Search results
The Canada Gazette website
- : “In Canada, all proposed regulations are posted on the Canada Gazette website for public consultation.”
canadagazetteducanada.gc.ca/consult/consult-eng.html
People also ask
Where are proposed regulations posted in Canada?
Can I comment on proposed regulations published in the Canada Gazette?
What will the proposed Proposed Regulations mean for Canada’s oil industry?
How do I comment on proposed regulations?
What are Canada's Regulatory roadmap initiatives?
How much did the government of Canada spend on regulatory roadmaps?
Federal departments and agencies allow interested groups, individuals, and Canadians to review and comment on proposed regulations published in Part I of the Canada Gazette before they become official. You can comment on proposed regulations found in the open consultations section of this page.
- Canada Gazette, Part 2, Volume 154, Number 26: Regulations ...
The proposed Regulations were prepublished in the Canada...
- Canada Gazette, Part 2, Volume 154, Number 26: Regulations ...
You can learn about new statutes, new and proposed regulations, administrative board decisions and public notices. Find out how government departments, businesses and other Canadian organizations can publish their public notices
Since 2018, six Regulatory Roadmaps (plans of action) have been published, identifying over 100 concrete actions from 14 departments and agencies to: support regulatory modernization. respond to stakeholder issues and irritants. advance novel regulatory approaches.
The proposed regulations were published in the Canada Gazette, Part I, on November 14, 2020 for a 60-day public comment period. The publication of the final regulations in the Canada Gazette , Part II, is targeted for fall 2021.
- Issues
- Background
- Objectives
- Description
- Regulatory Development
- Regulatory Analysis
- Implementation, Compliance and Enforcement, and Service Standards
- Contact
Health Canada (the Department) has the authority to regulate the safety, efficacy and quality of drugs and the safety, effectiveness and quality of medical devices. Health Canada's authority is derived from the Food and Drugs Act (FDA), and its associated regulations, theFood and Drug Regulations (FDR) and the Medical Devices Regulations(MDR). Heal...
Vanessa's Law provisions that require supporting regulations
The amendments to the FDA through Vanessa's Law strengthen Health Canada's ability to collect post-market safety information and take appropriate action in situations where a serious risk to health is identified. While several amendments came into force immediately (e.g. the power to recall unsafe therapeutic products, the power to compel label changes and the possibility of tougher fines and penalties for contraventions), other powers require regulations to clarify their scope. These include...
Regulations to improve post-market surveillance
Amendments to the MDR are necessary to implement summary reports, a post-market vigilance tool that is lacking for medical devices. Similar reporting obligations are a requirement of the 2017 European Commission regulations for medical devices that will be fully implemented for most devicesfootnote 5by May 26, 2021. Implementation of the European regulations was originally intended to take place by May 26, 2020, but was postponed by one year due to the COVID-19 pandemic. The addition of such...
Removing unnecessary burden: revising the reference to quality standards
The MDR require that medical device manufacturers provide copies of a quality management certificate to certify that they comply with the specified International Organization for Standardization (ISO) standard set out in the application section of the Regulations (section 32). Because the ISO standard is specifically mentioned in the Regulations by name, the Regulations must be amended each time the ISO standard changes. Given the global nature of medical device manufacturing and widespread u...
The objectives of the regulatory amendments are to 1. (1) operationalize the powers included in Vanessa's Law to require assessments, tests and studies by establishing the rules needed to structure the exercise of those powers for medical devices; 2. (2) support post-market medical device safety by creating new rules for reporting actions in foreig...
Vanessa's Law provisions that require supporting regulations
These regulatory amendments add provisions to the MDR to support sections 21.31 and 21.32 of Vanessa's Law so as to fully operationalize the Minister's authority to order medical device licence holders to conduct an assessment, collect information, conduct additional tests and studies, and/or monitor experience. The Regulations will apply to medical device licence holders for Class II, III and IV medical devices. They will not apply to establishment licence holders for Class I medical devices...
