Health Canada has declared batteries that power medical devices, such as hearing aids, also as medical devices. If the batteries are sold to power Class I medical devices, they are also considered to be Class I medical devices. If the batteries are sold to power Class II, III, or IV medical devices, then they are classified as Class II medical devices. These medical batteries are regulated under the Food and Drugs Act and the Medical Devices Regulations. Manufacturers of the Class I medical batteries may need to have a Medical Device Establishment Licence (MDEL) where manufacturers of Class II medical batteries must have a Medical Device Licence (MDL). Along with this, importers and distributors of medical batteries will have to have a MDEL. Also, one cannot import or sell Class II medical devices unless the manufacturer has a MDL.
In addition, multipurpose batteries that are sold for the purpose of powering both medical and non-medical devices are not considered to be medical devices.
We hope that this information is helpful to you. If you have any questions, please feel free to contact Focal Point Research. We are industry leading Medical Device Consultants that you can trust to help guide your company in the right direction.