Medical Devices Action Plan – stakeholder meetings and engagement activities
The federal government is committed to providing Canadians with more opportunities to learn about and participate in government. In keeping with this commitment to openness and transparency, Health Canada has issued a notice outlining how it will manage the information provided by stakeholders for specific initiatives, including the Medical Devices Action Plan (MDAP). The following table is part of this initiative.
This table presents correspondence and meetings with stakeholders in which views, opinions and information were relayed with the intent to inform and influence the development of policies, guidance or regulations related to the MDAP. Please note that this table will be updated on a monthly basis and that information requests related to the MDAP are not included.
The documents listed in the table are available to the public upon request. If a Health Canada document is listed in only one of the two official languages and you would like to have a copy in English or French, please indicate this in your application. However, note that documents, hyperlinks or information provided by individuals or organizations are not subject to the Official Languages Act; consequently, in some cases, these documents may only be available in one of the official languages in which they have been submitted.
To request a copy of a document listed in the table, send your request by email to firstname.lastname@example.org, clearly indicating the date and number of the document.
|Date||Topic||Organization||Type of Interaction||Purpose||Health Canada Office||Document(s) Shared|
|2018-04-10||Part III: Provide More Information To Canadians||Health Canada, various drug and medical device manufacturers, health professionals, academic researchers, and patient organisations||Health Canada-Initiated Meeting||Public Consultation on Draft Guidance for the Public Release of Clinical Information, April 10 to June 25, 2018||Resource Management and Operations Directorate||
|2018-04-26||Part III: Provide More Information To Canadians||MEDEC||Stakeholder-Initiated Meeting||Discuss MEDEC comments on draft Public Release of Clinical Information regulations||Resource Management and Operations Directorate||MEDEC presentation, “Clinical Data Transparency for Medical Devices – Health Canada Meeting” April 26, 2018|
|2018-11-30||Part II: Strengthen Monitoring And Follow-up||Yukon Type 1 diabetes Support Network||Stakeholder-Initiated Correspondence||Response letter to medical device concerns||Marketed Health Products Directorate||Letter to Health Canada|
|2018-11-30||Part III: Provide More Information To Canadians||Women’s College Hospital/ University of Toronto||Stakeholder-Initiated Correspondence||To discuss Government’s response to medical device issues||Therapeutic Products Directorate||Letter to Health Canada|
|2018-12-05||Part I: Improve How Devices Get On The Market||GS1 Canada||Stakeholder-Initiated Correspondence||To request a meeting on the use of Global Standards||Therapeutic Products Directorate||Letter to Health Canada|
|2018-12-10||Part I: Improve How Devices Get On The Market||Ottawa Hospital||Stakeholder-Initiated Correspondence||To discuss ways in which the Ottawa Hospital could assist the Therapeutic Products Directorate in meeting its mandate of protecting the safety of patients||Therapeutic Products Directorate||Letter to Health Canada|
|2018-12-21||Part I: Improve How Devices Get On The Market||Health Canada with industry, healthcare and patient stakeholders||Stakeholder-Initiated Meeting||To provide information to medical device stakeholders on the Medical Devices Action Plan||Therapeutic Products Directorate||
|2019-01-13||Part II: Strengthen Monitoring And Follow-up||Canadian Heart Rhythm Society||Stakeholder-Initiated Correspondence||Discuss a national registry of implanted cardiac devices||Marketed Health Products Directorate||Op-ed Device Advisories|
|2019-01-28||Part I: Improve How Devices Get On The Market||Health Canada with industry, healthcare and patient stakeholders||Health Canada-Initiated Meeting||To provide information to medical device stakeholders on the Medical Devices Action Plan||Therapeutic Products Directorate||
|2019-02-20||Part II: Strengthen Monitoring And Follow-Up||Type 1 Together||Stakeholder Initiated Correspondence||To request clarity on details of latest Information Update entitled "Health Canada encourages Canadians to report incidents involving medical devices to help strengthen patient safety" as well as to ask specific questions related to reporting and recalls for diabetic medical devices||Regulatory Operations and Enforcement Branch||Letter to Health Canada|
|2019-03-22||Part II: Strengthen Monitoring And Follow-Up||Stakeholder-Initiated Meeting||To share women's experiences related to breast implants and to discuss patient perspectives||Marketed Health Products Directorate|
|2019-05-03||Part I: Improve How Devices Get On The Market||Les Ameshées (French-Canadian women's support group)||Stakeholder Initiated Meeting||To share women's experiences related to polypropylene surgical mesh implants for the treatment of stress urinary incontinence (SUI) and to foster an exchange between Health Canada and the Ameshées on: their concerns regarding the risks related to the surgical mesh; Health Canada's role in licensing this medical device; the Department's monitoring and follow-up once the device is approved for sale; and Health Canada's authority to remove a medical device from the Canadian market.||Therapeutic Products Directorate||
|2019-06-21||Part III: Provide More Information To Canadians||Health Canada-Initiated Meeting||
To share women's experiences related to breast implants (BI); discuss patient perspectives; present comments and recommendations on educational materials for BI; and, request that:
|Marketed Health Products Directorate||
|2019-06-26||Part III: Provide More Information To Canadians||Health Canada-Initiated Meeting||
Webinar for healthcare professionals to discuss and respond to questions regarding Health Canada's safety review of breast implants-associated anaplastic large cell lymphoma (BIA-ALCL)
|Therapeutic Products Directorate|
|2019-12-02||Part I: Improve How Devices Get on the Market||Health Canada||Health Canada-initiated Correspondence||Targeted stakeholder consultation on potential regulatory amendments to Part 3 (Investigational Testing Authorizations) of the Medical Devices Regulations||Therapeutic Products Directorate||Discussion document on Consultation on Medical Device Investigational Testing Authorizations (ITAs)|
|2020-01-16||Part I: Improve How Devices Get on the Market||Mesh. Canada (meeting with the patient group representative)||
The objectives of the meeting were:
2) To present the current situation at Health Canada regarding the approval and monitoring of surgical mesh used for hernia repair.
|Medical Devices Directorate||BBC News Article (2020-01-15): Hernia mesh implants used 'with no clinical evidence'|
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