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 MDEL (Medical Device Establishment 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.  Issuance of an MDEL will lead to an onsite inspection from Health Canada of the licensed party.  DSA can help you prepare for this inspection and host the inspection on your behalf.