CMO in Canada do they need MDSAP/13485 certification?

[jamiekniffen]

Hello,

I'm looking for help with the current situation. The legal manufacturer holds a MDSAP certificate. The company is looking at a CMO based in Canada to produce a Class II medical device only for export (there is no intention of registering and selling it in Canada).

Does the CMO of the finished product who would be a critical mfg of an aseptic filled product need to be 13485 or MDSAP certified? Looking at the establishment registration guidance for Health Canada I can't identify if the CMO needs to hold these designations.

Thank you!

Jamie

 

[DannyK]

Hi Jamie,

The CMO does not need to be MDSAP certified since they are not the legal manufacturer.
It would be beneficial for the CMO to have ISO 13485:2016 certification.

I hope this helps.

Danny