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Health Canada Issues New Plan for Medical Devices
On Thursday December 27th, Health Canada detailed a new three-part method aimed to help safety, oversight and quality in the Canadian medical device market. This plan has come soon after the investigation of the...
FDA Proposes Major Changes to De Novo Pathway
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this...
FDA to Overhaul 510(k) Device Approval Process
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially...