MEDICAL DEVICE LICENCE (MDL)
All risk II, III, and IV medical devices must be registered with Health Canada prior to their sale in Canada. MEDERA will handle all aspects of medical device submission preparation and on-going contact with the Medical Devices Bureau to follow through on product approvals. We can spearhead the entire registration project or just handle specific components of the submission process for you, such as a Quality Control Review of submissions prepared by your own staff.
MEDERA can handle the following types of regulatory submissions to Health Canada's Medical Devices Bureau:
- Risk Class II
- License Amendments
- Private Label Medical Devices
- Private Label Medical Device License Amendments
- Changes to the Name of Licensed Devices
- Changes to Manufacturer Name/Address
- Non-Significant additions or deletions
Contact us to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a healthcare product in Canada, click here.