Canadian medical device labels must be truthful, accurate and not misleading and require specific mandatory label information as outlined in the Medical Device Regulations, some of which must be presented in both English and French.
The labelling of medical devices is governed by the Food and Drugs Act and the Medical Device Regulations and must not be false, misleading or deceptive. The Medical Device Regulations provides general labelling requirements for medical devices of any class. These general requirements include the name of the device, the name and address of the manufacturer, the device identifier, a control number for Class III or IV devices, package contents, expiry date, an indication if the product is sterile if applicable, conditions of use and performance specifications, directions of use and any special storage conditions as applicable. The required label information can be displayed on labels affixed to the device or in package inserts, brochures or leaflets provided with the device if the package is too small to display the information. All required label information is to be legible, permanent and prominent and easily understood by the intended user. Specifically, when devices are sold to the general public, all required information, with the exception of the name and address of the manufacturer, device identifier and control number, is required to be in both English and French.
NHP Consulting will review your Canadian medical device labels for compliance and provide complete French translation of your product labels.