Canadian Medical Device License Fees

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Fees for the Examination of an Application for a Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-licence-application-review-funding-fees-drugs-health-products.html

Apr 1, 2022

Fees for Medical Devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html

Medical devices licence fees; Medical devices establishment licence fees; Fees for the right to sell medical devices; Fees for regulatory activities related to …

Guidance Document - Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html

Nov 18, 2013

Guidance Document: Medical Device Licence Renewal …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html

Fees for the Review of Medical Device Establishment …

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-medical-device-establishment-licence.html

The MDEL fee for new and annual licence review applications. The MDEL fee is a flat fee regardless of when in the fiscal year the application is received. The …

Frequently asked questions: Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html

If it is determined upon review that a device is not in fact a medical device, Health Canada will not refund the Medical Device Establishment Licence (MDEL) fee. Note: it is the applicant's …

Guidance Document - Fees for the Review of Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-fees-review-medical-device-licence-applications.html

Manufacturers submitting Class II, III and IV medical device licence applications and licence amendment applications will be charged a review fee. Fees are proportionate to …

Medical Devices Active Licence Listing (MDALL)

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html

The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

CANADA: new fees for Medical Devices from 1 April 2023

https://www.thema-med.com/en/2023/02/16/canada-new-fees-for-medical-devices-from-1-april-2023/

The fees for the fiscal year 2023-2024 are subject to a CPI of 6.8%, which has resulted in an increase in the fees for establishment and medical device licence …

Health Canada Increases Regulatory …

https://www.regdesk.co/health-canada-reg/

Medical Devices Establishment License – Application for new license and annual review of license $4590 (120 calendar days to issue decision) *Fees for the Right-To-Sell (RTS) licensed …

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