Medical Device Bureau, 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.
Regulation
Environmental regulation of Medical Devices (Canadian Environment Protection Act (CEPA), Chemicals Management Plan, provincial Stewardship regulations)
MEDEC Lobbying Action
Addressing issues and providing advice related to Medical Devices concerned by these regulations
Objective
Participation in legislative/regulatory process with the intend of seeking reasonable approaches based on scientific evidence and changing policies where needed
Health technology assessment
MEDEC Lobbying Action
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
Objective
Contribution to the process of health technology assessment with the intend of seeking reasonable approaches based on scientific evidence and changing reimbursement policies where needed
Medical Device Regulations (SOR/98-282) that require compliance by the medical device technology industry.
MEDEC Lobbying Action
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
Objective
Participation in legislative/regulatory process with the intend of seeking reasonable approaches based on scientific evidence and changing policies where needed