Health Canada Medical Device Establishment Licence Fee

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Fees for Medical Devices - Canada.ca

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

The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt from medical device licensing and therefore no fees apply: Class I medical devices. …

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

Frequently asked questions: Medical device …

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

What is a medical device? The term 'medical device' covers a wide-range of …

Medical Device Establishment Licence (MDEL) …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) In light of COVID-19, please only email any completed MDEL application forms, …

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html

Guidance has been updated to incorporate the applicable sections of the amended Medical Device Regulations, subsection 44 (3) and (4) and paragraph 45 (j). Guidance has been …

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 …

Drug establishment licence (for human use) and …

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

The updated fee amounts shown below reflect the annual fee adjustment required by the fee-setting authority governing each fee line. For more information and on …

Medical Devices Establishment Licence Listing - health …

https://health-products.canada.ca/mdel-leim/index-eng.jsp

The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and …

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