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Export-Only Devices

Overview​

Devices manufactured in Canada solely for export — and not intended for sale in Canada — may be exempt from some of the standard requirements that apply to devices sold domestically.

Exemptions available​

Under the Food and Drugs Act, devices intended solely for export may be exempt from certain provisions of the Medical Devices Regulations, including:

  • Device Licence requirements (if not for sale in Canada)
  • Some labelling requirements (the importing country's requirements apply instead)

Certificate of Free Sale​

To assist Canadian manufacturers in entering foreign markets, Health Canada can issue a Certificate of Free Sale (CFS) (also called a Certificate to Foreign Government). This certificate confirms that a device:

  • Is manufactured in Canada
  • Is authorised for sale in Canada (if it holds a Device Licence)
  • Is manufactured in accordance with Canadian law

Many importing countries require a CFS as part of their import registration process.

Quality system requirements still apply​

Even for export-only devices, Canadian manufacturers must maintain a quality management system that complies with the MDR. Export-only status does not exempt manufacturers from QMS requirements or MDSAP certification.

MDEL for export-only​

Canadian manufacturers producing export-only Class I devices should consult Health Canada about their specific MDEL obligations, as the activity of manufacturing for export may require MDEL registration.

Legislative source: Food and Drugs Act, s 37 (export exemptions); Medical Devices Regulations, SOR/98-282