Guidance on medical device compliance and enforcement (GUI-0073): Response to non-compliance
On this page
- Introduction
- Non-compliance with device licensing or authorization requirements
- Establishment licence non-compliance
- Non-compliance with stop sale for Class I medical devices and the requirement to provide additional information
- Non-compliance with advertising requirements
- Non-compliance with device-specific requirements, including labelling, safety and effectiveness
- Non-compliance with regulatory reporting and other regulated party-specific requirements
- Enforcement
Introduction
Guidance for actions to be taken in response to non-compliance is divided into the following groups:
- requirement for device licensing or authorization
- requirement for medical device establishment licensing (MDEL)
- requirement to provide information
- requirement to stop sale for Class I medical devices
- requirements for device advertising
- device-specific requirements, including labelling, safety and effectiveness
- regulatory reporting and other regulated party-specific requirements
The applicable sections of the Medical Devices Regulations (MDR) are indicated.
Non-compliance with device licensing or authorization requirements
Sections 26, 68.12, 70 or 80 of the MDR
This section applies to:
- devices subject to device licensing or authorization that have never been issued a licence (Part 1 of the MDR) or authorization (Parts 1.1, 2 and 3 of the MDR)
- devices sold under a private label, such as their own name, brand name or trademark, without a medical device licence (Part 1 of the MDR) or authorization (Part 1.1 of the MDR)
- licensed and authorized devices that have been subject to change requiring an amendment under sections 34 and 68.13 of the MDR and have not been issued an amended licence or amended authorization
- devices that have had their device licence or authorization suspended or cancelled and
- devices imported or sold under the special access, custom-made or investigational testing provisions of the MDR (Parts 2 or 3), which require an authorization and have not received one or have had it cancelled
Requirement to stop non-compliant activity
When Health Canada has reasonable grounds to believe that a medical device has been sold or imported without complying with the requirements of sections 26, 68.12, 70 or 80 of the MDR, we issue a regulatory letter. This letter is sent either by mail or email to regulated parties associated with the unlicensed or unauthorized device.
The letter instructs the regulated parties to stop importing or selling the device in Canada within 5 business days of receipt of the letter. They may also be asked to conduct an internal audit to identify and stop sale of any other unlicensed or unauthorized Class II, III or IV devices being sold or imported into Canada.
Depending on the risk to health and safety, we may take other actions to compel or induce compliance in order to mitigate those risks.
For more information on our enforcement activities, consult:
Requirement to notify customers or initiate a recall
Sections 63.2, 64 and 65 of the MDR
In the stop sale regulatory letter, Health Canada will require the manufacturer to provide written notification to all customers in Canada to whom they have sold the device. The notification must state that the device was sold without the appropriate licence or authorization.
Customers who are importers or distributors should also be advised to notify their customers and stop selling the unlicensed or unauthorized device. This notification could include end users if justified by the risk to health and safety.
Customers must be notified in writing. The notification must clearly indicate that the device has been imported or sold in contravention of the MDR. The customer notification, which constitutes a recall as defined in section 1 of the MDR, is required to be reported to Health Canada in compliance with sections 63.2, 64 and 65.
The definition of recall in the MDR includes recalls initiated voluntarily by a company and recalls ordered by the Minister.
Recalls are warranted in situations where the device:
- could cause serious injury to the health of a patient, user or other person (Type I recall) or
- is likely to cause injury to the health of a patient, user or other person (Type II recall)
For device licences or authorizations that have been suspended, cancelled or are subject to amendment, the recall notification must be sent to any party who has imported or sold the device after the:
- cancellation or suspension date or
- date when the amendment was required
To report a recall to Health Canada, consult:
Requirement for confirmation of actions taken
For stop importation and sale regulatory letters issued to a manufacturer, importer or distributor, the regulated party must provide written confirmation, on the included response form, within 5 business days. The confirmation must state that they have stopped importing or selling the affected devices.
If Health Canada does not receive this written confirmation within 5 business days of a stop importation or stop sale letter being received, we may initiate enforcement actions.
