Introduction:
It was recently announced that Health Canada will be expanding the Terms and Conditions (T&Cs) of Class II-IV medical device licenses to further support the life cycle approach for regulating medical devices.
This is related to recent amendments under section 36 of the Medical Device Regulations (MDR). Health Canada plans to use these regulations to expand medical device usage which could be amended during the life cycle of medical devices.
In this blog, we’ll provide a high-level overview of Health Canada’s T&C Medical Device draft guidance.
What is the scope & application of the recent MDR Draft Guidance? Policy Objectives:
The guidance document applies to T&Cs imposed on Class II to IV medical device licenses under subsection 36(2) of the MDR. The term “medical device,” as used in this document, is defined in the MDR as follows:
- medical device means a device within the meaning of the Act [FDA] but does not include any device that is intended for use about animals (section 1)
The guidance document does not address the following T & Cs:
- those imposed on a “lot of in vitro diagnostic devices” (section 37 of the MDR) or;
- those imposed on medical devices authorized under interim orders for the importation and sale of medical devices for use in relation to COVID-19.
This change is to ensure that T&Cs are imposed and managed in a fair manner that is consistent, giving all regulated parties a chance to express their worries or submit potential modifications to the T&C.
Health Canada MDR Policy Statements:
The Minister, under these proposed regulations, will now have the power to amend T&Cs during the medical devices’ life cycle. The hope is that this will encourage medical device manufacturers to take proactive steps to address their risks, benefits, and safety. At this time Health Canada will NOT be changing the issuance requirements for medical device licenses but may require manufacturers too;
- submit the results and protocols of any tests performed.
- conduct tests on a device to ensure it continues to meet the safety and effectiveness requirements of sections 10 to 20 of the MDR.
The ultimate goal of imposing or amending T&Cs is the following objectives:
- maintain the safety and effectiveness of the medical device:
- by ensuring the device continues to meet applicable safety and effectiveness requirements of sections 10 to 20 of the MDR.
- optimize the benefits and manage the risks associated with the medical device.
- identify changes and manage uncertainties related to the benefits and risks of the medical device.
Health Canada’s Minister would consider the following before imposing or amending a T&C:
- there are uncertainties relating to the benefits or risks associated with the medical device.
- the requirements under the FDA are sufficient to meet the stated objectives.
- By considering, for example, if other legislative tools can be used to meet the objectives instead of using T&Cs.
- the proposed T&C may contribute to meeting the objectives.
- For example, by not knowingly requesting T&Cs that would not fulfill the stated objectives.
- compliance with the proposed T&Cs is technically feasible.
- there are less burdensome ways to meet the objectives of the proposed T&Cs
Do you need Health Canada Medical Device Regulatory Assistance!
What should I know about the draft guidance terms & conditions?
Medical device licenses might still be issued without T&Cs and may be amended at any time. Each one may also have a different timeline for the fulfillment, or a different number of T&Cs imposed on the license before, during, or post-licensing.
Here are some examples of what medical device manufacturers may be required to provide through T&Cs:
- stability study results.
- real-time aging results.
- new evidence from post-market studies.
- performance data to confirm acceptable variations over time.
- clinical data collected from underrepresented patient populations:
- to assess impacts based on sex or gender, for example.
- future international market experience;
- sales and incident data in Canada or internationally are to be submitted annually to verify that the safety profile of the device remains acceptable and similar to what it was at the time of licensing, for example.
- clinical study results, for example:
- long-term, ongoing follow-ups of clinical studies.
- final results of device-specific clinical studies in cases where strong interim data were used to support a medical device license decision.
- final results to confirm interim results, most often related to clinical evidence, stability studies, or aging testing.
Will Health Canada ever remove or modify a T&C?
Both Health Canada and the medical device manufacturer can request amendments for any T&C. Here are a few examples of when Health Canada may modify a T&C:
- further clarification is required to resolve uncertainty.
- when the requested evidence has been provided but fails to completely address or resolve the uncertainty that was identified, for example.
- the required data are not yet available and will be provided later, necessitating a new T&C deadline.
- new information about the device is provided by a third party, identified in the published literature, or collected by Health Canada.
- the information provided resolves the issue, resulting in the T&C being fulfilled and subsequently removed.
How will Health Canada communicate T&C changes?
When Health Canada imposes or amends new T&Cs, they’ll notify the manufacturer in writing with;
- the issue that has been identified.
- the proposed T&C, its objective, and the timeframe for fulfilling the T&C.
- the legal authority that supports the imposition of the proposed T&C.
- the submission requirements to fulfill the proposed T&C, instructions on what to include in the response, and how to submit the response.
- the period for making representations on the proposed T&C.
- potential consequences of non-compliance with a T&C.
Following the notification, the manufacturer will have 10 calendar days to submit a response before the change comes into effect. This gives the manufacturers enough time to voice their concerns or submit modifications before the proposed T&C takes effect. The minister does consider each submission and includes a rationale once the T&C is finalized.
Enforcing Terms and Conditions with T&Cs which can lead to fines or imprisonment:
Section 21.7 of the Food and Drugs Act (FDA) requires medical device license holders to comply with T&Cs with all T&Cs being enforceable under the MDR and the FDA. Health Canada may consider pursuing compliance and enforcement measures against manufacturers that fail to comply. Non-compliance with T&Cs can lead to:
- license suspension (section 40 of the MDR) or;
- prosecution of the medical device license holder (section 31.2 and, in some cases, section 31.4 of the FDA).
How will Health Canada publish T&C Information?
Health Canada will publish all information about all T&Cs imported on medical device licenses, both new and amended ones. This is being done to increase transparency and improve communication. The summaries that will be regularly published through Health Canada however will not include:
- confidential business information.
- other information protected by law, such as:
- personal information as defined in the Privacy Act.
- information that is protected by the Canadian Charter of Rights and Freedoms, Section 8.
How Quality Smart Solutions can help
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Learn more about MDEL Registration, License Class Determination, In Vitro Diagnostic Devices (IVD) Registration, SaMD Classification and Registration, or our MDEL Import Agent service.
Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here:
