Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community,

I would like to ask if anyone knows if the MCE for the Class I MD issued in Canada may contain the list of the class I MD? In case of class II or above to MCE it is easier , because the manufacturer may count with MDL, but how does the MCE look like in case of Class I MD, which only requires MDEL (I need MCE to contain the list of products)? I checked the Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097) , but the information is not 100% clear to me.  

Thank you in advance for all replies.

Hi Anon,

the certificate with MDEL licence you will received from Health Canada will just list the class of device (I, II, II or IV) and if you are distributor, Importer or Manufacturer. There no reference to the name or model of the product. This is the information that is also available in https://health-products.canada.ca/mdel-leim/

Best Regards,

------------------------------
Stephane Berger
La Ciotat
France
------------------------------

Original Message:
Sent: 27-Sep-2022 04:51
From: Anonymous Member
Subject: Manufacturer's Certificate to Export - Class I MD

This message was posted by a user wishing to remain anonymous

Dear Community,

I would like to ask if anyone knows if the MCE for the Class I MD issued in Canada may contain the list of the class I MD? In case of class II or above to MCE it is easier , because the manufacturer may count with MDL, but how does the MCE look like in case of Class I MD, which only requires MDEL (I need MCE to contain the list of products)? I checked the Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097) , but the information is not 100% clear to me.

Thank you in advance for all replies.

Dear Anon, 

it is also important to know that MDEL must be renewed yearly before 1st April.  The validity of MDEL you can check using the link sent already from Stephane. It is sufficient when your local partner has already a MDEL and you do not need to apply for it in such case. 

Regards,

------------------------------
Agnieszka Fronczak
Regulatory Affairs Manager
Neu-Ulm
Germany
------------------------------

Original Message:
Sent: 27-Sep-2022 04:51
From: Anonymous Member
Subject: Manufacturer's Certificate to Export - Class I MD

This message was posted by a user wishing to remain anonymous

Dear Community,

I would like to ask if anyone knows if the MCE for the Class I MD issued in Canada may contain the list of the class I MD? In case of class II or above to MCE it is easier , because the manufacturer may count with MDL, but how does the MCE look like in case of Class I MD, which only requires MDEL (I need MCE to contain the list of products)? I checked the Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097) , but the information is not 100% clear to me.

Thank you in advance for all replies.