Forward Regulatory Plan 2019-2021: Exemptions for certain Digital Health Software

Title of Regulatory Initiative

Exemptions for certain Digital Health Software

Enabling Act

Food and Drugs Act

Description

Health Canada is proposing to amend the Medical Devices Regulations.

The proposed regulatory amendments will exempt certain digital health software from current regulatory requirements.

This is a long-term regulatory initiative for which Health Canada is targeting 2023 to publish amendments in the Canada Gazette, Part ll.

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

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

Regulatory cooperation efforts (domestic and international)

The proposed approach would align with similar changes introduced in the United States.

Potential impacts on Canadians, including businesses

The proposal would reduce reporting burden on industry related to low-risk issues for medical devices.

Consultations

Canadians will have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2022 and last 70 days.

Further information

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

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

May 27, 2019

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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