Guidance on terms and conditions for class II to IV medical devices

On this page

• Purpose
• Introduction
• Scope and application
• Policy objectives and statements
• Note about guidance documents in general
• About terms and conditions
• Imposing and amending terms and conditions
• Reviewing information submitted in fulfillment of terms and conditions
• Transparency
• Compliance and enforcement of terms and conditions

Purpose

This guidance document gives an overview of the regulatory authorities for terms and conditions (T&Cs) imposed or amended on medical device licences. It also provides direction and guidance to medical device licence holders and Health Canada staff on the use of T&Cs in accordance with section 36 of the Medical Devices Regulations (MDR).

Introduction

The Food and Drugs Act (FDA) and its regulations give Health Canada the authority to regulate food, drugs (including natural health products), medical devices and cosmetics. Our role as a regulator is to verify that regulatory requirements for the safety and effectiveness of medical devices are met. We do this through a combination of pre-market scrutiny, post-market surveillance and compliance and enforcement activities.

The MDR uses a risk-based approach to regulating medical devices. The safety and effectiveness evidence required by these regulations to support a licence application is in proportion to the risk presented by the device.

This approach balances 2 needs:

• the need to provide people in Canada with timely access to new and innovative technology
• the need for appropriate levels of pre-market oversight of safety and effectiveness evidence

Since 1998, under section 36 of the MDR, Health Canada may impose T&Cs on a Class II to IV medical device licence. T&Cs are used as regulatory tools to help ensure that medical devices in Canada continue to meet the safety and effectiveness requirements outlined in sections 10 to 20 of the MDR.

The Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which received Royal Assent in November 2014. Vanessa's Law introduced amendments to the FDA to:

• improve Health Canada's ability to collect post-market safety information and take appropriate action when a serious risk to health is identified and
• better protect people's health and safety and increase their confidence in therapeutic products that are available on the market

Vanessa's Law also gave the Governor in Council the authority to make regulations for therapeutic products, which includes medical devices, that support us in implementing a lifecycle approach to regulating drugs and medical devices.

Health Canada has expanded the authorities of T&Cs under subsection 36(2) of the MDR to help manage uncertainties and risks in medical devices, especially given the continued rapid pace of product innovation.

The regulations:

• expand the scope of use of T&Cs and
• enable the Minister to impose or amend T&Cs at any point during a medical device's lifecycle

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. It explains the purpose of T&Cs and outlines the process that will be applied when T&Cs are imposed or amended (includes removing T&Cs) on Class II to IV medical device licences.

This guidance explains how:

• T&Cs are imposed and amended and
• regulated parties are given an opportunity to be heard

The MDR defines "medical device" as a device within the meaning of the act, but does not include any device that is intended for use in relation to animals (section 1).

This guidance document doesn't 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 Part 1.1 of the MDR for Medical Devices for an Urgent Public Health Need

Policy objectives and statements

T&Cs are regulatory tools that support Health Canada's oversight over the safety and effectiveness of a licensed medical device throughout its lifecycle.

The regulations give the Minister of Health the power to impose and amend T&Cs on a Class II to IV medical device licence at any point during the device's lifecycle. This will compel medical device licence holders to take steps to address the safety, effectiveness, risks and benefits of their device.

The use of T&Cs supports our ability to oversee and assess devices as well as enhance communications with licence holders throughout the device's lifecycle. The sooner that issues are identified, the sooner they can be addressed. The oversight provided through T&Cs and the reduction in risks and uncertainties will allow consumers to have continued access to medical devices that meet safety and effectiveness requirements.

Note that the regulations aren't changing the issuance requirements for medical device licences. When an application for a licence or a licence amendment is submitted to the Minister, the Minister determines whether the device meets the safety and effectiveness requirements of sections 10 to 20 of the MDR.

As required by subsection 36(1) of the MDR, it's only when these requirements are met that the Minister shall issue or amend a medical device licence. T&Cs aren't intended to enable the licensing of a medical device that hasn't met the applicable safety and effectiveness requirements.

Under the regulations, the Minister may, at any time, impose T&Cs on a licence, or amend those T&Cs.

