Medical Devices: Evaluation and Right to Sell Fees

 In Regulatory Affairs, Uncategorized

By: Teri Dickinson, Regulatory Affairs Group Manager, email

Are you ready for Cost Recovery implementation coming into force on April 1, 2020?

Starting April 1, 2020, new medical device submission and right to sell fees will be phased in over the next 4 years.

What fees can I expect to pay?

Class II LicenceRight to Sell Annual Fees (Class II, III, or IV)

Not only are the fees changing but the time at which you pay is also changing.  Once your submission has been accepted into the first review, an invoice will be generated and payment is required within 30 days.

New fee forms will be available in March 2020 with some notable changes.

New fee lines:

  • Class II Amend
  • Class II, III, IV Private Label, New and Amend

Fee lines that no longer exist:

  • Class III Near Patient in vitro diagnostic devices (Merged with Class III New)
  • Class IV Near Patient in vitro diagnostic devices (Merged with Class IV New)
  • Class IV devices that contain human or animal tissue (Merged with Class IV New)

Need help with estimating your costs?

Dell Tech Laboratories

Dell Tech has provided professional, confidential consulting services to the chemical specialty

industry in Canada, the USA, Europe, and Asia for the last 40 years.

Contact us today for more information.


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