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

[maxximase]

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.

 

[DannyK]

If you are distributing class I devices in Canada you need a medical device establishment license.

 

[Mallappa]

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]

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]

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

 

[Edward Reesor]

Yes, in order to sell your Class I devices, even to distributors, you will require a MDEL.

 

[DannyK]

The link to the MDEL is https://health-products.canada.ca/mdel-leim/index-eng.jsp

 

[jiligan]

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]

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]

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.