Contact Device Licensing Health Canada

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Medical device licensing - Canada.ca

(8 days ago) Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database. See more

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

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Medical Devices Active Licence Listing (MDALL) - Your …

(8 days ago) WEBSelecting the Active Licence Search link takes you to the Medical Devices Active Licence Search window. This window is identical to the original MDALL search and displays the …

https://health-products.canada.ca/mdall-limh/index-eng.jsp

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Medical Devices Directorate – Health Canada - Canada.ca

(7 days ago) WEBThe Medical Devices Directorate (MDD) is Canada's regulator of medical devices for human use. Before authorizing the sale of a medical device in Canada, we verify that …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

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Guidance on how to complete the application for a new …

(4 days ago) WEBUnder the Medical Devices Regulations, a new device licence is a pre-market requirement for: any new device that was imported or sold in Canada after July 1, 1998; …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence/implementation.html

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Guidance on Medical Device Establishment Licensing (GUI …

(2 days ago) WEBIt provides guidance on the regulatory requirements for medical device establishment licences (MDELs), including: when and how to apply for an MDEL and. …

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

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Guidance documents – Medical devices - Canada.ca

(3 days ago) WEBMedical Devices Guidance Documents. Guidance on Medical devices for an urgent public health need [2024-01-03] Implementing the regulatory enrolment …

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

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Medical Devices Establishment Licence (MDEL)Listing

(7 days ago) WEBThe MDEL listing contains information about the licensed establishment, such as their company ID, licence number, company name, address, authorized activities and …

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

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Guidance on Medical Device Establishment Licensing (GUI …

(1 days ago) WEBThis guidance document explains: Medical devices establishment licensing regime under sections 44 to 51.1 of the Medical Devices Regulations to the Food and Drugs Act. Responsibilities of any …

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/document.html

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Medical devices active licences search - health …

(Just Now) WEBMedical devices active licences search. From Health Canada. Archived Licence Search. You may search by one of the following search options only: company name or …

https://health-products.canada.ca/mdall-limh/prepareSearch?type=active

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Guidance on medical device establishment licensing (MDEL).

(1 days ago) WEBCanada. Health Canada, issuing body. Title : Guidance on medical device establishment licensing (MDEL). Variant title : Guidance on medical device establishment licensing …

https://publications.gc.ca/site/eng/9.878679/publication.html

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Medical Devices Drug and Health Products Portal

(2 days ago) WEBThe incidents in this database represent the perspective of those who send Health Canada the reports. Report a medical Device Problem (For Health Care Professionals) The …

https://dhpp.hpfb-dgpsa.ca/medical-devices

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Licences - Canada.ca

(9 days ago) WEBMedical Devices Licence Listings. Medical Devices Active Licence Listing (MDALL) Purchase of Licensed Medical Devices for Use in Health Care. Date: 2001-01 …

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

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Guidance Document

(2 days ago) WEBTo obtain additional information, please contact: Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-268-2019-eng.pdf

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Health Canada Medical Device License (MDL) and MDEL Registration

(8 days ago) WEBA Canadian Medical Device License (MDL) is required for companies selling Class II - IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit …

https://www.emergobyul.com/services/health-canada-medical-device-license-mdl-and-mdel-registration

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Health Canada's MDALL Registration: Everything you should know

(4 days ago) WEBThe MDALL registration process consists of several steps that manufacturers must follow to obtain a medical device license. Here’s a step-by-step breakdown of the …

https://qualitysmartsolutions.com/blog/demystifying-health-canadas-mdall-everything-you-should-know-about-registering-medical-devices/

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Guidance on how to complete the application for a new …

(2 days ago) WEBFor a single device: Enter the name of the device in the first column. Enter the identifier for the device (bar code, catalogue, model or part number) in the second column. Check …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-315-2021-eng.pdf

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Obtaining a Health Canada Medical Device License (Case Study)

(Just Now) WEBThis article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device …

https://medicaldeviceacademy.com/health-canada-medical-device-license/

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Health Canada on Medical Device Establishment Licensing

(7 days ago) WEBMay 17, 2021. Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance …

https://www.regdesk.co/health-canada-guidance-on-mdel-applications/

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Canada's Health Canada - Global Regulatory Partners, Inc.

(2 days ago) WEBHealth Canada Medical Device License (MDL) The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. …

https://globalregulatorypartners.com/countries/north-america/canada-health-canada/

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Health Canada Guidance on Applying for an MDEL RegDesk

(Just Now) WEBJun 1, 2021. Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects …

https://www.regdesk.co/health-canada-guidance-on-applying-for-an-mdel/

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WEBFor more information, please contact: Health Canada Address Locator 0900C2, Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1 …

https://publications.gc.ca/collections/collection_2020/sc-hc/H14-334-2019-eng.pdf

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How to ensure Health Canada compliance for Medical Devices?

(4 days ago) WEBObtain Appropriate Regulatory Approvals for Your Device: One important step to ensure that your device is compliant with Health Canada’s regulations is to …

https://qualitysmartsolutions.com/blog/how-to-comply-with-health-canada-regulations-for-medical-devices/

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