Medical Device Establishment Licenses

Medical Device Establishment Licensing is covered by Sections 44 to 51 of the Medical Device Regulations as found in the Food & Drug Regulations (FDR). With some exceptions, most companies who import or sell devices for human use (other than for personal use) will require a license.

DSA can help you determine if licensing requirements apply to you. Required companies must apply to receive a Medical Device Establishment licence (MDEL). A DSA Medical Device Regulatory Affairs Consultant can handle the licensing applications on your behalf and handle the drafting of procedures which meet the requirements of the regulations.

A DSA Regulatory Affairs Consultant will work with you to determine which licensing requirements apply to your firm. Activities and product lists are reviewed to determine the impact of the medical device regulations on your firm.

If medical device licenses are required for your products, a DSA Regulatory Affairs Consultant will work with you to determine product registration requirements. If your firm does not have the required procedures to address the MDEL attestations, a DSA Quality Consultant will work with you to draft procedures which meet Health Canada requirements.

To find out more about marketing a therapeutic product in Canada, please click here to receive a copy of our free white paper. To find out more about using our Regulatory Affairs Services for Medical Devices, please contact us for more information.