A “medical device” covers a wide range of health and medical instruments. The Therapeutic Products Directorate (TPD) of Health Canada regulates the licensing of both facilities and devices.
All manufacturers, distributors and importers of medical devices are required to obtain a unique facility licence for their business. A Medical Device Establishment Licence (MDEL) is issued for the activities of importing and selling medical devices in Canada. Medical device products also require separate product licences apart from the MDEL. An MDEL is issued based on the proposed establishment certifying that they are compliant with the regulations. The establishment will be inspected for compliance by Health Canada prior to receiving the licence. Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.
NHP Consulting will apply for a DEL on your behalf, providing the necessary documentation and being your primary advocate with Health Canada.