Regulatory Open Forum

Hi Linda,

You are correct that the requirements for what is submitted to Health Canada for a Risk Class II medical device is very basic.  This is based on the fact that a risk Class II device is considered a low risk device and that Health Canada accepts the manufacturer's attestation in the application form that they have all the supporting safety and effectiveness data on file to meet the requirements of Sections 10-20 of the Canadian Medical Devices Regulations.  Health Canada always reserves the right to request to see this data on file, but from my experience of submitting licence applications to HC for over 16 years, they have never actually asked for this for a Class II device (other than for high level disinfectants, which is a different story ��).

The Risk Classification of devices in Canada doesn't always line up with how the FDA classifies them, so there are some instances that a device in Canada is considered a Risk Class II, but in the US, it could be a 510(k) or even a PMA if there is no predicate.  There are instances where I have seen the opposite as well of course.

If your IFU/User Manual includes a good description of the device, there is also no need to include the device description in Section 2.  I do typically include a cover letter (though it is not mandatory) to explain any nuances that may cause confusion to the person processing the licence application.

I hope this helps,

Shirley  

Shirley Furesz, Ph.D., RAC

Amerisource Bergen

TPIreg, Innomar Strategies

Director Regulatory Affairs, Medical Devices

Cell phone: 519-242-6476

Fax: 888-887-8686

3470 Superior Court

Oakville ON L6L0C4

Canada

Regulatory Services | Innomar Strategies (innomar-strategies.com)

United in our responsibility

to create healthier futures

Hi Linda,

You are correct that the requirements for what is submitted to Health Canada for a Risk Class II medical device is very basic.  This is based on the fact that a risk Class II device is considered a low risk device and that Health Canada accepts the manufacturer's attestation in the application form that they have all the supporting safety and effectiveness data on file to meet the requirements of Sections 10-20 of the Canadian Medical Devices Regulations.  Health Canada always reserves the right to request to see this data on file, but from my experience of submitting licence applications to HC for over 16 years, they have never actually asked for this for a Class II device (other than for high level disinfectants, which is a different story ��).

The Risk Classification of devices in Canada doesn't always line up with how the FDA classifies them, so there are some instances that a device in Canada is considered a Risk Class II, but in the US, it could be a 510(k) or even a PMA if there is no predicate.  There are instances where I have seen the opposite as well of course.

If your IFU/User Manual includes a good description of the device, there is also no need to include the device description in Section 2.  I do typically include a cover letter (though it is not mandatory) to explain any nuances that may cause confusion to the person processing the licence application.

I hope this helps,

Shirley  

Shirley Furesz, Ph.D., RAC

Amerisource Bergen

TPIreg, Innomar Strategies

Director Regulatory Affairs, Medical Devices

Cell phone: 519-242-6476

Fax: 888-887-8686

3470 Superior Court

Oakville ON L6L0C4

Canada

Regulatory Services | Innomar Strategies (innomar-strategies.com)

United in our responsibility

to create healthier futures