00000nam 2200000zi 4500 9.897561 CaOODSP 20250218133632 m o d f cr cn||||||||| 210316e20210317onc o f000 0 eng d 9780660379364 CaOODSP eng rda CaOODSP n-cn--- H14-353/2021E-PDF COVID-19 guidance for reporting medical device shortages. COVID-19 guidance for reporting medical device shortages (GUI-0137) Ottawa, ON : Health Canada = Santé Canada, March 17, 2021. ©2021 1 online resource (19 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur la déclaration des pénuries d'instruments médicaux dans le cadre de la pandémie de COVID 19. "GUI-0137." "Pub.: 200482." Issued also in HTML format. "This guidance document supports Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (Interim Order No. 2). The Minister of Health approved Interim Order No. 2 on March 1, 2021, to address the unprecedented demand and urgent need for medical devices to treat, diagnose and protect Canadians against COVID-19. This guidance covers sections 14 to 18 of the interim order. It remains in effect as long as the interim order is in effect. … This guidance document includes new regulatory requirements for manufacturers, importers and distributors of COVID-19-related devices under Interim Order No. 2. The guidance is intended to help manufacturers, importers and distributors meet their regulatory obligations. It outlines their responsibilities concerning the mandatory reporting of medical device shortages"--Background, page 4. Medical instruments and apparatus industry Government policy Canada. COVID-19 (Disease) Government policy Canada. COVID-19 Pandemic, 2020-2023 Canada. Canada. Health Canada, issuing body. Lignes directrices sur la déclaration des pénuries d'instruments médicaux dans le cadre de la pandémie de COVID 19. (CaOODSP)9.897562 COVID-19 guidance for reporting medical device shortages (GUI-0137). (CaOODSP)9.892009 PDF 915 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H14-353-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drug-medical-device-food-shortages/guidance-reporting-shortages.html