In Canada, condoms as contraceptive devices are classified as medical devices, and are subject to regulatory control under the Food and Drugs Act and Medical Devices Regulations. Some requirements apply to all condoms. For example, all condoms must be packaged and labelled, and all manufacturers must notify Health Canada regarding the sale of condoms.
In addition, latex condoms must meet design, length and width requirements as well as specific tests for water leakage, bursting volume and bursting pressure. Condoms are tested and must achieve safety levels of 99.9%; otherwise, they must be withdrawn from the market and re-evaluated.