Forward Regulatory Plan 2019-2021: Regulations Amending the Food and Drug Regulations and Medical Devices Regulations - Recall of Therapeutic Products

Title of Regulatory Initiative

Regulations Amending the Food and Drug Regulations and Medical Devices Regulations - Recall of Therapeutic Products

Enabling Act

Food and Drugs Act

Description

The Protecting Canadians from Unsafe Drugs Act (also known as Vanessa's Law), received Royal Assent on November 6, 2014. This legislation, which amended the Food and Drugs Act, applies to therapeutic products including prescription and over-the-counter drugs, vaccines, gene therapies, cells, tissues and organs, and medical devices.

Since the passing of Vanessa's Law, the Minister of Health has the ability to remove a drug or medical device by ordering a recall when the product presents an imminent or serious risk to health.

Amendments to the Food and Drug Regulations and Medical Devices Regulations would introduce recall requirements and procedures for recalls.

This regulatory initiative was identified by Health Canada in its Health and Biosciences Sector Regulatory Review Roadmap.

This regulatory initiative is associated with Health Canada’s stock review plan.

Regulatory cooperation efforts (domestic and international)

This proposal would align Canadian requirements for medical device recalls with the U.S., which would support regulatory harmonization for medical devices under the Canada-United States Regulatory Cooperation Council.

Potential impacts on Canadians, including businesses

This proposal would improve the predictability and efficiency of recalls for industry as a result of clearer requirements and timelines. The proposal would also decrease the burden on industry relating to the reporting of low risk issues for medical devices.

Consultations

A Notice of Intent on the proposed regulatory amendments was published in June 2016 for a 30-day consultation period.

Heath Canada held four engagement sessions with various drug and medical device stakeholders in October 2016 which further informed the development of the proposal

Canadians will have the opportunity to provide further comments during the Canada Gazette, Part I public comment period, which is expected to take place in winter 2020 and last 75 days.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Catherine Hudon
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Health Canada

Telephone: 613-946-6220
Email: catherine.hudon@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2016

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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