Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)

L

Leandro

Hi!

We're a company about to bring operations to Canada and we're in need to register our products - Class III prosthesis (in titanium).
Also, there's the need to find a Contract Manufacturer to produce for us locally.

Looking forward to hearing from you.
 

Armen

Registered
Hello,
I used to work at a company and needed a Registrar for Canadian market and I contacted Accademia Qualitas.
 

Watchcat

Trusted Information Resource
If you need to register the device in Canada, why the reference to FDA in your subject line?

What exactly do you want?
- Someone to prepare the Medical Device License application for you?
- Someone to recommend an appropriate Canadian contract manufacturer?
- Someone to assist you in obtaining a MDSAP certificate?
- All of the above?
 
Last edited:

Mikilk

Involved In Discussions
In order to register your devices in Health Canada, you will need to have AMS approved under MDSAP program by a recognized Notified Body the registration process for class III required a very well written application file and the authority review time for Class III is approx 60 days.
will be happy to provide additional information
Good luck
 
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