00000nam 2200000zi 4500 9.873314 CaOODSP 20251125102931 m o d f cr cn||||||||| 190521t20202020onc ob f000 0 eng d 9780660309828 CaOODSP eng rda CaOODSP n-cn--- H14-327/2019E-PDF Risk classification guide for medical device establishment inspections. Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (28 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Guide de classification des risques pour les inspections d'établissements d'instruments médicaux. "GUI-0079." "January 31, 2020." "Archived"–Health Canada, 7 November 2025. Issued also in HTML format. Includes bibliographical references (pages 27-28). "This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when: classifying observations of deviations, deficiencies or failures according to risk; assigning an overall compliance rating to an inspection. It also informs anyone with a medical device establishment licence (MDEL) of the situations Health Canada considers unacceptable that may result in a non-compliant (NC) rating and/or compliance and enforcement actions"--page 5. Medical instruments and apparatus Safety regulations Canada. Canada. Health Canada, issuing body. Guide de classification des risques pour l'inspection des établissements de instruments médicaux. (CaOODSP)9.873316 PDF 1.46 MB https://publications.gc.ca/collections/collection_2020/sc-hc/H14-327-2019-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-risk-classification-medical-device-observations-0079.html 190053