Consultation on draft guidance document for Hospital-Based Mandatory Reporting Regulations (Vanessa’s Law)

You are invited to comment on a draft guidance document for the proposed amendments to the Food and Drug Regulations and Medical Device Regulations. These amendments would make it mandatory for hospitals to provide reports to Health Canada about:

• medical device incidents 
• serious adverse drug reactions

The proposal was published in the Canada Gazette, Part I on June 16, 2018.

Why

The guidance document gives information that may be useful in achieving compliance with the proposed new reporting requirement.

Who

This consultation is looking for feedback from all interested Canadians, in particular:

• hospital administrators
• biomedical engineers
• health care professionals

What

The consultation is looking for comments on:

• Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Hospitals – Draft guidance document

We are seeking advice and input on 3 questions:

• Are the descriptions and instructions in the guidance clear and detailed enough?
• Are the interpretations in the guidance administratively workable in a hospital setting?
• What other information is needed in order to understand the proposed regulations and what is required of those who have to report?

When and where

The consultation period runs until August 29, 2018.

How to participate

You may submit your comments and ideas about the guidance document by email to MHPD-DPSC.VL-LV@hc-sc.gc.ca.

Next steps

Feedback received on or before August 29, 2018, will be considered when we revise this draft guidance document.

Related information

Proposed amendments to the Food and Drug Regulations and Medical Device Regulations

Contact us

Office of Policy, Risk Advisory and Advertising
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9

Email: MHPD-DPSC.VL-LV@hc-sc.gc.ca