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Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Device Regulations (MDR).
The purpose of the Medical Devices Regulations is to help protect the health and safety of Canadians with respect to the sale of medical devices. The term 'medical device' covers a variety of products. Examples include: toothbrushes, bandages, knee implants, blood glucose meters, surgical instruments, and pacemakers.
Currently all Class A medical devices must have a CMDN, and all Notified (those listed in Circular No. 2021-001-A) Class B, C and D medical devices must have a CMDR.
Links to acts and regulations, guidance documents and policies related to medical devices from Health Canada
A. Certificate of Medical Device Notification (CMDN) – refers to the authorization issued for a medical device that complies with all the requirements for Notification of a medical device. The CMDN is issued for medical devices that will fall under Class A or low risk medical devices.
Starting 1 April 2022, only class B, C and D medical devices with issued CMDN or with pending application for CMDN shall be allowed to be exported from the Philippines or manufactured, imported, distributed, transferred, sold or offered for sale in the country.
Medical Devices Regulations (SOR /98-282) Regulations are current to 2024-10-14 and last amended on 2024-01-03. Previous Versions. Enabling Act: FOOD AND DRUGS ACT.