If a regulated party agrees to a stop sale but continues to advertise and sell in contravention of the MDR, Health Canada may take more stringent enforcement actions.
For non-compliances identified during an inspection, confirmation of stop importation or stop sale should be required by the closing meeting. If Health Canada does not receive confirmation, we may take enforcement action to prevent further non-compliant activity.
Stop importation and stop sale requests issued during an inspection are listed in the inspection summary section of the inspection report.
For access to information on medical device inspections, consult:
Reporting requirements for company-initiated recalls and recalls ordered by the Minister
Health Canada expects that regulated parties who sold unlicensed devices in Canada will inform their customers that the device was unlicensed so they have the option of discontinuing use.
As indicated previously, regulated parties who initiate a recall as a result of a stop sale letter are still subject to sections 63.2, 64 and 65 of the MDR. Failure to comply with these reporting requirements could cause Health Canada to take more stringent measures.
Any person who is ordered by the Minister to recall a device under section 21.3 of the Food and Drugs Act (act) must follow the specific reporting provisions described in section 65.2 of the MDR. Failure to report information to the Minister in a timeframe and manner that is consistent with section 65.2 or that is specified by the Minister may be subject to more stringent enforcement actions.
For more information on voluntary recall reporting and how to report ordered recalls, consult:
Record-keeping requirements
Manufacturers, importers and distributors must each:
- maintain distribution records (sections 52 to 55 of the MDR) and
- establish and implement documented procedures so they are able to conduct an effective and timely recall and investigation of reported problems (sections 56 to 58 of the MDR)
- retain recall records (sections 65.3 to 65.6 of the MDR)
Failure to comply with these regulations may result in compliance and enforcement actions.
These requirements permit Health Canada to:
- verify that a recall was timely and effective and
- ensure sufficient documentation is available for tracking the device, especially in the case of post-market issues
Non-compliance with any of the recall or distribution record-keeping requirements may result in enforcement actions.
Other actions
For devices that are unlicensed, unauthorized or have had their licence suspended or cancelled owing to non-compliance with the MDR, the regulated party should take additional actions to mitigate the risk. This may include removing the device from the Canadian market or sending out a public advisory.
Health Canada may also issue public notices for devices that are not in compliance with device licensing (part 1 of the MDR) and authorization requirements (parts 1.1, 2 or 3 of the MDR).
Establishment licence non-compliance
Under section 44 of the MDR, any person who imports into or sells a medical device for human use in Canada must have a medical device establishment licence (MDEL).
For more information, consult:
Importation and sale in contravention of section 44
Health Canada may issue a regulatory letter to a regulated party that imports or sells a medical device in Canada without an MDEL. The letter will advise them to cease conducting licensable activities until they apply for and receive an active MDEL. The regulated party must provide confirmation of actions taken in writing within 5 business days after the regulatory letter was issued.
If Health Canada does not receive a satisfactory response within 5 business days or an application for an MDEL has not been submitted, we may issue a final notification to the regulated party. This notification will once again indicate the non-compliance and state the actions that the regulated party must take.
If we do not receive a satisfactory response to the final notification within 5 business days, we may initiate enforcement actions.
Learn more:
Failure to renew an establishment licence annually and cancelled licences
Active MDEL holders must submit an annual licence review (ALR) application for their establishment licence before April 1 of each year (section 46 of the MDR). Regulated parties not wishing to renew their licence because they no longer conduct MDEL activities must submit an MDEL cancellation application asking for their licence to be cancelled.
Regulated parties that do not submit an ALR application or cancellation application before April 1 will have their establishment licence cancelled. They will have to submit a new MDEL application before they can resume licensable activities.
Health Canada will send the establishment a cancellation letter. The letter will:
- state that they are to immediately stop all licensable activities
- ask them to confirm in writing that they have ceased all licensable activities, including selling and advertising medical devices
An establishment that wants to resume licensable activities will have to apply for a new MDEL. We may verify compliance if we do not receive confirmation or we have reasonable grounds to believe licensable activities are still taking place.
We may take compliance and enforcement actions if the regulated party:
- does not submit a completed ALR application and
- continues to conduct licensable activities
Non-compliance with responsibilities for establishment licence holders
MDEL holders have a number of responsibilities, such as reporting incidents, notifying occurrences of foreign risk for medical devices, and reporting medical device shortages and discontinuations. These responsibilities are in addition to the requirement to have documented procedures in place, maintaining records and ensuring that devices are appropriately licensed and labelled.
Health Canada monitors and inspects MDEL holders to verify that written procedures are in place, confirms the type of licensable activities being conducted or confirms that activities have stopped after an MDEL cancellation. If we identify non-compliance, we may apply compliance and enforcement actions.
Learn more:
Terms and conditions for an establishment licence
Under section 48.1 of the MDR, the Minister may impose or amend terms and conditions on an MDEL holder that are additional obligations after considering certain factors. Terms and conditions may be imposed or amended either at the time the MDEL is issued or at any time throughout the lifecycle of the MDEL.
The regulated party must adhere to these specific terms and conditions. Failure to do so may result in the MDEL being suspended or taking other compliance and enforcement actions.
Refusal to issue an establishment licence
Health Canada will refuse an establishment licence if we have reasonable grounds to believe that issuing a licence would constitute a risk to the health and safety of patients, users or other persons. Failure to comply with any requirements of the act or MDR that may have an impact on health and safety may be considered to be such grounds.
The letter of refusal identifies the reason for the refusal. The applicant may seek an opportunity to be heard but may not conduct any licensable activities while waiting to be heard.
Suspension of an establishment licence
Health Canada may suspend an establishment licence if we have reasonable grounds to believe that:
- the regulated party has contravened the MDR or any provisions of the act related to medical devices
- the regulated party made a false or misleading statement when submitting their MDEL application
- not suspending the regulated party's MDEL would constitute a risk to the health and safety of patients, users or other persons
When Health Canada becomes aware that one or more of these conditions exists, we normally give the regulated party an opportunity to submit and implement a corrective action plan. We may deny this opportunity where immediate action is required to protect human health and safety.
If the regulated party does not respond or the response is inadequate, we may suspend their MDEL. In this case, we issue a letter of intent indicating that a recommendation to suspend the licence has been made under sections 49 or 50 of the MDR.
Suspension under section 49
The notice of intent to suspend a licence under section 49 of the MDR identifies the following:
- reason for the proposed suspension
- any corrective action that must be taken
- when it must be taken and
- process for giving the regulated party the opportunity to be heard
We will reference in the letter if the proposed suspension is based on:
- the outcome of an inspection or
- a failure to provide an adequate corrective action plan to address the observations identified during an inspection
Suspension under section 50
Health Canada may suspend an establishment licence immediately if suspension is required to prevent injury to the health or safety of patients, users or other persons (section 50 of the MDR). Before the suspension takes effect, we will issue a notice of suspension without giving the regulated party an opportunity to be heard.
Activities subject to the MDEL must stop as of the date of suspension.
The regulated party may request, in writing, that the suspension be reconsidered. Within 45 days of such a request, the regulated party is given an opportunity to be heard. The regulated party may not resume activities subject to the outcome of the hearing.
Regulated parties that fail to comply with a suspension notice are subject to immediate enforcement action.
Cancellation under section 51.1 of the MDR
An MDEL will be cancelled if the:
- licence suspension is for more than 12 months or
- licence holder has failed to submit an application for annual licence review (section 46.1(1) of the MDR)
Non-compliance with stop sale for Class I medical devices and the requirement to provide additional information
Class I medical devices are exempt from the device licensing requirements of sections 26 to 43 of the MDR. However, manufacturers must ensure that Class I medical devices imported or sold in Canada comply with the requirements of sections 3 and 19 to 21 of the act and the following sections of the MDR:
- safety and effectiveness (sections 10 to 20)
- labelling (sections 21 to 23)
- distribution records (sections 52 to 56)
- complaint handling (sections 57 to 58)
- incident reporting (sections 59 to 61.1)
- shortage reporting (section 62.23)
- recall requirements (sections 63 to 65)
If Health Canada asks for any of this information under sections 25(1) or 68.23 of the MDR and this information is not provided, the manufacturer, importer or distributor may be:
- required to stop sale (sections 25(2) or 85 (2)(a)) and
- subject to immediate enforcement action
Based on the level of risk to health and safety, a recall of devices may be required.
