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IVD License Applications Focus of Health Canada Draft Guidance

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Manufacturers of Class III and Class IV in vitro diagnostic (IVD) devices will submit similar clinical and scientific information for summary technical document (STED)-based and non-STED-based license applications and amendments in Canada, according to two draft guidance documents. Aimed at reducing costs and review times, STED-based applications consist of one module for specific Health Canada requirements and a second module to address STED-based requirements. The STED-based component, developed by the Global Harmonization Task Force, requests descriptions for IVDs beyond that required by Health Canada, which must reference a product’s history and/or previous generation.
International Medical Device Regulatory Monitor