Canadian Certification Required for a USA-Based Class I Medical Device?

[LGDeneault]

Greetings E-Covers!

My USA-Based company is interested in marketing and selling its Class I medical devices in Canada. What all has to be done to make this happen?

Thanks, in advance and as always, for your time and consideration!

Best Regards,

LEE

 

[Al Rosen]

Greetings E-Covers!

My USA-Based company is interested in marketing and selling its Class I medical devices in Canada. What all has to be done to make this happen?

Thanks, in advance and as always, for your time and consideration!

Best Regards,

LEE

I think your question can best be answered at the (broken link removed)

 

[gdwaikle]

Greetings E-Covers!

My USA-Based company is interested in marketing and selling its Class I medical devices in Canada. What all has to be done to make this happen?

Thanks, in advance and as always, for your time and consideration!

Best Regards,

LEE

Health Canada does not allow Notified Body's to Certify companies that only manufacture Class 1 Medical Deivices. If you also mfg. Class 2 they can come in and certify you to ISO 13485: 2003. The time frame to do that is April 2006 for Canada vs July 2006 for the EU.

Some Notified Body's were in fact Certifying companies that only manufactured Class 1 Medial Devices and this last year Health Canada sent out a warning to all of them that they can not do that any more and in fact the ones that had been Certified all had to be noitified.

As Al Rosen suggested go to the Health Canada Web link to find out more, but essentially you should be able to ship any class 1 device into Canada without being Certified.