Foreign risk notification for medical devices guidance document: Monitoring, compliance and enforcement
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Manufacturers and importers are encouraged to collect safety information in ways that promote compliance with the requirement to notify Health Canada of notifiable actions. This may include facilitating timely communication between themselves and their counterparts operating in the relevant jurisdiction.
For example, the monitoring process for manufacturers and importers may include:
- monitoring information sources from listed regulatory agencies for relevant actions (for example, communicating risks, making changes to labelling, recalls)
- scanning for information on “serious risk of injury to human health” related to the safety of a medical device
However, actions that are monitored should be consistent and follow a documented procedure in a way that promotes compliance with the Regulations.
Compliance and enforcement
The new amendments to the Medical Devices Regulations will not alter existing compliance and enforcement mechanisms under the provisions of the Regulations.
Health Canada will work with manufacturers to achieve compliance with all regulations by addressing issues and providing the necessary guidance documents and templates.
The manufacturer and importer should have in place and maintain records of a monitoring process, which we may assess when verifying compliance. Records could include, for example:
- a documented process for the receipt, assessment and reporting on notifiable actions (includes relevant quality documents, such as standard operating procedures)
- complete operational records so the regulator is able to determine compliance (for example, showing information received and assessed, decisions and actions taken)
Health Canada may also verify compliance by reconciling incoming reports with the information we collect through other means. Information may include mutual recognition agreements with foreign regulatory authorities or environmental scans done by Health Canada.
In the case of non-compliance, we may take compliance and enforcement action in accordance with the risk-based approach outlined in the compliance and enforcement policy for health products (POL-0001). If non-compliance isn’t resolved, Health Canada may apply the provisions of the Food and Drugs Act and its associated regulations (sections 61.2 and 61.3, and outlined in the policy).
When determining which enforcement measures are appropriate, for the purposes of sections 61.2 and 61.3 of the Regulations, we consider whether non-compliance poses a serious health risk to Canadians.
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