Consultation on draft guidance document for Hospital-Based Mandatory Reporting Regulations (Vanessa’s Law)
You are invited to comment on a draft guidance document for the proposed amendments to the Food and Drug Regulations and Medical Device Regulations.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.
The guidance document gives information that may be useful in achieving compliance with the proposed new reporting requirement.
This consultation is looking for feedback from all interested Canadians, in particular:
- hospital administrators
- biomedical engineers
- health care professionals
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- Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Hospitals – Draft guidance document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
Feedback received on or before August 29, 2018, will be considered when we revise this draft guidance document.
Office of Policy, Risk Advisory and Advertising
Marketed Health Products Directorate
Health Products and Food Branch
Address Locator 1912C
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