Policy on terms and conditions for medical device establishment licences (POL-0156)
Date issued: July 26, 2024
Date implemented: December 14, 2024
Disclaimer: This administrative document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document will help regulated parties comply with the legislation and other applicable policies.
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Introduction
The Food and Drugs Act and the Medical Devices Regulations establish the framework to ensure the safety, quality and effectiveness of medical devices available to people in Canada. Medical device establishment licences (MDELs), which make it possible to conduct licensable activities, are part of this framework.
Purpose
This document describes Health Canada's guiding principles on the use of terms and conditions on MDELs.
Scope
This policy applies to terms and conditions on MDELs, as per section 48.1 of the regulations. Such terms and conditions give Health Canada greater flexibility in addressing and managing non-compliance. They also help to support the health and safety needs of people in Canada. We may impose or amend terms and conditions at any time, including when the MDEL is first issued.
The policy
Imposing terms and conditions
Health Canada considers 4 factors when imposing terms and conditions:
- managing risks
- considering the act
- determining feasibility
- reducing burden
1. Managing risks
An MDEL holder may sometimes conduct activities that do not fully comply with the act or the regulations. When we become aware of health risks associated with these activities, we take the necessary regulatory action such as imposing terms and conditions. Terms and conditions make it possible for us to increase our ability to monitor or restrict specific activities.
Terms and conditions are in effect until the MDEL holder is able to give evidence that the specific risks have been resolved.
Terms and conditions may be imposed to address:
- health risks without impacting the availability of critical medical devices in Canada and allow people in Canada to have continued access to safe and effective medical devices
- identified potential risks after inspecting an MDEL establishment that supplies critical medical devices to people in Canada
- identified potential safety and effectiveness issue saffecting vulnerable populations
- identified deficiencies after inspecting an MDEL holder that has exclusive distribution rights of the device in Canada and has implemented corrective and preventive actions
- uncertainties in medical devices or MDEL activities by gathering information
2. Considering the act
Before we impose terms and conditions, we determine if:
- the requirements and authorities set out in the act are sufficient to address the health risks
- other compliance and enforcement activities are more suitable to manage the risks posed to human health and safety
We choose the actions and tools that are most appropriate for the situation, based on a number of factors.
Learn more:
3. Determining feasibility
We ensure that the requirements and timelines set out in proposed terms and conditions are realistic, feasible and suitable for addressing the associated risk.
4. Reducing burden
When it comes to health risks, we:
- consider if there are better ways to mitigate those risks and reduce the burden for the MDEL holder
- may use more than 1 compliance and enforcement measure, including terms and conditions, to manage those risks
Timing of terms and conditions
Terms and conditions may be added or amended at any time while an MDEL is active. In general, the timing is based on when we have reasonable grounds to believe that terms and conditions are the best way to mitigate health risks.
Opportunity to be heard
Before we issue new or amend existing terms and conditions, we give the MDEL holder an opportunity to be heard.
MDEL holders have up to 15 business days to submit a written response to the proposed terms and conditions. They may outline their concerns or submit their suggestions for modifying the proposed terms and conditions.
Our written notification to the MDEL holder includes the:
- amended or proposed terms and conditions
- issue that these terms and conditions address
- requirements and associated timelines
- deadline for submitting a response
If we do not receive a response by the deadline, we will proceed with the terms and conditions we proposed.
Failure to comply
We may take other compliance and enforcement actions if we have reasonable grounds to believe that an MDEL holder is not complying with the terms and conditions imposed on their MDEL.
Learn more:
Amending and removing terms and conditions
Terms and conditions provide flexibility in how risks and non-compliance are managed. We may amend or remove them if relevant new information is received that has an impact.
If we first become aware of this new information, we will contact the MDEL holder for clarification or validation. If the terms and conditions have to be amended or removed, we will communicate any proposed changes to the MDEL holder and give a timeframe for doing so.
MDEL holders who have made progress or resolved the issues for which terms and conditions were imposed may ask Health Canada to consider amending or removing the terms and conditions.
Use the following form to submit the request in writing:
Transparency
Information about compliance and enforcement activities will be made public. This includes the results of any decisions concerning terms and conditions applied to MDEL holders.
Making this type of information public helps people in Canada make informed choices when purchasing and using medical devices.
Learn more on when and where terms and conditions will be published by visiting this webpage regularly:
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