Guidance on medical device compliance and enforcement (GUI-0073): Compliance and enforcement
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Guiding principles
Compliance and enforcement activities for medical devices are based on guiding principles.
Consult:
Where justified by circumstances and supported by sound rationale, alternate actions or approaches to those specified in this document may be considered.
Actions and tools
The choice of a compliance and enforcement action and tool is in proportion to the risk posed to public health and safety by a medical device.
The framework outlines the different levels of compliance and enforcement actions and tools depending on the decision factors used to assess risk. Some activities are designed to help regulated parties understand their responsibilities. Other activities are designed to induce or compel compliance with the Food and Drugs Act (act) and Medical Devices Regulations (MDR).
The main decision factors include:
- degree of risk to health and safety posed by the non-compliance
- behaviour of the regulated party, such as deliberate or accidental non-compliance
- compliance history of the regulated party, such as frequent or rare non-compliance and
- other factors, such as device classification, significance of the non-compliance, population affected, vulnerabilities, short in supply
Actions and tools fall under 3 main categories:
- Compliance promotion
- providing education and guidance on the regulatory requirements for medical devices to users and regulated parties
- Compliance monitoring
- conducting inspections
- administering licences
- reviewing documents
- verifying compliance in response to reports, complaints and adverse reactions
- Enforcement actions
- preventing the sale, import, advertisement or manufacture of non-compliant devices
- publishing advisories
- requesting voluntary recalls or other changes, such as labelling or advertising updates
Risk management
Health Canada uses a risk-based approach to inform the choice and timeliness of compliance and enforcement actions.
A risk-based approach involves:
- identifying risks associated with the device deficiency
- assessing the level of risk
- implementing measures to control or mitigate the risk and
- managing the risk with appropriate compliance and enforcement actions
This process can be repeated to ensure that the risk posed by the medical device non-compliance is at an acceptable level.
Health Canada relies on 3 main approaches to reduce risks posed by medical devices:
- Regulatory pre-market application requirements under Part 1 of the MDR for Class II to IV devices, including a review of safety and effectiveness information for Class III and IV devices
- pre-market authorization requirements under Part 1.1 of the MDR for Class I to IV devices on the List of medical devices for an urgent public health need, including the review of safety and effectiveness information for Class III and IV devices
- regulatory application requirements for Class II to IV medical devices authorized under Part 2 (custom-made or special access) and Part 3 (investigational testing)
- Collecting and assessing medical device incidents submitted by industry, hospitals, health care providers and the public
- Compliance and enforcement activities after the devices have been imported or sold in Canada
The principal mechanisms that the MDR uses to provide assurance of compliance with these requirements are as follows:
- device licensing and authorization for manufacturers of Class II, III and IV medical devices and
- establishment licensing for importers, distributors and Class I manufacturers
Non-compliance with device licensing or authorization requirements presents a potential risk to health and safety since it circumvents the premarket review required before devices are authorized for sale.
Non-compliance with licensing, authorization or establishment licensing requirements means that regulated parties may not be able to adequately identify or take appropriate corrective action for unsafe or ineffective devices they have manufactured, imported or distributed. Failure to comply with post-market requirements, such as recall reporting, incident reporting, shortages reporting or investigating complaints, may also pose a risk to health and safety.