We have 510k medical device that we would like to export to Canada. I found two (2) different applications on the Health Canada website

1. New Class II Medical Device Licence Application Form
2. Medical Devices Establishment Licence application

I am not sure which application to use. Can anyone advise?

Thanks, Ted

We have 510k medical device that we would like to export to Canada. I found two (2) different applications on the Health Canada website

1. New Class II Medical Device Licence Application Form
2. Medical Devices Establishment Licence application

I am not sure which application to use. Can anyone advise?

Thanks, TedI believe you need both.

I believe you need both.
.....as well as the CMDCAS ISO 13485 Certificate from a valid registrar.....

You are required to have a registered quality system (CAN/CSA ISO 13485:2003).

You are required to have a device licence

You are not required to have an establishment licence (unless other conditions apply).

See page 5 of attached.