MDLA - Extensions allowed for 60 day Request for Additional Information?

[GPjeri]

Got my initial review letter for a class III device that says the complete response must be sent in 60 days. Does anyone know if there's a way to file for an extension like you can with FDA?

Thanks in advance for you replies..

 

[Marc]

So that I can create a "Tag", and for those of us not in the field but follow along, MDLA = ?

 

[Stijloor]

So that I can create a "Tag", and for those of us not in the field but follow along, MDLA = ?

Medical Device Licence Application.

A Health Canada requirement.

Stijloor.

 

[Marc]

A quick "Bump". Can anyone help with this one? My Thanks in advance!

 

[RA Guy]

I don't have any experience with this specific letter.

I would call or e-mail the licencing office with your question. Health Canada representatives are generally responsive in my experience.