David Boudreau

strategic policy objectives for the MedTech sector regarding 2026 CUSMA review. export permits and export controls • Government investments in Artificial Intelligence (AI) compute infrastructure; • Government policy considerations on health data trust and privacy. Substances addressed in the third phase of the Chemicals Management Plan. Support from ISED, with respect to Strategic Innovation Fund Medical device cost recovery schemes with respect to filing fees Engage in pre-market and post-market regulatory requirements to ensure efficient and predictable processes that supports safety, effectiveness, quality, and Canada’s competitiveness in the medical device sector. Amendments to Copyright Act, regarding Technology Protection Measures (TPMs)

Policy and Programs Health Canada and Public Health Agency of Canada policies and programs to prevent and treat HIV and eliminate hepatitis as a public health threat by 2030, as part of Canada's commitments under the Global Viral Hepatitis Strategy and therapeutic efforts against the fight for COVID-19. Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations Patented Medicine Prices Review Board (PMPRB) Regulations with regard to reporting requirements, pricing, guidelines and dispute resolution. Innovation Agenda, particularly with respect to initiatives to support and attract investments in the life sciences sector Federal Government First Nations and Inuit Health Branch program with respect to health services. Federally-funded Public Drug Plans, with respect to reimbursement for drug products for federal plan beneficiaries. Canada Agency for Drugs and Technologies in Health (CADTH) as it relates to health economics assessment and recommendations made on new medicines.

Related to the life sciences, research and the digital ecosystems, we need to make sure that Canada creates an environment that is globally competitive Related to legislations on data privacy we need to make sure that Canada has legislations that are harmonized across provinces and federal governments as well as global standards. Patented Medicine Prices Review Board (PMPRB) amendments to the Patented Medicines Regulations and the related proposed guidelines.

Medical Device Regulations (SOR/98-282) that require compliance by the medical device technology industry. Addressing issues and providing advice related to Medical Device Regulations in Canada; performance of Therapeutic Products Directorate, Health Canada; other related activities of Health Canada e.g. health protection legislative renewal, cost recovery/user fees, quality systems (ISO 13485), single-use device reuse, Regulatory Review of Drugs and Devices (R2D2). Participate in the legislative/regulatory process with the intent of seeking reasonable approaches based on scientific evidence and changing policies where needed. Medical Device Bureau: discussions re. a program that assesses safety, effectiveness and quality of medical devices with respect to the authorization for the sale of medical device technologies in Canada. Innovation, Science and Economic Development Canada - advocating that the federal government work across all government relevant Ministries and with key stakeholders to advance the adoption of novel and innovative health innovations and grow the medical technology industry in Canada including forming a permanent cross ministerial and stakeholder collaborative roundtable/advisory group. Advocating for the development of a commercialization framework and adoption of medical technologies & health innovations strategy in Canada. Health Technology Assessment (HTA) - Providing advice and evidence related to the 'Value of Technology' in order to assist in the process of establishing proper medical device funding and reimbursement, contribution to the process of HTA with the intent of seeking reasonable approaches based on scientific evidence and changing reimbursement policies where needed. Health Canada - Health Technology Assessment (HTA) and the role of the Canadian Agency for Drugs and Technologies in Health (CADTH), GS1 (Global Standards 1) Canada, Vendor Credentialing, the removal of regulatory barriers to build an innovation economy and provide funding to grow a Canadian Artificial Intelligence & Digital Health cluster that will be globally competitive. Environmental regulation of Medical Devices (Canadian Environment Protection Act (CEPA), Chemicals Management Plan, provincial Stewardship regulations), Addressing issues and providing advice related to Medical Devices concerned by these regulations and participation in legislative/regulatory processes with the intent of seeking reasonable approaches based on scientific evidence and revising policies where needed. Discussions re. Policies to incent global medical technology companies to invest their R&D dollars in Canada, changes to the Scientific Research and Experimental Development tax credit and the impact on medical technology companies in Canada, the adoption of a common national framework to measuring health outcomes resulting in greater efficiencies and lower costs. Advancing the recommendations made by the Health & Biosciences Economic Strategy Table to grow the medical technology industry in Canada.

L'ordre en vertu du règlement sur les instruments médicaux (DORS!98-282) souhaite connaître sensibiliser Santé Canada à l'importance de bien réglementer l'utilisation de appareils auditifs en ventes libres homologués dans le but de mieux protéger la santé auditive des Canadiens et les Canadiennes.