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?
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?