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Cells, Tissues and Organs - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 249991
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Cells, Tissues and Organs - Canada.ca
2 janv. 2026
hc-20260101
ID 428853
updated2 sections changed
2 sections modifiées0 ajoutées0 retirées+0 / -6 lignesVariation: 10%
--- +++ @@ -4,11 +4,6 @@ (CTO Regulations or Regulations) contain safety requirements with respect to processing; storage; record keeping; distribution; importation; error, accident and adverse reaction investigation and reporting. Processing includes donor screening, donor testing, donor suitability assessment, retrieval (except in the case of organs and islet cells), testing and measurements performed on the cells, tissues or organs (CTO) after they are retrieved, preparation for use in transplantation (except for organs), preservation, quarantine, banking, packaging and labelling. These Regulations are intended to result in improved protection of the health and safety of Canadian transplant recipients The CTO Regulations require that source establishment and establishments that distribute or import cells, tissues or organs register with Health Canada. Establishments that only retrieve CTO, only import for transplant, or only transplant do not have to register. Furthermore, based on the CTO Regulations, source establishments are to report to Health Canada suspected errors and accidents that are identified after distribution of CTO that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent, or an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent. The error and accident preliminary investigation report form is provided below.-Reports-Summary Report of Inspections of Cells, Tissues and Organs Establishments Conducted from August 2009 to June 2012-[2013-01-16]-Summary Report: Stakeholder Consultation Workbook for the Cells, Tissues and Organs (CTO) Programs Inspection Strategy-[2012-11-21] Regulations Safety of Human Cells, Tissues and Organs Regulations (CTO Regulations)@@ -28,5 +23,4 @@ Compliance Promotion Thinking about banking your child’s cord blood? Page details-Date modified: 2023-09-25