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The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include: [1] Prescription and non-prescription medications; Biologic medical products, including fractionated blood products; Therapeutic and diagnostic vaccines; Natural ...
The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health.
The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries. PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.
Health Canada (HC; French: Santé Canada, SC) [NB 1] is the department of the Government of Canada responsible for national health policy.The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others.
A national class action in Canada has been commenced against Medtronic Plc (NYSE: MDT) over its MiniMed 630G and 670G insulin pumps. Rochon Genova and Cardill Law commenced the proposed class ...
The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
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