Canada Medical Device - Licencing Process of a CE Marked Device

[dionysisf]

Hello,

We are a European Medical Device Manufacturer. We have CE marked devices Class IIb and we are certified according ISO 13485 under CMDCAS (SGS UK).

We are planning to sell in Canada, and we are wondering how difficult it is.
After reading elsmar, we understood that a "Medical Device Licence Application" shall be sent to Health Canada.

And how long it will take to be completed?

Thank in advance

 

[DannyK]

You are right a medical device license application must be completed. If it is for a class II medical device it should not take long. I submit on behalf of my clients and it usually takes about 3-4 weeks to get the license.

For a class III & IV, the review times are longer and there are more submission requirements.

Please do not hesitate to PM me for additional questions.

 

[CBAL08]

Go to Health Canada's website and look for Medical Device License.

It is a very straight forward process as long as you have all the requirements fulfilled.

Fill the form up and send it....With required documents.....

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/licapp_demhom_cla2-eng.pdf