Health Canada Establishment License Guidance

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Guidance on Medical Device Establishment Licensing (GUI

(2 days ago) This guidance document covers licensing requirements for MDELs, including who requires an MDEL. It describes how to: 1. apply for an MDEL 2. submit an annual licence review before April 1 of each year 3. make change(s) to your existing licence (for example, an amendment or section 48 notification) 4. cancel … See more

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 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 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-0016

(8 days ago) WebThis guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device …

https://open.canada.ca/data/en/info/9618a1ad-72aa-470d-ab46-7d2ccfb57abc/resource/17d72a89-b589-4179-a08d-583b57da275d

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Guidance on Medical Device Establishment Licensing (GUI-0016)

(2 days ago) WebGuidance on Medical Device Establishment Licensing (GUI-0016) - Summary. This document provides guidance on regulatory requirements in relation to medical device …

https://open.canada.ca/data/dataset/b1e62e01-f0fb-478d-bc2e-fae3d640d416

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Drug establishment licences - Canada.ca

(8 days ago) WebAll Canadian drug establishments must have a drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug. This is required …

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

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DEL 175: Drug quality and shortage and discontinuation

(4 days ago) WebDrug Establishment Licensing Bulletin 175, April 29, 2024. Health Canada is closely monitoring impacts to shipping due to shipping disruptions through the Red Sea, …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/drug-quality-shortage-reporting-requirements-shipping-disruptions.html

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Guidance on Medical Device Establishment Licensing (GUI-0016)

(5 days ago) WebThis guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device …

https://open.canada.ca/data/en/dataset/9618a1ad-72aa-470d-ab46-7d2ccfb57abc

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Guidance on how to complete the application for a new …

(2 days ago) Web, a new device licence is a pre-market requirement for: any new device that was imported or sold in Canada after July 1, 1998 a licensed device whose licence type is being …

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

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Health Canada updates guidance on nitrosamine impurities in …

(4 days ago) WebDrug Establishment Licensing Bulletin 176, April 30, 2024. Health Canada has updated the Guidance on nitrosamine impurities in medications. Updates to general …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/health-canada-updates-guidance-nitrosamine-impurities-medications.html

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Guide To Health Canada's Medical Device Establishment Licence …

(1 days ago) WebTo ensure compliance with Health Canada’s regulations, holders of a Medical Device Establishment Licence (MDEL) must adhere to specific importation …

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 …

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

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Pharma in brief - Canada - Norton Rose Fulbright

(5 days ago) WebPharma in brief - Canada Health Canada releases draft guidance documents for consultation related to good manufacturing practices and drug establishment licensing …

https://www.nortonrosefulbright.com/-/media/files/nrf/nrfweb/imported/pharma-in-brief---health-canada-releases-draft-guidance-documents-for-consultation-related-to-good-manufacturing-practices-and-drug-establishment-licensing.pdf?revision=46978e50-02be-424d-ac6c-e44e05c8e0e8&revision=46978e50-02be-424d-ac6c-e44e05c8e0e8

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Health Canada on Medical Device Establishment Licensing

(7 days ago) WebAs mentioned, the present Health Canada guidance provides additional clarifications regarding the regulatory requirements related to medical device …

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

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Guidance on Drug Establishment Licences and Associated Fees

(1 days ago) WebHealth Canada endeavours to provide timely guidance. These guidelines are not the only way establishment licensing regulations can be interpreted, and are not intended to …

https://publications.gc.ca/collections/collection_2019/sc-hc/H14-311-2019-eng.pdf

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Drug Establishment Licensing: An Industry Perspective - CAPRA

(3 days ago) WebDrug Establishment Licence 02 Brief discussion on Health Canada A Drug Establishment Licence (DEL) is a document issued by Health Canada to an …

https://capra.ca/_uploads/61a5010f32874.pdf

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