Summary reporting provisions of the Medical Devices Regulations: Notice to industry
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Background and purpose
The amended Medical Device Regulations (regulations) that describe summary reporting provisions have been in effect since December 23, 2021. Health Canada wishes to remind manufacturers of these requirements.
If you hold a Class II medical device licence, you must have summary reports prepared by December 23, 2023. If you hold a Class III and IV medical device licence, you must have summary reports prepared by December 23, 2022.
Learn more about these requirements:
Regulatory flexibility
Health Canada understands that some of you are finding it difficult to implement the summary report provisions within the required timelines.
We understand the pressures caused by the pandemic and know that manufacturers are working toward meeting the timelines.
To ensure continued access to licensed medical devices in Canada, we will be placing less priority on enforcing the summary reporting provisions at this time.
We will assess implementation issues on a case-by-case basis, taking into account:
- your overall compliance, and history of compliance, with the regulations
- you are making an effort to implement systems to comply with the summary reporting provisions
We may ask you to file an implementation plan and provide regular status updates.
Please note, however, that non-compliance with the summary report provisions could affect your existing or new certification under the Medical Device Single Audit Program. You are encouraged to identify the issue as a preventive or corrective action in your quality management system. By being proactive, you may reduce the likelihood of your auditor citing nonconformities and potentially having your certificate suspended.
If you have questions about this notice, please email us at mdd.postmarket-postcommercialisation.dim@hc-sc.gc.ca.