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Updated and new draft Health Canada guidance documents …

On August 30, 2023, Health Canada opened consultation on its draft pre-market guidance for machine learning-enabled medical devices (MLMD), i.e., medical devices that use machine learning, in whole or in part, to achieve their intended medical purpose.The guidance assists manufacturers who submit an application for an MLMD, outlines expectations for demonstrating the safety and effectiveness

Actived: 9 days ago

URL: https://www.smartbiggar.ca/insights/publication/updated-and-new-draft-health-canada-guidance-documents-related-to-medical-devices

Health Canada paving the way for more AI/ML medical devices

WebThe document consists of 10 guiding principles to help promote safe, effective, and high-quality use of artificial intelligence and machine learning (AI/ML) in …

Category: Health Go Health

Updates to Health Canada’s regulatory initiatives for 2022-2024, …

WebHealth Canada has updated its Forward Regulatory Plan: 2022-2024, providing information on regulatory initiatives Health Canada aims to propose or finalize …

Category: Health Go Health

Health Canada Consultation on Electronic Media in Prescription …

WebMarch 31, 2021. On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft …

Category: Health Go Health

Update on biosimilars in Canada – March 2023

WebDecember 20, 2022 – Ontario announced that patients receiving coverage from the Ontario Drug Benefit will transition to biosimilars, subject to exemptions, …

Category: Health Go Health

Update on biosimilars in Canada

WebSince our last update in August 2020, Health Canada approved 11 biosimilars of 5 innovator products. This includes approval of 2 biosimilars of 2 innovator …

Category: Health Go Health

Update on biosimilars in Canada – August 2020

WebAccording to Health Canada’s annual report, revised September 1*, Health Canada approved eight biosimilar submissions in the 2019/2020 fiscal year, which runs …

Category: Health Go Health

First year of Project Orbis leads to 38 approvals of cancer therapies

WebAccording to a recent publication by the Project Orbis partnership, the program received 60 oncology marketing applications in the first year, resulting in 38 …

Category: Health Go Health

COVID-19 Update: CIPO, Federal Courts, Health Canada

WebThe Federal Court dismissed Merck’s judicial review application of the Minister’s decision that the 30-day time limit under s. 4 (6) for submitting a patent list was …

Category: Health Go Health

Update on biosimilars in Canada – June 2022

WebAuthored by Urszula Wojtyra. June 28, 2022. Update: Biosimilars in Canada – March 2023 is available to view online. We provide a further update on developments …

Category: Health Go Health

Health Canada issues interim policy re: interpretation of “medicinal

WebThe Interim Policy states: Following the court's decision and for regulatory consistency, Health Canada has reassessed its interpretation of "medicinal ingredient" …

Category: Health Go Health

Update on biosimilars in Canada – March 2024

WebOn March 29, 2023, the Government of Yukon announced the Yukon Biosimilar Initiative. The first phase switched patients taking adalimumab and insulin …

Category: Health Go Health

Health Canada amends Drug Sampling Laws and issues Guidance …

WebAs mentioned, under the amendments (1) certain low-risk NHPs will be treated like certain low-risk OTC DIN drugs with respect to direct sampling to consumers; …

Category: Health Go Health

Patentability of diagnostic methods – has the Canadian Patent …

WebUntil recently, the Canadian Patent Office drew a distinction between a diagnostic method that “solves a data acquisition problem” and one that “solves a data …

Category: Health Go Health

Final regulations addressing the public release of clinical …

WebOn March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices …

Category: Food, Medical Go Health

Proposal by Health Canada on Review of Look-alike Sound-alike …

WebIn our September 2003 issue of Rx IP Update, we reported that Health Canada presently reviews drug names on an informal basis, but that consultations …

Category: Health Go Health

On the (Quebec Health) Record: the Federal Court holds the …

WebToday’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP. Our highly skilled team of lawyers, patent …

Category: Health Go Health

Ontario Ministry of Health proposes regulatory amendments …

WebOn October 19, 2023, the Ontario Ministry of Health proposed regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability …

Category: Health Go Health

Natural and Non-Prescription Health Products Directorate

WebNatural and Non-Prescription Health Products Directorate Drug Submission Performance Annual Report Fiscal Year 2020-2021 April 1 2020 - March 31 2021

Category: Health Go Health

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