Health Canada Medical Device Registration Fees

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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. custom …

Fees for Health Canada - Canada.ca

https://www.canada.ca/en/health-canada/services/funding/fees-health-canada.html

Fees for the Examination of an Application for a Medical Device Licence Fee Fee Amount in ...

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

In accordance with subsection 48 (1) of the Fees in Respect of Drugs and Medical Devices Regulations, a manufacturer is eligible for a reduced fee for the right to …

Medical devices - Canada.ca

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

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, …

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/fees-review-medical-device-licence-applications-2019/document.html

If the application for remission is accepted by Health Canada, the fee for the review of a medical device application will be an amount equal to 10% of the …

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 …

Health Canada and FDA eSTAR Pilot | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/health-canada-and-fda-estar-pilot

FDA user fees: MDUFA user fees Health Canada user fees: Fees for the examination of an application for a medical device license Review timeline for eSTAR …

Health Canada Increases Regulatory Prices of Medical …

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 class II, III, or IV …

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