Health Canada, the country’s regulating authority in the sphere of medical devices, has published detailed guidance dedicated to all the aspects related to the medical device establishment license (MDEL).
Apart from the regulatory procedures to be followed by an interested party in order to obtain a MDEL, the document also describes various notifications to be submitted and the steps to be taken by the license holder if its license has been suspended or canceled by the regulating authority.
Table of Contents
Submitting an Annual License Review Application
According to the applicable legislation, any and all holders of the medical device establishment licenses are required to submit an application for annual license review (ALR). Such an application should be submitted on an annual basis before April 1. Health Canada states that the purpose of the ARL is to ensure continued compliance with regulatory requirements and to maintain up-to-date information. If there were no changes made to the current license during the previous year, the license holder shall duly submit an ARL application and pay the applicable fee.
In order to assist MDEL holders in complying with the ARL submission requirements, Health Canada provides a flowchart describing the applicable reporting timelines.
- December – Health Canada emails ARL application package to all active MDEL holders;
- January – February – Recommended submission period of ARL application from MDEL holders to Health Canada;
- April 1 – The ARL application is due to Health Canada before this date;
- April – July – Processing of ARL applications completed by Health Canada.
Thus, at the end of each calendar year, the regulating authority will send application packages to any and all current holders of medical device establishment licenses. Upon this, the license holder itself shall be solely responsible for submitting a properly completed application in time. The authority also states that if a license holder has not received a package within the timeframes described above, it shall ask for further clarifications.
Health Canada additionally emphasizes that if the license holder fails to submit an ARL application within the aforementioned timeframe, the license will be canceled. Hence, the entity will be prohibited from performing any kind of activity subject to licensing thereafter. Should the entity decide to continue its operations, it would have to submit an entirely new application for a medical device establishment license and commence the process from the very beginning.
The fee associated with the ARL application should be paid within 30 calendar days from the date the appropriate invoice has been issued. The regulating authority will review the application within 120 calendar days from the date it was received. The license holder will receive two confirmation emails: the first one stating that the application has been duly received and the second one stating that the review of the application has been completed successfully. If there have been any changes made to the medical device establishment license, the holder will also receive an updated license certificate.
Updating or Cancelling MDEL
The document also describes how a medical device establishment license could be updated or canceled. According to the applicable legislation, the MDEL holder shall duly notify the regulating authority in case of changes to:
- The name or address of the establishment, or
- The information of the establishment representative associated with the MDEL application (including name, title, and telephone number).
In order to do this, the license holder shall submit a revised form FRM-0292 via the appropriate email. It is important to mention that the authority does not charge any fees for changes, notifications, or amendments to existing medical device establishment license.
An amendment to the existing MDEL will be required in the event of any changes to the information contained therein. For instance, this procedure should be applied if changes have been made to the list of manufacturers, the activity carried out by the establishment, or the class of the device.
Should the license holder decide to cancel the license, it shall cease all licensed activities and notify the regulating authority accordingly. According to the present Health Canada guidance, such a request could be submitted only by a designated contact person or a senior official of the establishment.
Actions to be Taken in Case of MDEL Suspension
The guidance additionally provides certain recommendations to be considered by the medical device establishment license holders if the regulating authority has suspended the license. According to the Medical Devices Regulations, Health Canada is entitled to suspend or cancel MDEL. In such a case, the entity should immediately stop the operations it conducts with medical devices. Otherwise, the authority will have a right to take regulatory actions.
Suspension of a license could also be considered as a regulatory action taken by the authority if the license holders fail to respond to the requests in time. According to the guidance, Health Canada is entitled to suspend a license if it has reasonable beliefs that:
- The license holder conducted a violation of the applicable legislation,
- The license holder has provided false information in the course of the initial application process,
- Continuance of the activity will expose patients and other persons to additional risks.
Before suspending the license, the authority will take into consideration the compliance history of the license holder, as well as the actual or potential risks associated thereto.
As the first step, the authority will provide the license holder with the appropriate notice indicating:
- The reason(s) for the suspension,
- Action(s)/corrective measures the license holder failed to take within a prescribed timeline following an inspection,
- The opportunity to be heard (OBTH) process.
However, should the activity of the license holder expose the patients to additional risks for the safety of patients, the authority is entitled to suspend the license without providing an opportunity to be heard. In such a case, the authority will simply inform about the way to be heard in case the establishment does not agree with the suspension. It is also important to mention that the authority is entitled to conduct an additional inspection in order to ensure the activities subject to licensing are no longer conducted.
If the former license holder intends to continue its activity, it can submit a reinstatement application. For this purpose, the establishment shall correct all the problems creating grounds for the suspension, submit the appropriate application, and also pay the fees as requested. The regulating authority will verify that the grounds for the suspension no longer exist and assess the application submitted in order to ensure it complies with the applicable regulations.
According to the current legislation, the license should be canceled in the following cases:
- The license has been suspended for more than a year,
- The license holder failed to submit an ARL application in time.
In summary, the document describes specific aspects related to reporting obligations, as well as suspension and cancellation of a medical device establishment license. The document provides additional clarifications regarding the regulatory procedures and outlines the steps to be taken by the license holder.
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