Establishment Licensing & HPFBI Inspections

Establishment Licencing is covered by Sections 44 to 51 of the Medical Device Regulations.

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 licencing requirements apply to you.

Required companies must apply to receive a Medical Device Establishment licence (MDEL).

DSA can handle the licencing applications on your behalf and handle the drafting of procedures which meet the requirements of the regulations.

The Inspection Programme for Medical Devices started in 2003. Since that time, DSA has worked with our clients to ensure that they are prepared to handle an inspection. We review and/or prepare the required SOPs which will be subject to review by Health Canada and ensure that all required documentation is available to be reviewed. Because we handle so many inspections on behalf of our clients each year, we are always aware of the latest inspection trends so that we can ensure our clients are not caught off guard. We can assist you with a mock inspection to assess your readiness to pass an HPFBI audit and follow through to acting as your management representative during the audit itself.

Contact us today to find out how we can help you apply for an Establishment Licence or prepare for your upcoming inspection. For more information on services offered, click here to request a copy of our free brochure.

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