MDL Medical Device License
Medical Device Licence
Canadian Certification
The Medical Device Licence (MDL) authorizes the sale of our devices in Canada, confirming they meet Health Canada's safety, effectiveness, and quality requirements.
Authorized for sale in Canadian market
Compliance with Canadian Medical Device Regulations
Medical Device Licence
Click to view full certificate
What Is a Health Canada Medical Device Licence (MDL)?
A Medical Device Licence (MDL) is Health Canada's product-level authorization required to legally sell or import medical devices in Canada. Issued under the Canadian Medical Devices Regulations (CMDR), it confirms a device meets national standards for safety, efficacy, and quality.
Who needs it: Manufacturers of Health Canada Class II, III, and IV medical devices.
Prerequisite: A valid ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP), with Canada included in scope.
Verification: Active licences are recorded in Health Canada's Medical Devices Active Licence Listing (MDALL) database.
Erythros' multi-wavelength laser facial device is licensed for sale in Canada under this Health Canada MDL — view the certificate above for full licence details.
North American Market
Our Medical Device Licence demonstrates our devices' compliance with Canada's rigorous healthcare standards. By meeting these requirements, we ensure our Canadian customers receive safe, effective, and reliable products that meet their health needs.