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What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023
Due to remote working conditions implemented at the outset of the COVID-19 pandemic, Health Canada was unable to process paper-based …
The purpose of this bulletin is two-fold: advise Medical Device Establishment Licence (MDEL) holders of the notice of intent published …
This notice is to inform licence holders that the List of Medical Devices – Notification of Shortages was updated on …
This document is intended to help ensure consistency among Health Canada inspectors during medical device establishment inspections when classifying observations …
These guidelines describe how Health Canada inspects licensed medical device establishments (companies). They describe the inspection process and explain how …
Health Canada may inspect anyone who has a medical device establishment licence (MDEL) to ensure they comply with the Act …
If you manufacture, advertise or sell medical devices, certain sections of the Food and Drugs Act (the Act) apply to …
This section explains what inspectors look for when they assess your compliance with the Medical Devices Regulations (the Regulations). It …
As stated in the Food and Drug Act, Health Canada has the authority to withhold services, approvals, rights and/or privileges, …