How to apply Device Licence of Canada?

[Roland chung]

Hello all,

I am new for the Canadian medical device approval. I would appreciate it if one can provide a flowchart of approval.

Thanks and regards,
Roland

 

[DannyK]

1st step- Determine the classification of yoour medical devices. If the device is class III or IV, you need to include design controls.

2nd step-Get ISO 13485:2003 certification with an approved CMDCAS registrar

3rd step- make sure that the scope of the certificate covers the medical devices that you want to license.

4th step- Once you receive your certificate, send an application form ( available on the Health Canada website) to Health Canada along with your ISO 13485 certificate.

 

[Roland chung]

DannyK, my many thanks to you.

It seems the info you mentioned mainly relate to quality system. How about testing of equipment? And what documents should be submitted to Health Canada in order to get the license? Is there a guideline?

 

[somashekar]

How about testing of equipment?

If you have identified that Canada market is also your consideration at the design input stage, all the necessary testing and limits as applicable to Canadian standards must have been considered. The application forms in the Health Canada site contains all these requirements.
I am surprised if you (or your regulatory guys for design input) have not explored the Health Canada site.

 

[Roland chung]

Somashekar, thank you for your input.

I am engineer and I indeed have not explored the Health Canada Website yet, because there are a bit much info in the website and I want to get some helpful opinions firstly in here.