Health Canada Medical Device License Review Time

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What MDEL holders need to know about annual licence …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2022.html

We process ALR applications in the order we receive them. Our service standard is 120 calendar days to review and process a complete and paid application. For more information on the completeness of an application, please refer to the MDEL application instructions. As a courtesy, we send out an ALR … See more

Management of Applications for Medical Device Licences

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations.html

Medical Device Directorate, Device Licensing Services Division Health Canada 11 Holland Avenue Address Locator 3002A Ottawa, Ontario K1A 0K9 By email: meddevices …

Guidance Document: Management of Applications for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html

For linked medical device applications where different timelines apply (e.g. a Class III implantable device and its associated Class II delivery system, where a system …

Service Standards for Medical Device Submission …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/service-standards-high-volume-regulatory-authorizations/service-standards-medical-device-submission-evaluations-under-medical-device-regulations.html

The guideline Management of Applications for Medical Device Licences and Investigational Testing Authorizations outlines the way Health Canada manages …

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 …

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

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

Manufacturers of medical devices that are licensed for sale, in Canada, are required to inform Health Canada each year before November 1 that the information …

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 licence and …

Processing Time for a Health Canada Class III Medical Device …

https://elsmar.com/elsmarqualityforum/threads/processing-time-for-a-health-canada-class-iii-medical-device-licence-application.33489/

1 2 Next L luloo117117 Apr 9, 2009 #1 The target processing time for a Health Canada Class III medical device licence application is 75 days (15 screen days …

Health Canada Guidance on MDEL: Annual …

https://www.regdesk.co/health-canada-guidance-on-mdel-annual-review-updating-cancellation-and-suspension/

The regulating authority will review the application within 120 calendar days from the date it was received. The license holder will receive two confirmation …

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