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Medical Devices Action Plan – stakeholder meetings and engagement activities

A Progress report for Medical Devices Action Plan was published in May 2021.

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 meddevices-instrumentsmed@hc-sc.gc.ca, clearly indicating the date and number of the document.

Learn more about how Health Canada makes information, data, publications and reports available to Canadians.

Table: Medical Devices Action Plan – stakeholder meetings and engagement activities
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professionals, academic researchers, and patient organisations Health Canada-Initiated Meeting Public Consultation on Draft Guidance for the Public Release of Clinical Information, April 10 to June 25, 2018 Resource Management and Operations Directorate
  1. Draft Guidance document – Public Release of Clinical Information
  2. Summary of stakeholder comments (English)
  3. Individual submissions from stakeholders
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
  1. Medical Devices Action Plan
  2. Discussion paper
  3. Presentation slides
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
  1. Medical Devices Action Plan
  2. Discussion paper
  3. Presentation slides
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
  1. « Je suis l'Ameshée : Portrait de 200 femmes blessées par la chirurgie avec treillis de mailles transvaginales » (2019), Les Ameshées.
  2. « L'incontinence à l'effort » (2014), Dépliant de l'Association des urologues du Canada.
  3. « Le chemin de la guérison après la chirurgie transvaginale de la perforation du maillage de l'urètre: évaluation des résultats et des procédures ultérieures » (2018), Kowalik C.G. et al., Journal international d'urogynécologie.
  4. « Autoinflammatory / autoimmunity syndrome induced by adjuvants (ASIA; Shoenfeld's syndrome) : A new Flame » (2018), Tervaert, J.W.C., Autoimmunity Reviews
  5. « Autoinflammatory / autoimmunity syndrome induced by adjuvants (Shoenfeld's syndrome) in patients after a polypropylene mesh implantation » (2019), Tervaert, J.W.C., Best Practice & Research Clinical Rheumatology.
  6. « Résultat à long terme de la procédure de ruban transobturateur sous-urétral pour le traitement de l'incontinence urinaire à l'effort chez la femme » (2014), El-Eweedy S. M. et al., Urology Annals.
  7. « Facteurs influant sur la déclaration d'événements indésirables liés aux dispositifs médicaux : entretiens qualificatifs avec des médecins sur les dispositifs implantables à risque élevé », Gagliardi A. R et al.
  8. Compte rendu - Rencontre entre Santé Canada et le groupe de soutien-Les Améshées (Bandelette d'incontinence urinaire) - 2019-05-03 (VF)
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:

  • The labelling of implantable medical devices becomes more comprehensive and includes all ingredients incorporated in the composition of a device (e.g. chemicals, metals, etc.);
  • Health care providers be informed on Breast Implant Illness and trained on how to diagnose this illness;
  • Health Canada requires doctors to provide patients with a physical copy of an informed consent document (booklet) well in advance of their BI surgery, and that this document be standardized and created by a neutral party;
  • Breast implant illness advocates be included in the Scientific Advisory Committee on Health Products for Women (SAC-HPW) when BI issues are discussed;
  • Health Canada improves its website to make it more user-friendly and to also facilitate voluntary reporting of medical device problems
 Marketed Health Products Directorate
  1. Counter-Response to Minister of Health re Petition NO.: 421-03410 Medical Devices (2019-06-14), Judith Coates (Breast Implant Illness Advocate -Breast Reconstruction Patient Advocate) / on behalf of Canadian women affected by Breast Implant Illness & BIA-ALCL, the Canadian Advocacy Team for Breast Implant Failure & Illness.
  2. PowerPoint Presentation of women's experiences (2019-06-19).
  3. « Finding the fit that's right for you - Your Surgery Planner - For Breast Augmentation Surgery with NATRELLE®Gel-Filled Breast Implants » (2018), Allergan, 92 pages
  4. « Training and Education Improvement » (2019-06-19), Breast Implant Lymphoma Advocates / Breast Implant Illness Advocates
  5. « Objet : Avis préventif - Implants mammaires textures » (2019-04-02), Lettre du Gouvernement du Québec
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)
See: Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated anaplastic large cell lymphoma)

 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)

Stakeholder-Initiated Meeting

The objectives of the meeting were:
1) To develop a greater understanding of the patient perspective on complications related to the use of surgical mesh implants for hernia repair, and

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'
2020-07-16 Part I: Improve How Devices Get On The Market Medtech Canada Health Canada-Initiated Meeting

The purpose of the meeting organized by Health Canada was to present the Medical Devices Directorate’s (MDD) consultation plan and to receive comments and feedback on the proposed plan.

The MDD Consultation Plan – 2020-2021 includes consultation activities related to the Medical Devices Action Plan, in particular consultations on:

  • Clinical evidence requirements for medical devices;
  • Unique device identification system for medical devices;
  • Post market requirements for medical device cybersecurity;
  • Requirements for medical devices that contain static artificial intelligence/machine learning algorithms.
 Medical Devices Directorate Medical Devices Directorate Consultation Plan – 2020-2021
2020-07-17 Part I: Improve How Devices Get On The Market Les Ameshées (Support group for francophone women in Canada suffering from complications related to the use polypropylene surgical mesh for the treatment of urinary incontinence) Health Canada-Initiated Meeting

The conference call between the president of the patient group les Ameshées and Health Canada was organized to provide an update on the department's activities in regards to polypropylene surgical mesh for the treatment of urinary incontinence:

  • Health Canada has initiated a safety and effectiveness review of polypropylene surgical mesh for the treatment of urinary incontinence. The review will take into consideration the Rapport d’enquête du Collège des médecins du Québec, incidents reported to Health Canada, a literature review, as well as consultations with Canadian professional associations (obstetricians, gynaecologists and urologists) and manufacturers. Health Canada expects to complete its evaluation by late fall 2020.
 Medical Devices Directorate Rapport d’enquête du Collège des médecins du Québec - Les complications liées à la mise en place d’une bandelette sous-urétrale (Juin 2020) (available in French only)
2020-07-20 Part I: Improve How Devices Get On The Market Canadian Council of Innovators (CCI) Health Canada-Initiated Meeting

The purpose of the meeting organized by Health Canada was to present the Medical Devices Directorate’s (MDD) consultation plan and to receive comments and feedback on the proposed plan.

The MDD Consultation Plan – 2020-2021 includes consultation activities related to the Medical Devices Action Plan, in particular consultations on:

  • Clinical evidence requirements for medical devices;
  • Unique device identification system for medical devices;
  • Post market requirements for medical device cybersecurity;
  • Requirements for medical devices that contain static artificial intelligence/machine learning algorithms.
 Medical Devices Directorate Medical Devices Directorate Consultation Plan – 2020-2021

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