Canadian Market Approval
Health Canada's Medical Device Licence (MDL) is required for the sale of Class II, III, and IV medical devices in Canada. The RX1 holds a valid MDL confirming it meets Canadian Medical Devices Regulations under the Food and Drugs Act.
- Health Canada Medical Device Licence on file
- Compliant with Canadian Medical Devices Regulations
- Manufacturer holds MDSAP recognition required for MDL
Full documentation available on request. Contact support@revogenlab.com.