Non-compliance with advertising requirements
This section applies to:
- false, misleading or deceptive advertising for selling a Class I, II, III or IV medical device (section 20(1) of the act)
- advertising for sale of contraceptive devices (section 24 of the MDR)
- advertising for sale of an unlicensed or unauthorized Class II, III or IV medical device (section 27 of the MDR) or a device subject to a licence or authorization amendment (sections 34 or 68.13 of the MDR)
- advertising for sale of Class I medical device without an establishment licence (section 44 of the MDR)
- advertising for sale of a Class I authorized device subject to change in medical condition, purpose or use without an amended authorization (68.13 of the MDR)
- advertising for sale of investigational testing devices (section 87 of the MDR)
- advertisements that may pose a significant safety concern (section 20(1) of the act)
- advertising to the general public for a cure or prevention of Schedule A.1 diseases (section 3(1) of the act)
Advertising a medical device encompasses any form of media, such as:
- online
- for example, website, email, apps, social media
- radio
- television
- direct mail
- mass print
- for example, newspapers, magazines, billboards
- point-of-purchase materials
When there is evidence that a medical device has been advertised without complying with the requirements of the MDR, Health Canada may issue a regulatory letter to the responsible advertiser. The letter will request that the non-compliant advertisement be removed or amended.
If non-compliance persists, we may take further enforcement action based on the risk associated with the advertisement and the response that we receive.
Non-compliance with device-specific requirements, including labelling, safety and effectiveness
Medical devices offered or imported for sale or use in Canada must meet the labelling requirements listed in sections 21 to 23, 75 and 86 of the MDR.
For more information, consult:
Non-compliance with device labelling requirements
Sections 21 to 23, 75 and 86 of the MDR
Non-compliance with labelling requirements can be identified throughout the distribution chain (including importers, distributors and retailers). The manufacturer, however, is ultimately responsible for ensuring that the label meets the regulatory requirements. All parties involved with the distribution chain are expected to work together to resolve the label deficiency.
Label deficiencies are identified as follows:
- during an MDEL inspection
- documented as observations in the inspection report for importers or distributors
- importers or distributors work with the manufacturer to provide an adequate corrective action plan and timeframe for correcting the label to Health Canada
- when verifying medical device compliance
- the regulated party is issued a regulatory letter
- the manufacturer is responsible for amending the device label
If the label change for a Class III or IV medical device is significant, a licence or authorization amendment must be approved by Health Canada before the label is amended and the device can continue to be sold. Depending on the level of risk or uncertainty posed by the non-compliant device label, additional compliance actions may be required, such as stopping the sale of the product or recalling the product.
If the manufacturer's original device labelling or packaging is altered by an importer, distributor or retailer, it may change the licensing or authorization status of the medical device. As the manufacturer is ultimately responsible for information on the label, Health Canada may contact the manufacturer to confirm that they authorized the modified label.
Health Canada may ask the regulated party to stop selling or importing the device if the importer, distributor or retailer has made changes to the label that:
- contravene sections 21 to 23 of the MDR or
- are outside the licensing or authorization
Non-compliance with safety and effectiveness requirements
Sections 10 to 20 of the MDR
When Health Canada identifies a non-compliance that may impact the safety and effectiveness of a medical device, we will advise the manufacturer of this non-compliance.
The manufacturer will be required to take actions to address any potential risk to health, such as:
- stop importing and selling the affected device until compliance is achieved
- conducting a risk assessment to determine the level of risk associated with the safety issue
- conducting an investigation, including root cause analysis, providing recommendations on the findings, and proposing a corrective action plan to mitigate the risk
- advising on the number and rate of occurrences and the severity or impact of the issue
- recalling the device, which may include removing it from use or making changes to mitigate the risk
- amending or cancelling a device licence or authorization
- taking preventive action to achieve and maintain compliance
If any of these actions cause there to be a shortage of medical devices in Canada, the manufacturer is required to advise Health Canada as part of their corrective action response.
