MDEL Attestation Procedures

When applying for or renewing a Medical Devices Establishment License, a Senior Official of the Company is required to make attestations regarding the availability of the required procedures.

What many Senior Officials do not realize is that by signing the attestations, they are also attesting to the adequacy of the procedures. If during a Health Canada Inspection, a Medical Devices Inspector finds that a procedure does not meet regulatory requirements, the Inspector will cite the firm for the false attestation made by the Senior Official.  Senior Officials are responsible for the attestations they make to Health Canada and Health Canada publishes the name of the MDEL Senior Official as part of the MDEL listing.  This is because Health Canada wants direct visible accountability if regulatory or compliance failures occur.  It is important that Senior Officials understand this responsibility when they sign an MDEL attestation.