Information on Medical Devices

Medical Devices Licences:
please call the Medical Devices Bureau at 613-957-1909.

Medical Devices Premarket review:
please call the Device Evaluation Division of the Medical Devices Bureau, at 613-954-0297.

Medical Devices Standards:
please call the Device Surveillance Division of the Medical Devices Bureau, at 613-954-0288.

Information regarding device recalls:
please contact the Health Products and Food Branch Inspectorate at 1-800-267-9675.

Special Access Program for medical devices:
please call the Device Evaluation Division of the Medical Devices Bureau at 613-946-8711.
E-mail: sap_devices_mdb@hc-sc.gc.ca
Facsimile: 613-957-1596

ISO 13485 Quality System requirements :
please call the Quality Systems Section of the Medical
Devices Bureau at 613-952-8250
E-mail : ISO13485_CMDCAS_SCECIM@hc-sc.gc.ca