Immediate suspensions of Medical Device Establishment Licences (MDELs)
MDEL Bulletin December 15, 2020 from the Medical Devices Compliance Program
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About COVID-19 devices
The demand for medical devices during the COVID-19 pandemic is unprecedented. To help meet the demand, in March 2020, Health Canada began expediting the issuance of Medical Device Establishment Licences (MDELs) to facilitate the importation and sale of class I-IV COVID-devices and the manufacturing of class I COVID-devices.
The devices range from:
- Class I devices, such as masks, respirators, face shields, gowns and swabs
- Class II devices, such as gloves, infrared and digital thermometers, and oxygen concentrators
- Class III devices, such as ventilators and continuous monitoring pulse oximeters
- Class IV devices, such as diagnostic devices and kits
They're needed to help:
- protect against the transmission of COVID-19 in health care settings
- detect the virus as part of public health measures
- treat symptoms of COVID-19 in hospitals and intensive care units
Our priority as a department is to ensure these critical COVID-19 devices are safe and effective and that device problems in the supply chain can be addressed rapidly.
Your role as an MDEL holder
As an MDEL holder, you're obligated as part of your licence to document and maintain procedures and records on distribution, complaint handling and recalls.
Distribution records are key to an establishment's ability to track the distribution of devices. Recall procedures are important when risks are identified and customers need to be contacted. Complaint handing procedures are used to ensure that feedback from customers is shared with the manufacturer (where required) and reviewed.
These processes are critical to identifying quality and safety issues and managing the associated risks.
In April 2020, Health Canada began conducting remote assessments (by email and phone) of MDEL holders for COVID-devices to verify compliance with the Medical Devices Regulations. Remote assessments proactively assess compliance with the 3 requirements that are critical to ensuring a responsive, safe and secure supply chain:
- distribution records
- recall and complaint handling procedures
- responsiveness to our requests (3 consecutive non-responses are considered high-risk)
If a Health Canada inspector contacts you, you are required to acknowledge and respond to their requests. This demonstrates your ability to respond to urgent requests where the health and safety of Canadians is at risk.
During remote assessments, you are asked for copies of the procedures and documents that have been attested to in the MDEL application. You are also asked for a list of devices that your establishment is manufacturing, importing and/or distributing.
Suspensions of MDELs
Establishments that do not respond or provide the requested documents will have their MDEL immediately suspended. This is in accordance with section 50(1) of the Regulations:
- The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health or safety of patients, users or other persons, by giving the licensee a notice in writing that states the reason for the suspension.
The suspension takes effect immediately. It prohibits the establishment from conducting any licensable activities. Non-compliance with the suspension will result in escalated enforcement actions under the Food and Drugs Act.
Under subsections 50(2) and (3) of the Regulations, an MDEL holder may ask for the suspension to be reconsidered. Health Canada will reinstate the licence only if the situation that gave rise to the suspension is corrected or the reason for the suspension was unfounded.
All COVID-19-associated MDEL suspensions are posted on our website.
For any questions about MDEL suspensions, please email us at hc.mdel.suspension.leim.sc@canada.ca
For all other questions related to MDELs, please email us at hc.mdel.questions.leim.sc@canada.ca.