Medical Device Distribution in Canada - Do we need both MDEL and MDL?

M

maxximase

#1
I am a manufacturer who wants to distribute my own Class I, II, II and IV devices in Canada.

I already have MDL for the Class II, III and IV devices.

Do I also need an MDEL for the Class I device? Or am I covered because the MDL for the other devices trumps the need for an MDEL for the Class I?

Thanks for your help.
 
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Mallappa

Involved In Discussions
#3
What incase if a foreign manufacturer with no physical location in Canada, holding MDL for classs 3 medical device, can a foreign manufacturer distribute device in Canada directly? please confirm
If not, then they need distributor or importer who holds MDEL?
 

DannyK

Trusted Information Resource
#4
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
 

Mallappa

Involved In Discussions
#5
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
Hello Danny,

Manufacturer is MDL holder for its class 3 device but they are more interested to sell their device through importer or distributor. is there a way to find importers (MDEL holders) list in Health Canada website?

I am unable to find roles and responsibilities of importer or distributors with specific to class 3 medical device in Canada. It would be great help if you can share your inputs on the roles and responsibilities of importer and distributors.

Thanks in advance.

Regards,
Mallappa
 

jiligan

Involved In Discussions
#8
If the foreign manufacturer has a medical device license ( class 2, 3 or 4) from Health Canada they can distribute these medical devices in Canada.
Please PM me if you need further information.
Hi Danny, If we sell Class I devices to a licensed distributor in Canada, can a customer purchase the class I device without a prescription? Thanks!
 

DannyK

Trusted Information Resource
#9
A class 1 device does not need to be purchased with a prescription unless it is required by law to be sold with a prescription.
What is the class 1 device that you are referring to?
 

PVC Barbie

Starting to get Involved
#10
I too am looking for this information on the roles and responsibilities of the importer/distributor as its not very detailed in the guidance.

I am unable to find roles and responsibilities of importer or distributors with specific to class 3 medical device in Canada. It would be great help if you can share your inputs on the roles and responsibilities of importer and distributors.
 
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