How to prevent missing future regulatory changes from Health Canada

How to Prevent Missing Future Regulatory Changes Video

Guidance Documents

Included below as additional resources are PDF versions of the Guidance Documents referenced within the video. They are also available on the Health Canada website.

Health Canada’s Medical Device Guidance Documents- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Health Canada’s Drug Products Guidance Documents- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

Guidance on Summary Reports and Issue-Related Analyses for Medical Devices

Guidance on Incident Reporting for Medical Devices

Guidance on Foreign Risk Notification for Medical Devices

Guidance on Amendments to the Food and Drugs Act: Guide to New Authorities

Resources for Identifying New and Revised Regulations

Google Alerts – Google Alerts is a web monitoring tool that will search for news articles and publications based on keywords that you assign. This requires a Google account and that you tailor the search criteria for the specific types of alerts you want to receive.

RAPS – The Regulatory Affairs Professionals Society publishes the RF Quarterly as well as other news related to regulatory affairs. Many of these publications are available without a RAPS membership, but members get the added benefit of emails when new publications are released as well as forum notifications.

ASQ – The American Society for Quality is another organization similar to RAPS that offers training and certification regarding quality and is another resource that keeps their fingers on the pulse of the regulatory world.

Health Canada eLearning Tool – Health Canada’s eLearning Tool often provides specialized training on topics related to new regulatory changes that they have introduced.

Health Canada Medical Devices RSS Feed – A subscription feed to manage and receive notifications when Health Canada publishes or releases new information related to medical devices.

Health Canada Drug Products RSS Feed -A subscription feed to manage and receive notifications when Health Canada publishes or releases new information related to drug products.

Health Canada What’s New – Medical Devices -An archived list of news releases and publications from Health Canada on medical devices and their regulations.

Health Canada What’s New – Drug Products – An archived list of news releases and publications from Health Canada on drug products and their regulations.

Health Canada List of Recognized Standards – A curated list of standards that Health Canada recognizes.

Medical Device Resources Page

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html

  • Activities
  • Application Information
  • Legislation & Guidelines – Medical Devices
  • Licenses
  • Quality Systems ISO 13485
  • Standards
  • Medical Device RSS Feed
  • Fees for Medical Devices
  • Projects
  • What’s New: Medical Devices
  • Medical Devices Action Plan – Stakeholder meetings and engagement activities
  • Medical device shortages: Overview
  • About medical devices
  • Vaginal surgical mesh: Overview
  • How to get accurate blood glucose meter readings
  • Covid-19: Personal protective equipment 3D printing and manufacturing
  • Good machine learning practice for medical device development: Guiding Principles