Medical Devices Establishment Licenses

Medical Devices Establishment Licensing is covered by Sections 44 to 51 of the Medical Devices 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 Devices Establishment licence (MDEL). A DSA Regulatory Affairs Consultant can handle the licensing applications on your behalf and a DSA Quality Consultant can handle the drafting of procedures which meet the requirements of the regulations.