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Can authorities request the Technical File?

Yes, authorities can legally demand the Technical File to verify product safety.

While you do not need to submit the file before selling, you must provide it immediately if a regulatory agency requests an inspection.

Why Regulators Request It

  • Random Audits: Routine market surveillance checks.
  • Safety Incidents: Investigations following user injuries or complaints.
  • Border Controls: Customs inspections holding shipments at the port.

Regional Enforcement Actions

  • European Union (EU): Market surveillance authorities can demand the file under GPSR rules. You typically have 10 working days to comply. Failure results in fines, sales bans, or continent-wide recalls.
  • United States (US): The CPSC or FCC can request certificates (CPC/GCC) and underlying lab test reports. Refusal leads to seized shipments at the border and heavy civil penalties.
  • Canada: Health Canada inspectors can enter businesses to audit compliance records. Importers must produce these documents quickly or face strict stop-sale orders.
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