Regulations to improve post-market surveillance
The Regulations will be amended to require medical device licence holders (i.e. manufacturers of Class II, III and IV devices) to: (1) review the information they received under the Regulations or became aware of during either the previous 24 months (in the case of Class II devices), or the previous 12 months (in the case of Class III and IV devices), about the medical device related to 1. adverse effects; 2. reported problems; 3. incidents; and 4. risks; (2) prepare a summary report. In prep...
Removing unnecessary burden: revising the reference to quality standards
Section 32 of the MDR will be amended to provide an ambulatory incorporation by reference to the ISO document that addresses quality management systems for medical devices.
Consultations
Health Canada has engaged stakeholders extensively since 2010 to understand their various positions on the concepts underlying Vanessa's Law. For example, Health Canada hosted a series of three technical discussions with stakeholders in late 2010 and early 2011 on regulatory modernization and regulating drugs and medical devices based on a life cycle approach. These discussions covered topics such as terms and conditions, tests and studies, suspension, and revocation. Many of these components...
Modern treaty obligations and Indigenous engagement and consultation
Indigenous peoples are not expected to be disproportionately impacted by these regulatory amendments.
Instrument choice
Health Canada considered regulatory and non-regulatory options including: Vanessa's Law order powers under sections 21.31 (to require assessment) and 21.32 (to require tests and studies) of the FDA are not currently being used for medical devices. Regulations are required to clarify the circumstances and scope of the power that the Minister may exercise in orders made pursuant to sections 21.31 and 21.32. The existing requirements specifying the content of the incident reports (subsection 60(...
Benefits and costs
An analysis of the reported costs and benefits determined that the Regulations will have a low-cost impact on the medical device industry. This section provides a description of the methodology used in the analysis, a quantitative depiction of costs and a qualitative listing of potential direct benefits due to the regulatory package. Table 1 outlines the incremental costs to industry should it be required to report on an incident involving a medical device under either of the two regulatory a...
Small business lens
Primarily based in Ontario, Quebec and British Columbia,footnote 10 Canada's medical device sector is comprised of approximately 1 500 companies, employing 35 000 people;footnote 11 the sector is dominated by small and medium-sized enterprises (SMEs).footnote 10 Over half of its companies (57%) have fewer than 25 employees and 37% have 25 to 49 employees. Only 4% of companies hire 50 to 150 employees and fewer than 1% have more than 150 employees.footnote 12 Nearly 90% of the medical device f...
One-for-one rule
The Regulations include two provisions that would add new regulatory burden and one provision which would remove burden. The provisions will be a net “OUT” of regulatory burden for Canadian firms. The entirety of the cost calculations represents an administrative burden due to the additional reporting requirements. Administrative burden calculations are aggregated from survey responses, and mean values are used in order to develop cost-per-activity figures. The average wage is $58 per hour, w...
These amendments will not alter existing compliance and enforcement mechanisms under the provisions of the Act and the MDR. For example, if a manufacturer were to refuse to comply with an assessment order, the Minister could seek an injunction or recommend prosecution, which could result in the imposition of fines and penalties. Health Canada inten...
Bruno Rodrigue Executive Director Office of Legislative and Regulatory Modernization Policy, Planning and International Affairs Directorate Health Products and Food Branch Health Canada Holland Cross, Suite 14 11 Holland Avenue Ottawa, Ontario K1A 0K9 Address locator: 3000A Email: hc.lrm.consultations-mlr.sc@canada.ca
Canadian Firearms Program. Date modified: 2024-01-22. With communities across the country facing a steady increase in gun violence over the past five years, the Government of Canada is strengthening Canada's gun laws in a common-sense, focused and effective way. Legislation introduced prioritizes public safety and effective police work, while ...
May 28, 2024 · To learn about upcoming or ongoing consultations on proposed federal regulations, visit: Consulting with Canadians. Canada Gazette. Previous. Table of Contents. Next. Date modified: 2024-05-28.
