Communicate with government on behalf of members, regarding the impact of changes to Canada-US Trade agreements, as they apply to medical technologies. Following Royal Assent of Bill C-244, An Act to Amend the Copyright Act (diagnosis, maintenance and repair), monitor development of a right to repair framework and its potential impact on the medical device industry. Communicate with government potential regulatory measures to protect patient safety as a consequence of Bill C-244 and future policies and/org legislation regarding right to repair. Establishment of a Diabetes Fund for medical devices associated with diabetes management. Monitor and participate in discussions to advance and support digital health and data. 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 Development of policies that will improve the market in Canada for innovative medical technologies. C-244 An Act to amend the Copyright Act (Diagnosis, Maintenance and Repair Gain information on the potential impacts for the medical device industry and given any patient safety concerns, seek relevant amendments.
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.