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Exporting to Canada — Requirements for Foreign Manufacturers

Overview​

Foreign manufacturers exporting medical devices to Canada must meet the same requirements as Canadian manufacturers with respect to Device Licences. Canada does not have a separate "import registration" process — the Device Licence is held by the manufacturer regardless of country of origin.

Step-by-step pathway for foreign manufacturers​

Step 1 — Classify the device​

Apply Schedule 2 of the Medical Devices Regulations to determine the device class (Class I–IV). The classification rules are the same regardless of whether the manufacturer is Canadian or foreign.

Step 2 — Class I devices​

If the device is Class I, no Device Licence is required. The Canadian importer must hold an MDEL. The manufacturer does not need any specific Health Canada registration for Class I, but must ensure the device meets Safety and Effectiveness Requirements and carries bilingual labelling.

Step 3 — Class II–IV devices — obtain a Device Licence​

The foreign manufacturer must apply for and hold the Device Licence directly in their own name. Health Canada does not require a Canadian agent to hold the Device Licence.

The application must include all elements required for a domestic application, including:

  • Bilingual labelling (English and French)
  • MDSAP audit certificate (or equivalent)
  • Safety and effectiveness evidence
  • Standards compliance attestation

Step 4 — Canadian importer holds MDEL​

The Canadian importer importing the foreign manufacturer's licensed device must hold an MDEL listing "importing" as a covered activity.

Step 5 — Post-market obligations​

Post-market obligations apply to the foreign manufacturer (Device Licence holder) in the same way as to Canadian manufacturers:

  • Mandatory problem reporting
  • Recall obligations
  • Device Licence amendment obligations
  • Annual fees

MDSAP requirement​

Foreign manufacturers are required to hold a current MDSAP audit certificate (or equivalent). This is particularly convenient for manufacturers already certified for FDA (US), TGA (Australia), PMDA (Japan), or ANVISA (Brazil) — a single MDSAP audit satisfies all five jurisdictions.

Bilingual labelling​

All devices sold in Canada — including imported devices — must carry bilingual English and French labelling. This is a common barrier for foreign manufacturers and must be addressed before the first Device Licence application. See Bilingual Requirements.

Parallel submissions​

Foreign manufacturers seeking registration in multiple jurisdictions may benefit from parallel submissions to Health Canada and other regulators (FDA, TGA, EU). Canada's requirements are broadly compatible with IMDRF standards, facilitating parallel filing.