COVID-19 guidance for reporting medical device shortages. : H14-353/2021E-PDF

"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.

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