The goal of imposing or amending T&Cs is to meet 1 or more of the following objectives:

• maintaining the safety and effectiveness of the device
  • by ensuring the device continues to meet applicable safety and effectiveness requirements under sections 10 to 20 of the MDR
• optimizing the benefits and managing the risks associated with the device
• identifying any changes relating to those benefits and risks and managing uncertainties related to the benefits and risks

Before imposing or amending a T&C, the Minister will first consider whether:

• there are uncertainties relating to the benefits or risks associated with the device
  • for example, although overall evidence demonstrates an acceptable benefit-risk profile, the benefits weighed against the risks may be less known in certain population subgroups
• the requirements under the FDA and its regulations 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 those objectives being met
• compliance with the proposed T&C is technically feasible
• there are less burdensome ways for those objectives to be met

The outcome of these considerations don't determine whether the Minister will impose or amend a T&C. Rather, the considerations help to inform the Minister's decision.

Note about guidance documents in general

Guidance documents provide assistance to industry on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements haven't been met.

As always, we reserve the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, effectiveness or quality of a medical device. We're committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of other applicable guidance documents.

About terms and conditions

Medical device licences may be issued with or without T&Cs.

The safety and effectiveness evidence required by the MDR to support a licence application is in proportion to the risk presented by the device. Prior to licensing, as required by subsection 36(1) of the MDR, the medical device must meet the applicable safety and effectiveness requirements of sections 10 to 20 of the MDR before we will issue a medical device licence.

T&Cs aren't intended to be used to address deficiencies in applications for a medical device licence. Once they have come onto the market, medical devices must continue to meet those same requirements.

Immediately after a device is licensed or when it comes onto the market, T&Cs may be imposed when there are uncertainties related to its risks or benefits.

Immediately after licensing, T&Cs may be imposed, for example, to:

• reduce uncertainties about predicted long-term safety and effectiveness where pre-market evidence isn't realistically available due to the intended duration of use of the device, such as in permanent implants
• obtain additional clinical evidence confirming that predicted outcomes are the same as tested populations for a population subgroup

After a device is on the market, T&Cs may be imposed, for example:

• when Health Canada becomes aware of new information about its real-world performance that creates uncertainty about whether the safety and effectiveness requirements of sections 10 to 20 of the MDR are still being met
• to require the collection of post-market information on a new or increasing risk that has been discovered after the long-term use of the device in order to facilitate post-market surveillance and risk monitoring

There is no limit on the number of T&Cs that may be imposed on a licence or the number of amendments that can be made to existing T&Cs. We take a case-by-case approach to imposing and amending T&Cs while also consistently applying regulatory requirements. Each T&C may also have a different deadline by which it must be fulfilled.

The following are some examples of what medical device licence holders may be required to provide through T&Cs:

• stability study results, such as real-time aging results
• new evidence from post-market studies
• performance data to confirm acceptable variations over time
• clinical data collected from under-represented groups
  • for example, to assess impacts based on sex or gender
• real-world evidence
  • for example, yearly submissions of sales and incident data in Canada or internationally
• clinical study results, such as:
  • in select cases, 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

Depending on the circumstances, T&Cs may be applied immediately following licensing, much later when the device has been on the market for some time, or both.

Imposing and amending terms and conditions

The following sections outline what to expect during the processes for imposing and amending T&Cs.

Proposed terms and conditions

In cases where a T&C is proposed immediately after licensing, we will notify the licence holder in writing that their medical device licence has been issued and will share the proposed T&C.

The licence is valid immediately, but the T&C will only come into effect after you have been given an opportunity to be heard. We will then notify you about the final T&C and when it is in effect. The licence will indicate that it's a licence with conditions.

If other T&Cs need to be added or if existing T&Cs need to be amended after a device has been on the market, we will inform you in writing about the proposed T&C. You will be given an opportunity to be heard before the T&C is finalized. We will notify you about the final T&C and when it is in effect.

We will inform you about the:

• issue that has been identified
• proposed T&C (new or amended), its objective, when it comes into effect and the timeframe for addressing it
• legal authority for imposing the T&C
• submission requirements to fulfill the T&C, instructions on what to include in the response and how to submit the response
• opportunity to be heard concerning the proposed T&C
• potential consequences of not complying with a T&C

Opportunity to be heard on proposed terms and conditions

Licence holders will be given an opportunity to be heard about a proposed T&C, whether it's a new T&C or an amendment to an existing T&C.

You will have up to 10 calendar days to submit a response to a T&C being proposed on your medical device licence. This doesn't mean that the activity required by the T&C must be completed in 10 calendar days. We will inform the licence holder when the T&C must be fulfilled.

