Forward Regulatory Plan 2019-2021: Modernizing Drug and Medical Device Establishment Licensing Frameworks – Amendments to the Food and Drug Regulations and Medical Devices Regulations

Title of Regulatory Initiative

Modernizing Drug and Medical Device Establishment Licensing Frameworks – Amendments to the Food and Drug Regulations and Medical Devices Regulations

Enabling Act

Food and Drugs Act

Description

The proposed regulatory amendments would replace burdensome annual review requirements with less prescriptive and more flexible provisions on establishment licences, and streamline the review process for issuing and reviewing establishment licences by reducing the amount of information required to be submitted. The proposed amendments would also introduce terms and conditions for medical device establishment licences and create new exemptions for start-up companies under certain conditions.

This proposal would extend the drug establishment licensing framework to exporters and require persons manufacturing higher risk medical devices for export to register with Health Canada.

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)

Modernizing Canada's regulatory requirements for exports and goods in transit would contribute to meeting Canada's obligations under the Canada-European Union Comprehensive Economic Trade Agreement (CETA) and the World Trade Organization Trade Facilitation Agreement (WTO-TFA).

This proposal also addresses Canada's Economic Strategy Tables recommendations to adopt requirements that align with international best practices.

Potential impacts on Canadians, including businesses

This proposal is expected to increase regulatory decisions-making efficiency and predictability in relation to drug establishment licences. Revised approaches would better support new and innovative medical devices companies by allowing them to begin operations sooner.

This proposal would maintain Canada's international reputation as a country exporting good quality drugs and medical devices which would create a level playing field for Canada's pharmaceutical and medical device sectors.

Consultations

It is anticipated that Canadians will have the opportunity to provide further input 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, 2018

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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