Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is in accordance with proposed amendments under section 36 of the Medical Devices Regulations (MDR). These proposed regulations will allow Health Canada to expand the scope of use of T&Cs and impose and amend T&Cs at any time during the medical device’s life cycle.

Scope and Application

This guidance document applies to T&Cs imposed on Class II to IV medical device licences under subsection 36(2) of the MDR.

This 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.

Policy Objectives

The objective of this change is to ensure that T&Cs are imposed and amended fairly and consistently and that regulated parties are given an opportunity to voice their concerns or submit suggested modifications to the T&Cs before they are imposed.

The purpose of T&Cs is explained in the document, outlining the process that will be applied when T&Cs are imposed on Class II to IV medical device licences or when they are amended (which includes the removal of T&Cs).

Policy Statements

The proposed regulations will give the Minister power to impose and amend T&Cs on Class II to IV medical device licences at any time during the device’s life cycle. This will encourage medical device manufacturers to take steps to address the safety, effectiveness, risks, and benefits of their products.

Health Canada’s ability to oversee and asses devices will be enhanced under this proposal. This will allow Health Canada to identify issues sooner and address them faster through the oversight provided by T&Cs.

It is important to note that Health Canada is not changing the issuance requirements for medical device licences.

At the moment, the Minister may impose T&Cs on a medical device licence requiring that manufacturers:

• conduct tests on a device to ensure it continues to meet the safety and effectiveness requirements of sections 10 to 20 of the MDR.
• submit the results and protocols of any tests performed.

The Minister may also amend T&Cs imposed on a medical device licence to capture any new developments with that device.

With the proposed amendments T&Cs may be imposed on Class II to IV medical device licences at the time of licensing or any time after. T&Cs may also be amended at any time.

The goal of imposing or amending T&Cs is to meet 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.

The Minister will 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 there are other legislative tools that 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

About Terms and Conditions

Medical device licences may be issued with or without T&Cs. These T&Cs may be imposed or amended at any time post-market. Each T&C may also have a different timeline in which it must be fulfilled and there is no limit on the number of T&Cs or amendments that may be imposed on a licence.

Here are a few examples of circumstances that may require a T&C to be imposed or amended:

• uncertainties exist at the time of licensing that could impact safety and effectiveness, but cannot really be resolved during pre-market review.
  • such as the long-term clinical performance of the device.
• new information about the device’s performance in the real world suggests uncertainties with its safety or effectiveness.

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 licence decision.
• final results to confirm interim results, most often related to clinical evidence, stability studies, or aging testing.

These examples may be applied upon licensing, after licensing, or both.

Amending Terms and Conditions

Amending a T&C involved either modifying or removing a 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 at a later point in time, 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.

Both Health Canada and the manufacturer may request an amendment to a T&C, although in general Health Canada will initiate the amendments. Should a manufacturer wish to have a T&C amended, they have to provide Health Canada with the following for the Minister’s consideration:

• a strong rationale as to why they are requesting an amendment.
  • for example, a study cannot be completed for scientific or technical reasons.
• a detailed description of the proposed amendment.

Communicating with Manufacturers

When imposing a new T&C or amending an existing one on a medical device, Health Canda will inform the manufacturer in writing with the following, as applicable:

• 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 time period for making representations on the proposed T&C.
• potential consequences of non-compliance with a T&C.

The manufacturer will have up to 10 calendar days to submit a response before the T&C comes into effect. Manufacturers may voice their concerns or submit modifications to the proposed T&C during this 10-day period. The Minister will consider any submission and issue a decision along with a rationale with the final T&Cs.

Enforcing Terms and Conditions

Section 21.7 of the Food and Drugs Act (FDA) requires medical device licence 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:

• licence suspension (section 40 of the MDR) or;
• prosecution of the medical device licence holder (section 31.2 and, in some cases, section 31.4 of the FDA).

A licence holder may be liable to fines or imprisonment.

Transparency

Health Canada will begin to publish all information about all T&Cs imported on medical device licences, including new and amended T&Cs. This will be done to increase transparency and communicate risks to people in Canada. These summaries will look to be published regularly and will not include the following

• 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.

This article provides a supplemental review of Health Canada’s draft guidance document, “Draft guidance document: Terms and conditions for medical devices“, and is not a substitute for reading the full draft guidance.

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