Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both?

gunnyshore

Starting to get Involved
#1
I work with a Class II device manufacturer, who is ISO 13485/MDSAP certified/FDA Registered and has Health Canada approval.
Due to product demand, we have leased another building for one of the product lines. We are NOT making any changes to the product spec, quality checks, or suppliers.

From what I can determine from this guidance document and our scenario (no changes to product spec, quality, suppliers):
The new facility will need to be covered by the manufacturer’s quality system certificate. The manufacturer is also required to submit a licence amendment which includes an attestation.
Guidance for the Interpretation of Significant Change of a Medical Device - Canada.ca

So does that I need to submit amendment to the MDEL or MDL? Anyone have any experience doing this?
 
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DannyK

Trusted Information Resource
#2
Are you adding any manufacturing facilities in the other building?
For the MDL:
It looks like you may need to contact your AUditing Organization to perform an extension to scope for the new address.
After you received the updated MDSAP certificated, you would send a fax back report to Health Canada notifying them of the change.
For the MDEL:
Provide an amended MDEL application to Health Canada.
 

gunnyshore

Starting to get Involved
#3
Hi Danny - yes, we are moving the entire product line to the other building. This will allow us to increase our output but not making any changes to the process, materials or suppliers. We will use the existing building to expand the other product lines.
Yes, we are already working with our Notified Body regarding the "significant change" and we expect they will conduct the audit after we are operational. Sounds like that will take care of the MDL.
For the MDEL, is this the right link for the form?
Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) - Canada.ca
 
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