Medical Device License Renewal (MDL) Period - Health Canada

[snoopy2017]

Hi everyone,

We have a device that was approved by Health Canada in spring 2017. Because there is an annual renewal due on November 1, my question is whether we are supposed to receive a renewal package even though our licence was issued in the spring? I understand the renewal requirements but since I am not aware of any renewal package for this licence, I wonder if I should contact Health Canada about this.

Thank you.

 

[shimonv]

Hi Snoopy2017,
Please refer HC guidance document on Medical Device Establishment Licencing - https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/licences/directives/gui-0016-eng.pdf

Section 4.2 says the following:
"4.2 Annual Review Applications
Effective April 1, 2011, an establishment licence will no longer expire on December 31 of each year, and there will be no expiry date indicated on establishment licences. As indicated in the revised Medical Devices Regulations, all MDEL holders must submit a request for an annual review, before April 1 of each year to continue to hold a valid licence. The applicable fees are due with the application.
As a courtesy, Health Canada will continue to send a reminder to licence holders and provide an annual review package to each MDEL holder. However, it continues to be the applicant’s responsibility to ensure that an annual review application is submitted to arrive at Health Canada before April 1 of each year. "

Section 5.1.2 says:
"5.1.2 First Year of Activities
For applicants who have not completed their first full calendar year of conducting activities under any MDEL, the payment of the applicable MDEL fee is deferred until the end of the first full calendar year."

Good luck,
Shimon

 

[snoopy2017]

Hi,

Thanks for your response. I am asking specifically about Medical Device Licence Renewal, not the Establishment License Renewal. The regulations do not say anything about a licence that was just obtained a few months before the renewal date.

Thanks so much again.

 

[shimonv]

I see. From past experience they will not charge you for the first year from the time you received the license (similar concept to establishment license renewal).

Shimon

 

[snoopy2017]

Thanks. Should we receive at least a renewal package?

 

[snoopy2017]

what I mean is should we receive at least a regulatory renewal package to document even if the invoice is deferred until 2019? Thanks.

 

[shimonv]

That has been my experience with Health Canada.
You can also contact them by email if in doubt; they are reaponaive and kind.