Healthcare, Medical Devices, Regulatory Affairs

Health Canada clears its stand on Research-Use Only COVID-19 Tests

Health Canada have released a notice on research use only Covid tests and clarified its stand. The “For Research Use Only” labeled devices shall be used only in the laboratories during the development phase or for pilot testing and cannot be used either for clinical trial or commercial testing or for sale.

The In-vitro diagnostic is not considered to be in research phase, if it has been validated for performance characteristics, or has a registration application submitted to Health Canada and is under review by Health Canada, or if the IFU claims its performance. It is the responsibility of the manufacturers, importers and distributors of research use only IVDs to ensure that the correct labeling of the kits and are used solely for the purpose of laboratory testing.

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