Canadian Medical Device and IVD (In Vitro Diagnostic) Requirements

[lennon121]

All,

My company are looking at selling medical and IVD into Canada and I wondered if someone could lead me in the right direction of the requirements to do this, do they have Quality standards? or regulatory requirements??

Many Thanks

L

 

[tamale]

You will find everything you need on the following web site.

I was involved with them 2 years ago and found them very helpfull.

http://www.hc-sc.gc.ca/index-eng.php

Tamale

 

[DannyK]

IVD's are regulated as medical devices in Canada. To get a license, you need to get ISO 13485:2003 along with Canadian Medical Device Regulations. The register has to be approved by SCC.

If you need any more information, please do not hesitate to send me a private message.

 

[yana prus]

I would suggest to start with the classification of IVDD according to Canadian requirements - you can use the "Guidance For The Risk Based Classification System of In Vitro Diagnostic Devices"
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/ivd-rsk_idiv-rsq-eng.pdf

"Guidance for the Labelling of In Vitro Diagnostic Devices" is very helpful too.
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/md-im/labl_etiq_ivd_div-eng.pdf