Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety. The third IO replaced the second IO on February 21, 2022. The first IO was replaced by the second IO on March 1, 2021. The Minister of Health approved the first Interim Order (IO) for the importation and sale of COVID-19 medical devices on March 18, 2020, which is one of the fastest mechanisms available to address large-scale public health emergencies. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19. The guidance outlines recommendations regarding the minimum testing that should be performed for SARS-CoV-2 diagnostics to support an application for an authorization under Interim Order No. The purpose of this document is to provide guidance to manufacturers of serological assays intended for the detection of antibodies to SARS-CoV-2, the virus that causes COVID-19 disease. Annex 1 - Recommended Format for Summary of Validation Studies.Class specificity (for antibody tests only).List of optional organisms to be tested for cross-reactivity (may be a post-market condition).List of mandatory organisms to be tested for cross-reactivity.Manufacturing, ramping up capacity and estimates of distribution to Canada.Quality, safety and effectiveness information.Note: As research evolves and we learn more about the virus, the disease and the immune response, the requirements in this Guidance may be updated based on the latest scientific evidence 2 that appear in this guidance as references to the equivalent provisions in Part 1.1 of the Medical Devices Regulations.
This guidance remains in effect, however, stakeholders should read references to the numbered provisions of Interim Order No. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.
Health Canada will be updating the content of this page soon. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No.
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