If any organization is interested in selling medical devices in Canada, you must first register and obtain the proper license from Health Canada. Your device classification will determine the license type you need to apply for. Health Canada has a four-tier, risk-based classification system (Class I, II, III, and IV).
Our Health Canada Registration Service includes:
✪ Identifying the classification of your medical device under the Health Canada system
✪ Compiling your MDL or MDEL application and submitting it to Health Canada
✪ Adapting your existing ISO 13485 quality system to meet CMDR requirements
✪ Conducting customized on-site training for ISO 13485 and CMDR compliance
✪ Renewal of existing license