The US Food and Drug Administration has published a highly anticipated proposed rule to harmonise its medical device quality management...

The first Interim Order issued by Health Canada (HC) to govern the importation and sale of medical devices needed to diagnose or treat...

Canadian medical device market regulator Health Canada has published a new round of updates regarding its Medical Devices Action Plan...

In order to market health products in Canada, manufacturers, private labelers, importers and distributors must be in compliance with the...