The processes for reporting Serious Adverse Drug Reactions (ADRs) at Canadian Hospitals

At the DIA 2022 conference in Ottawa, Ms. Marie-Claude Brutus López, Coordinator, Canada Vigilance Regional Office, discussed Mandatory Reporting of Medical Device Incidents (MDIs) and Serious Adverse Drug Reactions (ADRs) by Hospitals. Below is a summary of main take-aways from your PV partners at Zenith PV.

Mandatory Reporting by Hospitals (MRH)

Dec 2022 marks the three years since the guideline came to effect. Since its implementation in 2019, there has been a modest increase in the number of reported MDIs and Serious ADRs by hospitals. However, the industry is still reporting on average 15x more ADRs and 8x more MDI reports compared to hospitals. There seems to be a need to address challenges to increase hospital compliance. This requires Health Canada to perform further promotion of the reporting framework including quality of reports, method of submission and timelines which are further discuss below.

Reporting Criteria

Serious ADR defined as: 

  • Noxious, unintended response to a drug at any dose causing:
  • Hospitalization or prolongation of existing hospitalization
  • Congenital malformation
  • Persistent or significant disability or incapacity threat to life, or death
  • Important medical event (as per medical judgement)

Medical Device Incidents (MDIs):

Related to:

  • The failure of a medical device
  • Deterioration in its effectiveness, or
  • Inadequacy in its labeling or directions

That led to:

  • The death or
  • Serious deterioration in health of a patient, user, or other person, or
  • Could do so were it to recur

Method of submission

Several methods of reporting are accepted by the Canada Vigilance Program namely:

  1. Electronic reporting
  2. Secure File Transfer Protocol (sFTP)
  3. Online: Through the ADR or MDI hospital online reporting application
  4. Fax or Mail

Download, print, complete and fax the ADR / MDI PDF form to 1-866-678-6789


Mail it to the Canada Vigilance Program


The guideline calls out for reporting within 30 calendar days of first documentation of the reaction or incident within the hospital


If your hospital requires support to increase its compliance to the MRH guidelines by Health Canada, Zenith PV can support you every step of the way. Contact us today at to get closer to 100% compliance.



Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Guidance document –

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