加拿大進出口健康產品要求 – 加拿大衛生部規定

Yes. Even when products are exported from Canada and not sold domestically, certain regulatory obligations may still apply depending on the product category and activities performed. Companies involved in importing, packaging, labeling, or distributing health products may still require appropriate licences and must comply with applicable Health Canada regulations, including record-keeping and traceability.

如果設備僅用於展示或評估而非商業銷售，某些情況下可以透過研究或測試用途安排進入加拿大市場。然而，如果產品被宣稱具有醫療用途並實際提供給使用者，則通常仍需要相應的醫療器械許可。建議在寄送樣品前確認 Health Canada 的相關指引，以避免被視為未授權銷售。

If your company is importing or distributing medical devices in Canada, you typically need a Medical Device Establishment Licence (MDEL), even if the device already has a Medical Device Licence (MDL). The MDL applies to the device itself (for Class II–IV devices), while the MDEL applies to the company performing activities such as importing or distributing. Importers must also maintain distribution records and complaint handling procedures to comply with Health Canada requirements.

CE 標誌本身不能直接替代加拿大的醫療器械許可。若軟體被分類為 Class II–IV 醫療器械，仍需要向 Health Canada 申請 Medical Device Licence（MDL）。不過，若企業已具備 ISO 13485 或其他國際品質體系證書，可能有助於加快準備申請資料。

如果公司在加拿大境内进行进口、储存或分销医疗器械，即使最终目的地是其他国家，通常仍需要符合 Health Canada 的建立许可（MDEL）要求。监管重点在于公司在加拿大境内进行的活动，而不仅仅是产品最终销售地点。

如果產品僅標示為 Research Use Only（RUO）並且不會用於臨床診斷，通常不需要醫療器械上市許可。但進口商或分銷商仍可能需要符合 Health Canada 的建立許可（MDEL）要求。此外，產品標籤與宣傳資料必須明確標示其研究用途，避免被視為醫療用途。建議在出口前確認加拿大進口商的合規義務。