IVD Medical Devices

As a Manufacturer of an in-vitro diagnostic medical device, you must meet all of the requirements of the regulatory body responsible in the market where you intend to sell or import your medical device into.

In-Vitro, (Latin: in-glass) is a test or study performed on micro-organisms, tissues, or other organic matter, outside of its natural environment. In-vitro diagnostics (IVDs) are tests that analyze samples of human blood or other tissues from the body. These tests are regulated as medical devices in the United States by the Food and Drug Administration, and in Canada by Health Canada.


All IVD medical devices sold in Canada must hold a licence granted by Health Canada. The type of licence required depends on the class of medical device

Our Services

  • Medical device classification
  • Preparation of Medical Device Licence (MDL) applications
  • Preparation of Medical Device Establishment Licence (MDEL) applications
  • MDEL renewals
  • MDL & MDEL amendments
  • QMS design and development to meet Canadian requirements
  • QMS audit and assessment against ISO 13485 standards
  • SOP & PnP preparation and review

United States

All IVD medical devices sold in the United States must be registered with the US Food and Drug Administration (US FDA). The type of registration required depends on the class of the device.

Our Services

  • Medical Device Classification
  • Medical Device Establishment Registration and Listing
  • Preparation of Premarket Notification 510(k) Submissions
  • Preparation of Premarket Approval
  • Medical Device Manufacturing Compliance (CMC) Support
  • Applications for an Investigational Device Exemption (IDE)
  • Current Good Manufacturing Practices (cGMP) Audit and Review
  • Medical Device Label Review
  • Medical Device Reporting (MDR)

Contact our medical device specialists using the form below to get support with getting your IVD medical devices to market