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Health Canada Releases Paper on Mandatory Reporting SAEs and MDIs

  • June 28, 2017
  • News

Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions

Today Health Canada released a consultation paper on Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions inviting various stakeholders to comment on proposed changes to the Food and Drug Regulations and Medical Devices Regulations.  The development of this paper has been informed by consultations with provincial and territorial ministries of health, health professionals associations and the general public since March 2015. 

An information webinar on the consultation paper will be hosted by Health Canada on July 18th at 12:30.  To participate, please register via email by July 12th and provide your full name and email address.  The online consultation period runs from June 28 to August 17, 2017.

Important Information:

Summary

Consultation Paper

Issue Identification Paper

How to Participate:

  1. Your are encouraged to read the consultation paper for more information and enroll in the webinar session that will be held on July 18th. 
  2. Comments and ideas may be submitted by:

Health Canada Contact Information

Policy and International Affairs Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa   K1A 0K9 E
mail:  MHPD-DPSC.VL-LV@hc-sc.gc.ca