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Inspection Program

Overview​

Health Canada's inspection program involves on-site visits to manufacturers, importers, and distributors of medical devices. Inspections verify compliance with the Medical Devices Regulations and the QMS requirements for establishment licence holders.

Types of inspections​

Routine inspections​

Scheduled inspections of MDEL holders, typically on a risk-based cycle (e.g., every 2–5 years depending on risk level). Routine inspections are announced in advance.

Surveillance inspections​

Targeted inspections triggered by:

  • Mandatory problem reports or recall activities
  • Complaints received by Health Canada
  • Intelligence from other regulatory authorities
  • Post-market testing results

Surveillance inspections may be unannounced.

For cause inspections​

Inspections specifically investigating a suspected compliance issue. These are typically unannounced or at very short notice.

What inspectors look for​

For manufacturers, inspectors typically review:

  • QMS documentation (quality manual, procedures, records)
  • MDSAP or ISO 13485 audit certificate validity
  • Device Licence maintenance (amendments filed when required)
  • Post-market surveillance and complaint handling records
  • Mandatory problem reporting records
  • Recall procedures and records
  • Labelling compliance

For importers and distributors, inspectors typically review:

  • MDEL validity and currency
  • QMS elements (complaint handling, distribution records, recall procedures)
  • Distribution records (lot-level traceability)
  • Mandatory problem reporting records
  • Evidence that all distributed devices hold valid Device Licences

Preparing for an inspection​

Best practices for inspection readiness: • Maintain your Quality Management System in a continuously inspection-ready state • Conduct periodic internal audits (at least annually) to identify gaps before Health Canada inspections • Ensure all QMS documentation is current, accessible, and accurately indexed • Provide regular training to all relevant staff on their QMS roles and responsibilities • Keep records of training completion and document all corrective actions taken • Maintain a log of any changes made to the device, manufacturing process, or QMS since the last inspection

Inspection outcomes​

After an inspection, Health Canada issues an inspection report classifying the findings:

  • Satisfactory — no significant deficiencies
  • Acceptable with deficiencies — minor deficiencies identified, corrective actions required
  • Non-compliant — significant deficiencies; corrective action plan required with follow-up inspection possible
  • Unsatisfactory — serious non-compliance; may trigger immediate enforcement action

Legislative source: Food and Drugs Act, ss 22–23; Medical Devices Regulations, SOR/98-282

Health Canada typically establishes inspection cycles based on device risk classification and compliance history. Class III and IV devices generally receive more frequent inspections than Class I and II devices.