At a Glance The U.S. Food and Drug Administration (FDA) classifies medical devices into Class I, Class II, or Class III according to the regulatory controls necessary to provide reasonable […] Read More >>
Health Canada has finalized the second phase of its modernization of the Medical Device Establishment Licence (MDEL) framework, publishing amendments to the Medical Devices Regulations in the Canada Gazette, Part […] Read More >>
The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. […] Read More >>
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