In July 1998, new Medical Device Regulations were implemented in Canada to improve the safety of medical devices sold in Canada and to bring Canada's regulations in line with those of our major trading partners, an important feature of the new regulations was the establishment of the device classes and licensing requirements. All Class II, III, and IV medical devices sold in Canada must have a valid Medical Device license issued by Health Canada before they are sold . A Manufacture must obtain a license before importing, advertising or selling any class II, III or IV device. A distributor of medical devices cannot legally sell an unlicensed device. As Health Care Facilities in Canada it is our responsibility to verify that all class II, III and IV devices have a valid license before purchasing and using them. Dialysis machines are classified as class II devices while Water treatment systems are classified as classIII.
Even though this law has been in place since July of 1998, and a Warning issued in January of 2001 in regards to this, Hospitals and Technologists are still not aware of this. We are building a new facility and we are fighting with consultants and manufactures over this.
We owe it to our patients to ensure the best quality treatment we can provide, that includes being compliant with all regulations under Canadian law.
Even though this law has been in place since July of 1998, and a Warning issued in January of 2001 in regards to this, Hospitals and Technologists are still not aware of this. We are building a new facility and we are fighting with consultants and manufactures over this.
We owe it to our patients to ensure the best quality treatment we can provide, that includes being compliant with all regulations under Canadian law.
