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Notice: Medical Device Cybersecurity August 15, 2018 Reference Number: 18-108099-160 Introduction In recent years, there has been a dramatic increase in the level of interconnectedness and data exchange between medical devices and their network environments. Increased…

Scientific Advisory Committee on Digital Health Technologies (SAC-DHT) Meeting Announcement Ottawa, Ontario June 7, 2018 Background Given the fast pace of innovation in digital health technologies, specifically in relation to medical devices, Health Canada is undertaking an…

Notice of intent: Strengthening the post-market surveillance and risk management of medical devices in Canada This Notice of Intent is to inform stakeholders, notably manufacturers and importers of medical devices, of our intent to propose regulatory changes to strengthen the…

Public Release of Clinical Information - Draft Guidance Document Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on…

Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology Notice to Interested Parties Objective This Notice of Intent serves to solicit comments on possible changes to the Food and Drug Regulations around establishing pharmaceutical…

Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations Effective immediately, the option for aligned reviews is available to all biological and pharmaceutical new drug submissions. This includes: biosimilars supplemental new drug…

Australia Canada Singapore Switzerland (ACSS) Consortium – Erleada approval July 13, 2018 Our file number: 18-108470-709 On July 4, 2018 Health Canada approved the first drug to be evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium’s New Chemical…

Notice: Device Advice: Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada March 19, 2019 Our file number: 19-101967-390 Under the Regulatory Review of Drugs and Devices initiative, Health…

Notice to Industry: Health Canada and CADTH launch new initiative to provide early parallel scientific advice Improving Access to Medicines Health Canada's Regulatory Review of Drugs and Devices (R2D2) initiative aims to provide more timely access to medicines for Canadians.…

Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients Current status: Closed This consultation ran from April 8, 2019 to June 17, 2019. Health Canada is proposing amendments to the Food and Drug…