The target processing time for a Health Canada Class III medical device licence application is 75 days (15 screen days plus 60 review days) according to their guidance. Does anyone have practical experience about how long it will take to issue licence to you?


Thanks

Does anyone have experience with this they can share?

In our case the actual printed licence took 2 months after notification of the device licence, otherwise the timing was pretty much as you described.

Dear Le Chiffre,

"...2 months after notification of the device licence" means 2 months after your application submission? On the other hand, I noted that you said "the actual printed licence". My question is when and how Health Canada tell you that you are eligible to sell device? I guess if they will tell you the approved license number by email then you can sell prior to mailing the printed license.

Thanks

Leon

Sorry, I'll clarify.

From submitting the application, Health Canada took about a month to reply with a screening deficiency (some test reports were missing). 10 days later we submitted a complete set. Two months after that we received a request for further information (for some more design verification detail). A month after supplying the required information a fax was received indicating we'd been granted a licence (licence number included).

So with 2 interruptions the process took almost 5 months before we could sell product, notification came via fax.

The printed licence arrived in the mail almost 2 months later, but I don't think that's necessary to sell or import into Canada, it's just the number and confirmation from Health Canada.

Dear Le Chiffre,

This long application process really scared me a lot! I reviewed the Guidance named "Management of Applications for Medical Device Licences and Investigational Testing Authorizations", the "screening" is 15 days and "review" is 60 days on the last page. But as you mentioned, it took 1 month only for screening.

We provided the testing reports from third party testing lab and our own software validation report. From your experience, what else verification data we may miss?

Thanks

Dear Le Chiffre,

May I ask if your device has any mark, such as ETL, UL or CSA mark? I do not know if it is mandatory requirement or not.