Medical Devices
Pharmaffair offers manufacturers, distributors, and importers complete regulatory services from early concept to regulatory approvals.
We can assist your company with:
• Medical Device Establishment Licence (MDEL) (required by Health Canada for Class I Medical Devices)
• Investigational Testing Authorization (ITA) Applications
• Licence Applications for Class II, III, and IV Medical Devices
• Licence Amendments for Class II, III or IV (significant changes)
• Licence Amendment Fax-back applications (minor changes)
• Regulatory Submissions
• Post-NOC changes
Health Canada's Medical Device Licence Application Review fees as of April 1, 2018 can be found here.