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.