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Medical Devices Establishment Licence (MDEL)Listing

(7 days ago) WebHealth Canada has suspended or cancelled the MDEL for failure to comply with regulatory requirements ; the company requested that the MDEL be cancelled as they have ceased …

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

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Guidance on Medical Device Establishment Licensing (GUI

(2 days ago) WebMDEL. Distributing. I am in Canada. I buy medical devices from a manufacturer and/or supplier (importer or distributor) in Canada and sell them in Canada …

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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Medical device licensing - Canada.ca

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

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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Establishment Licences - Canada.ca

(Just Now) WebAll Canadian drug establishments must hold, since January 1, 1998 an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a …

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

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Guidance on medical device establishment licensing (GUI

(7 days ago) WebManufacturers of the medical devices that you import or distribute will not be accepted as a site. A site must be in the same country as the establishment. A post …

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/how-apply-mdel.html

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Updates to the medical device establishment licence - canada.ca

(5 days ago) WebOn December 4, 2023, Health Canada’s Regulatory Operations and Enforcement Branch revised the medical device establishment licence (MDEL) application form. The form is …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/updates-frm0292-instructions.html

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Updates to the guidance on medical device establishment

(1 days ago) WebOn September 6, 2023, Health Canada's Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device …

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

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Medical Devices Establishment Licence Listing - health …

(3 days ago) WebHealth Canada has suspended or cancelled the MDEL for failure to comply with regulatory requirements ; the company requested that the MDEL be cancelled as they have ceased …

https://health-products.canada.ca/mdel-leim/index-eng.jsp?wbdisable=false

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About medical devices - Canada.ca

(2 days ago) WebManufacturers and importers must have procedures in place for reporting recalls and serious medical device problems to Health Canada. (Note: importers and distributors must have …

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

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Medical Devices Compliance Program Bulletin - Canada.ca

(6 days ago) WebSearch Canada.ca. Search. Menu Main Menu . Jobs and the workplace; Immigration and citizenship; What MDEL holders need to know about the annual …

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

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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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How Health Canada inspects medical device establishments: …

(4 days ago) WebThese guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html

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How Health Canada inspects medical device establishments: About

(2 days ago) WebHealth Canada may inspect anyone who has a medical device establishment licence (MDEL) to ensure they comply with the Act and the Regulations. Those …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064/about-inspections.html

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Medical device inspections - drug-inspections.canada.ca

(5 days ago) WebMedical device inspections. Medical devices made in Canada or abroad must meet high safety and quality standards before being sold to Canadians. Canada licenses and …

https://www.drug-inspections.canada.ca/md/index-en.html

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Guide To Health Canada's Medical Device Establishment Licence …

(1 days ago) WebIn Canada, the sale and distribution of Class II, III, and IV medical devices are strictly regulated to ensure safety and effectiveness. Manufacturers and distributors …

https://substancelaw.com/guide-to-health-canadas-medical-device-establishment-licence-mdel-in-canada/

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Guidance on Medical Device Establishment Licensing (MDEL)

(1 days ago) WebHealth Canada April 1, 2020 April 1, 2020 Guidance on Medical Device Establishment Licensing and Medical Device Establishment Licence Fees (GUI-0016) version 7 (April 1, …

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

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