Health Canada Change Guidance

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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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Health Canada Implementation of ICH Q12: CMC Changes

(Just Now) WEB• Sponsors are to notify Health Canada of the change within 15 days of the date when the manufactured product is first released to the Canadian • Concept of …

https://www.casss.org/docs/default-source/cmc-strategy-forum-north-america/2021-cmc-na-speaker-presentations/hamel-hugo-health-canada-2021.pdf?sfvrsn=9db6e87d_8

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Health Canada Draft Revised Guidance Documents on Post-NOC …

(7 days ago) WEBAs with the current version of the guidance, Health Canada also provides recommendations for documentation to support the change. Currently, the Post-NOC …

https://capra.ca/en/blog/health-canada-draft-revised-guidance-documents-on-post-noc-changes-quality-for-consultation-2021-09-30

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Health Canada Draft Guidance on Significant Changes: Overview

(4 days ago) WEBHealth Canada, the country’s regulatory agency in healthcare products, has published a draft guidance document dedicated to interpreting “significant change ” of a …

https://www.regdesk.co/health-canada-draft-guidance-on-significant-changes-overview/

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Guidance Document

(2 days ago) WEBChanges: Safety and Efficacy Document. Date Adopted: 2009/09/02 Revised Date: 2019/08/12. Effective Date: 2019/08/12. Health Canada is responsible for helping …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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Health Canada Draft Guidance on Significant Changes: Procedures

(6 days ago) WEBHealth Canada, the country’s regulatory agency in healthcare products, has published a draft guidance document dedicated to interpreting “significant change” of a …

https://www.regdesk.co/health-canada-draft-guidance-on-significant-changes-procedures-explained/

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Health Canada on Significant Changes: Guidance for Implementation

(8 days ago) WEBAug 4, 2021. Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to …

https://www.regdesk.co/health-canada-on-significant-changes-guidance-for-implementation/

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Guidance Document

(6 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance …

https://www.publications.gc.ca/collections/collection_2021/sc-hc/H164-277-2021-eng.pdf

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Health Canada Draft Guidance on Significant Changes: Types of …

(2 days ago) WEBHealth Canada, the country’s regulatory agency in healthcare products, has published a draft guidance document dedicated to interpreting the “significant change” …

https://www.regdesk.co/health-canada-draft-guidance-on-significant-changes-types-of-changes/

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Health Canada: Draft guidance on how to interpret ‘significant …

(Just Now) WEBThis will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to …

https://bivdanewsletter.com/regulatory-affairs-newsletter/other-updates-regulatory-affairs-newsletter/health-canada-draft-guidance-on-how-to-interpret-significant-change-of-a-medical-device/

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Guidance Document

(2 days ago) WEBover the past several years such as: the Notice on how Health Canada initiated safety changes for human drugs under the Protecting Canadians from Unsafe Drugs Act …

https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf

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Guidance on the use of COVID-19 vaccines during the fall of 2024

(5 days ago) WEBIt should be noted that there is no change to the recommendations published in October 2023 for unvaccinated individuals 6 months to under 5 years of age who are …

https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-covid-19-vaccines-fall-2024.html

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Guidance Document

(2 days ago) WEBHealth Canada email address. Additional amendments were made to correct or complete information 2019/05/15 Updated in accordance with the new Health Products and Food …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-eng.pdf

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Post-NOC Changes – Quality Guidance Overview and Update

(3 days ago) WEBPost-NOC Changes – Quality Guidance Overview and Update. Krishnan R. Tirunellai, Ph. D. Senior Scientific Advisor, BPS, TPD November 22 and 24, 2016. bpsenquiries@hc …

https://capra.ca/_uploads/58824e351b51c.pdf

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Health Canada releases new guidance document on clinical …

(6 days ago) WEBOn November 15, 2022, Health Canada released a new guidance document, “ Guidance on clinical evidence requirements for medical devices.”. In it, …

https://www.smartbiggar.ca/insights/publication/health-canada-releases-new-guidance-document-on-clinical-evidence-requirements-for-medical-devices

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Health Canada: Guidance Document Management of Drug …

(9 days ago) WEBHealth Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).This guidance …

https://www.regulatoryaffairsnews.com/post/health-canada-guidance-document-management-of-drug-submissions-and-applications-post-din-changes

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Canada’s Guidance on Alcohol and Health - CCSA

(5 days ago) WEBCCSA proudly led the initiative to update Canada’s Low-Risk Alcohol Drinking Guidelines (LRDGs). The project, funded by Health Canada, began in July 2020. The two-and-a …

https://www.ccsa.ca/canadas-guidance-alcohol-and-health

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Canada’s vaccine advisory committee releases new guidance on …

(6 days ago) WEBCanada’s immunization advisory task force published new guidance on Friday that strongly recommends a fall COVID-19 shot for seniors, people with underlying …

https://www.theglobeandmail.com/canada/article-canadas-vaccine-advisory-committee-releases-new-guidance-on-covid-19/

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Health Canada increasing oversight of marketed drugs and …

(8 days ago) WEBYu Seon Gadsden-Chung. Health Canada recently proposed amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) to …

https://www.torys.com/en/our-latest-thinking/publications/2023/06/health-canada-increasing-oversight-of-marketed-drugs-and-medical-devices

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