Health Canada Medical Device Establishment License 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: Guidance Document: Fees for the …

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

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

Note that there is no fee to amend a medical device establishment licence. Return to footnote 2 referrer. 3. Treasury Board of Canada Secretariat, 2016. Return to …

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

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 …

Establishment Licences - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html

How to Pay Your Establishment Licence Fees [2018-09-07] Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097) Guidance on …

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 on Medical Device Establishment Licensing (GUI-0016) - Summary. From Health Canada’s Regulatory Operations and Enforcement Branch. In light of COVID-19, …

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 …

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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