Keeping health products in Canada safe From Health Canada 🇨🇦 Defines what health products are and how Health Canada continues to monitor them after authorization to ensure they are safe, effective and of high quality. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 2, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical device safety and use From Health Canada 🇨🇦 Medical device safety: From bandages to pacemakers, Health Canada ensures benefits outweigh risks, monitoring post-market use. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 30, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Transparency for machine learning-enabled medical devices: Guiding principles From Health Canada 🇨🇦 Guiding principles for good medical device machine learning practice developed by Health Canada, the US Food and Drug Administration and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada 🇨🇦 FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Updates to the list of recognized standards for medical devices and draft guidance: Notice From Health Canada 🇨🇦 Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Share your views: Updates made to list of recognized standards for medical devices and draft guidance From Health Canada 🇨🇦 Health Canada invites you to comment on proposed changes to the guidance on the list of recognized standards for medical devices Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations From Health Canada 🇨🇦 2006 Health Canada guidance document providing guidance for medical devices manufacturers on the use of standards in demonstrating compliance with the Safety and Effectiveness Requirements and Labelling Requirements of the Canadian Medical Devices Regulations Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 15, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device From Health Canada 🇨🇦 Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device. This guidance: • helps manufacturers determine when a change made to a device is significant • explains the concepts that manufacturers must apply when making this determination • provides many… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview From Health Canada 🇨🇦 Summary of guidance for hospitals about achieving compliance with federal regulatory requirement to report serious ADRs and MDIs to Health Canada. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 18, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guide to authorities under the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law): Overview From Health Canada 🇨🇦 The Amendments to the Food and Drugs Act: Guide to New Authorities was developed to help Health Canada implement the new authorities that came into force upon royal assent of Bill C-17, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 8, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
The Health Canada eSTAR pilot program From Health Canada 🇨🇦 eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 13, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Health Canada and FDA eSTAR pilot: Notice to industry From Health Canada 🇨🇦 eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 13, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Notice on Proposed changes to the Medical Devices Regulations to address future public health emergencies From Health Canada 🇨🇦 Notice on Health Canada's proposed regulatory amendments to expand the Medical Devices Regulations beyond COVID-19 medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 23, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance Document: Software as a Medical Device (SaMD): Classification Examples From Health Canada 🇨🇦 This document is intended to clarify how Software as a Medical Device (SaMD) fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Notice to industry: Medical devices contained in electronic health record (EHR) products From Health Canada 🇨🇦 This notice is for manufacturers of EHR software products and EHR-based medical devices. Through this notice, Health Canada wants to remind manufacturers of their regulatory obligations for EHR-based medical devices in Canada. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 31, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Health Canada launches electronic manufacturer's certificate to export From Health Canada 🇨🇦 Medical devices establishment license bulletin outlining the launch of an electronic version of the manufacturer's certificate to export Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 4, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Draft Guidance Document: Applications for Medical Device Investigational Testing Authorizations From Health Canada 🇨🇦 This draft guidance document reflects Health Canada’s current thinking on Investigational Testing Authorizations (ITA) for medical devices and may be subject to changes as policy develops. The document clarifies application requirements and processes, including pre-ITA meetings, format for an ITA… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 18, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance Document: Medical Device Licence Renewal and Fee for the Right to Sell Licensed Medical Devices From Health Canada 🇨🇦 2013 Health Canada guidance document Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 24, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Preparation of an Application for Investigational Testing - In Vitro Diagnostics Devices From Health Canada 🇨🇦 Cover letter of a 1999 Health Canada Guidance document Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Notice - Publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices and related documents From Health Canada 🇨🇦 Health Canada is pleased to announce the publication of the Regulations Amending the Medical Devices Regulations - Non-Corrective Contact Lenses and Labelling of Class II Medical Devices, in Canada Gazette, Part II and the release of the final guidance documents and application forms. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites