Medical Device Establishment Licensing (MDEL) Post Market Cost Recovery

By: Teri Dickinson, Regulatory Affairs Group Manager, email

Starting April 1, 2020, new medical device Establishment Licensing (MDEL) fees will come into effect.

What can you expect to pay?

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

There will be some changes to Medical Device establishment licensing policies, including:

• Updated MDEL Application Form (FRM-0292)
• The pause-the-clock policy will be implemented (GUI-0016) – this provides 30 business days to respond to deficiency notice and two opportunities to address any given deficiency

What is staying the same?

• The performance standard for processing each MDEL application remains at 120 calendar days.
• The Annual Licence Review (ALR) Package will continue to be sent in late December/early January and returned to Health Canada before April 1st.
• The 2020 ALR process will not be affected by these cost recovery changes.

Need help sorting through the new policies?

Contact:
Dell Tech Laboratories
info@delltech.com
519-858-5021

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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