for non-domestic manufacturers, but the original manufacturer and any other businesses involved in importing and distributing in Canada MAY need to comply with Establishment Licensing requirements. The link below explains who needs to comply under different scenarios.

Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) - Canada.ca

If the device is class 2-4, there is an allowance to appoint a regulatory correspondent on the device licence application forms. This appointment is not mandatory, but is a convenience to manufacturers that may want to appoint an affiliate or 3rd party for a variety of reasons.

Medical Device Application Forms - Canada.ca
 

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