Health Canada License Amendment

Listing Websites about Health Canada License Amendment

Medical Devices Licence Amendment Minor Change Form

(6 days ago) WebMedical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences and/or COVID-19 medical device authorizations Manufacturers of an existing medical device licence …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-back-form-guidance-manufacturer.html

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Guidance on how to complete the application for a new …

(2 days ago) WebLicence application type: The application may be submitted as a single device, system, test kit, device group, device family or device group family. The term “test kit” applies only to …

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

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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 …

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

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Guidance on clinical evidence requirements for medical devices

(4 days ago) WebA comparator device should be licensed in Canada. If not, please provide objective evidence of safety and effectiveness to Health Canada, along with a side-by-side …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-347-1-2023-eng.pdf

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Guidance Document

(2 days ago) WebThis document outlines the way in which Health Canada manages applications for medical device licences. 1.2 Scope and Application This guidance document applies to the …

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

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Natural Health Product Licence Amendment and Notification Form …

(1 days ago) WebThe Amendment and Notification Form (ANF) is the exclusive form to be used for submitting post licensing changes for a licensed natural health product (NHP) to the …

https://open.canada.ca/data/en/dataset/f28a5ec1-271b-4b20-af39-cf75881f044c/resource/22f874ec-8b02-4698-9d7e-14b99b4bc82a

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Guidance Document - Medtech Insight

(9 days ago) WebLicence Amendment Minor Changes2 (Faxbacks) for Class II, III and IV medical devices New and Amendment Medical Device Licence Applications for Private Labels Health …

https://medtech.pharmaintelligence.informa.com/-/media/supporting-documents/medtech-insight/2019/06/can_1.pdf

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Canada Gazette, Part 1, Volume 156, Number 51:

(1 days ago) WebThe amendments would enhance Health Canada’s capacity for continued oversight, assessment, and communication at both the licensing stage and once …

https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(9 days ago) Web43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

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Medical Devices Regulations ( SOR /98-282) - Site Web de la

(Just Now) WebFederal laws of Canada. 32.5 (1) Subject to subsection (2), the Minister may cease to recognize a person as a registrar if the Minister has reasonable grounds to believe that …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-3.html

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Health Canada - Medical Device (Amendment?) License? - RAPS

(2 days ago) WebPosted 09-Mar-2023 18:22. Knowing whether an existing Canadian Medical Device Licence can be amended or an entirely new Medical Device Licence is required depends on a …

https://connect.raps.org/discussion/health-canada-medical-device-amendment-license

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Health Canada Notice on Interpretation of Significant Changes

(5 days ago) WebAt the same time, the requirement related to applying for an amendment medical device license applies only for Class III and IV medical devices. As stated by …

https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/

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Canada Gazette, Part 2, Volume 157, Number 4: Order Amending …

(7 days ago) WebIn general, Health Canada charges fees for regulatory activities related to medical devices (e.g., the examination of licence submissions, amendment …

https://canadagazette.gc.ca/rp-pr/p2/2023/2023-02-15/html/sor-dors21-eng.html

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HEALTH CANADA: updates fees Medical Devices from 1st April …

(1 days ago) WebApplications for Class II, III or Class IV licence or licence amendment – private label medical device. $ 147. $ 152. Compared to 2021, there has also been an …

https://www.thema-med.com/en/2022/03/28/health-canada-updates-fees-medical-devices-from-1-april-2022/

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Health Canada is proposing amendments to regulations on …

(3 days ago) WebJanuary 19, 2023. Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees …

https://www.emergobyul.com/news/canada-update-proposed-amendments-regulations-licensing-drugs-and-medical-devices

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