A medical device establishement license (MDEL) is required for manufacturing, importing or distributing medical devices in Canada. The evidence for a MDEL, particularly for manufacturing typically requires ISO 13485 or 13488 standards to be met.
The performance target for the review of a MDEL is 120 days. Keep in mind licensing may happen sooner than this target timeline. Quality Smart Solutions has submitted MDELs and have had them reviewed and licensed within one week.
Depending on the activity of the MDEL a fee may be due either at time of submission of application or after one year when renewal of the application is due. Fees are based on either a base structure prescribed by Health Canada or based on revenue.