Depending on the level of risk, we may:
- conduct a health hazard evaluation or risk benefit analysis to assess risk to health and advise the regulated party to follow any recommendations made
- post a public advisory or safety alert to notify the public of the issue or
- monitor the issue over a period of time
Regulated parties that do not conduct appropriate actions in a timely and satisfactory manner are subject to enforcement action under the MDR. This can include the following:
- issuing information requests (sections 25 or 39)
- suspending a device licence (sections 40 or 41)
- suspending or cancelling an establishment licence (sections 49 to 51)
- suspending an MDEL for Class I manufacturers (section 49)
Non-compliance with regulatory reporting and other regulated party-specific requirements
Sections 52 to 59, 61.2 to 61.3, 62.23 and 63 to 65
The regulated party is advised to take immediate action under the following cases:
- to correct non-compliance with the reporting requirements or
- where they have not complied with a requirement of the act or MDR that concerns a procedure or action for which they are responsible
The following are some examples of non-compliance, when a regulated party fails to:
- keep and retain records for the appropriate period
- investigate complaints (or does so inadequately) or lacks an internal complaints process
- report an incident
- submit a foreign risk notification
- report an anticipated or actual medical device shortage
- report a recall
- identify when a recall is required
- conduct recall actions to address unsafe and ineffective non-compliant devices
- have the required documented procedures or makes a false attestation regarding procedures
A regulated party may also be subject to enforcement action if they:
- are not able to take the required corrective action because of a lack of record keeping or documented procedures are absent or deficient
- make a false attestation
- are unwilling to take such actions
Enforcement
Health Canada uses a risk-based compliance and enforcement approach that is informed by information pertaining to non-compliance.
Based on the severity of risk to public health and safety posed by non-compliance, Health Canada identifies the most appropriate action or tool to achieve compliance and mitigate the overall risk. If non-compliance persists, additional actions will be taken that will evolve towards stronger compliance and enforcement actions.
Visit the section on compliance and enforcement actions and tools.
Compliance and enforcement activities include:
- promoting compliance or educating about regulatory requirements
- taking corrective actions
- stopping the import, sale and advertising on a voluntary basis
- stopping or preventing the import, sale and advertising of non-compliant devices
- conducting a voluntary recall
- publishing alerts, advisories or other risk communications
- disclosing information, such as inspection reports, to the public
Additional enforcement actions may include:
- issuing a warning letter
- seizing or detaining a device or consenting to forfeiture
- recommending the refusal or seizure of imports at the border
- ordering recalls or stop sales to take preventive and remedial measures
- suspending or cancelling a medical device licence
- adding terms and conditions to MDELs
- refusing, suspending or cancelling MDELs
- imposing financial penalties
- applying for injunctions
- recommending prosecution
In general, regulated parties are given an opportunity to take action in response to non-compliance.
However, enforcement actions may be taken at any time during or after inspection or compliance verification when circumstances warrant. Such circumstances include a lack of cooperation or an inability to address the non-compliance, whether intentional or unintentional.
It is important that regulated parties respond to:
- written notices (regulatory letters or warning letters)
- orders from a judiciary court for recalls or stop sale
- inspection reports
- letters requesting specific compliance actions, such as:
- recalls
- stop sale or advertising
- incident reports
- licence amendments
Failure to do so is interpreted as an indication that the regulated party does not intend to voluntarily comply and that enforcement action is required.
Regulated parties with a history of failure to provide adequate response to non-compliances may be subject to immediate enforcement action.
Enforcement is undertaken only when and if devices, activities and processes do not comply with the act and the MDR. This may also include when an inspection indicates that sections of the act have been contravened. For example, section 23(13) requires that inspectors be given reasonable assistance and be provided with any information they may reasonably require.