During this period, you may notify us in writing about the T&C or submit suggested modifications to the T&C. For example, you may:

• suggest a modification and provide a rationale to support why the alternative is preferable
  • for example, proposing a new deadline because the information required won't be available until a later date
• comment on the technical feasibility of the proposed T&C
  • for example, where your ability to collect high-quality clinical data is impacted by the low rate of occurrence of rare disease states
• propose less burdensome means of achieving the T&C objective
  • for example, describing a study that requires fewer resources but would provide similar evidence

To notify us of any concerns about a proposed T&C or submit suggested modifications, email us at devicelicensing-homologationinstruments@hc-sc.gc.ca. In the subject line of the email, indicate the licence number and licence name.

Note: Imposing or amending T&Cs may follow a modified process in urgent situations. We expect that these urgent situations would occur infrequently. In rare cases where the health and safety of people in Canada may be severely compromised, we may give you a shorter timeframe (under 10 calendar days) to respond before imposing or amending a T&C on a medical device licence. If this happens, you will be notified that it's an urgent situation.

Considering submissions and imposing final terms and conditions

We will consider submissions received during the 10-calendar day opportunity to be heard window as part of the decision-making process for deciding to impose a T&C. We will inform licence holders of the final T&C in writing, including when the T&C comes into effect. Note that the timeline for a response from us about the final T&C may vary.

After a T&C comes into effect, you may email us if you have questions or concerns about your licence and its T&Cs. Contact us by sending an email to devicelicensing-homologationinstruments@hc-sc.gc.ca. In the subject line of the email, indicate the licence number and licence name.

Initiating amendments to terms and conditions

T&C amendments are changes to T&Cs that are already on a licence. For example, an existing T&C requires a clinical study. However, after coming to a better understanding of the device's benefits and risks, we may amend the T&C to change the scope of that clinical study.

In general, Health Canada initiates T&C amendments. As a medical device licence holder, you may also request an amendment to an existing T&C. When requesting, you must provide a:

• strong rationale for the proposed amendment
  • for example, a study can't be completed for scientific or technical reasons, such as when not enough people are enrolled in a planned clinical study
• detailed description of the proposed amendment

This information will help us decide whether to amend your T&C.

To request an amendment to an existing T&C, email us at devicelicensing-homologationinstruments@hc-sc.gc.ca. In the subject line of the email, indicate the licence number and licence name.

Timely communications

Providing current contact information will facilitate timely communication between licence holders and Health Canada. For example, when providing your licence contact information, we recommend using a generic email address as a central point of contact rather than individual email accounts.

Also, when you contact us about a T&C, use our device licencing email address: devicelicensing-homologationinstruments@hc-sc.gc.ca. In the subject line of the email, indicate the licence number and licence name.

Reviewing information submitted in fulfillment of terms and conditions

The following sections outline what you can expect when T&Cs are fulfilled.

Fulfilling terms and conditions

Once we receive satisfactory evidence in fulfillment of a T&C, we will contact the licence holder to confirm that the T&C has been fulfilled.

When all the T&Cs on a licence have been fulfilled, we will send the licence holder an updated copy of their licence. The licence will no longer indicate that it is a licence with conditions.

Adding terms and conditions

Removing a T&C after it has been fulfilled does not prevent us from imposing a new T&C on a medical device licence. We may impose a new T&C, for example, when we identify new risks or uncertainties that require a T&C. In such cases, we will provide details about the new proposed T&C to the licence holder in writing and follow the process described for imposing a T&C.

Transparency

To increase transparency and communicate risks to people in Canada, we will regularly publish information on T&Cs in both official languages. We will aim to update content regularly as T&Cs are imposed or amended (includes the removal of T&Cs).

We do not intend to publish:

• confidential business information, as defined in the FDA
• other information protected by law, such as:
  • personal information as defined in the Privacy Act
  • information that's protected by the Canadian Charter of Rights and Freedoms, section 8

We will also continue to communicate up-to-date information about medical devices using other sources of information, such as:

• Medical Devices Active Licence Listing: contains product-specific information on all medical devices that are currently or have been licensed for sale in Canada
• Medical device incidents: contains product-specific information on medical device incidents reported in Canada

Compliance and enforcement of terms and conditions

If you hold a medical device licence, as per Section 21.7 of the FDA you must comply with the T&Cs on your licence. It's an offence under section 31.2 of the FDA if you don't comply with a T&C.

We may pursue compliance and enforcement measures against licence holders who fail to comply with T&Cs, such as failure to submit study results in the specified timeframe.

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)

You may be liable to fines or even imprisonment.

We may take regulatory actions as a result of the information generated by the T&C. For example, we may order that a medical device be recalled if information indicates that it poses a risk to users.

For more information on compliance and enforcement measures in general, consult:

• Compliance and enforcement policy (POL-0001)
• Guidance on medical device compliance and enforcement (GUI-0073)