Health Canada Updates: 4 Proposed Changes in Phase II of MDEL
Canada has classified medical devices into four classes based on risk level associated with the device. Although Class I medical devices are lowest risk devices, companies are still required to abide by certain regulatory obligations. To operate legally in Canada,...
What are the Differences Between Health Canada MDL and MDEL?
Health Canada issues two types of licenses, medical device establishment licence (MDEL) and medical device licence (MDL). Medical devices are categorised into Class I, II, III, and IV, based on risk level. It is important to determine the class to which your medical...