Health Canada’s proposed updates to the MDEL guidance documents

by | Mar 25, 2024 | Canadian Quality Assurance, Canadian Regulatory, Medical Devices

The proposed amendments to the Medical Device Regulations (MDR) would allow Health Canada to impose Terms and Conditions (T&Cs) on Medical Device Establishment Licences (MDEL) at anytime during the licence lifecycle. This policy is drafted in order to provide Health Canada with additional oversight and to address potential risks related to medical devices or licensed activities.  

Should Health Canada discover high risks or non-compliance activities concerning medical devices, it reserves the right to impose T&Cs on specific areas of non-compliance among MDEL holders. This may involve actions like suspending or limiting non-compliance while permitting compliant activities to proceed, ensuring continued access to medical devices for Canadians.  

Updates to the MDEL application form (FRM-0292): A new sub section requiring the applicant to enter any other establishment name(s) including the start and end date under which licensable activities were conducted in the past, is proposed to be added.  

Updates to the Medical Device Recall Guide (GUI-0054): An update to the regulatory definition of “recall” has been proposed to include ordered recalls initiated by the Minister. With this, a retention time for recall record keeping is also under review. The detailed proposal also outlines the communication requirements with Health Canada while working on a recall. Kindly note that per the new requirements, an applicant won’t be permitted to sell the modified device and implement the correction on the devices affected by the recall on the market unless an amended Medical Device Licence is issued.  

Reach out to find out more about how these proposed updates may impact your business.