Overview of the ‘new’ Canadian Regulation SOR/2020-262 (In force 12/23/21)

Overview of SOR/2020-262 Video

SOR/2020-262 was released in draft in December 2020 as part of a 2-part implementation. Most recently, on December 23rd, 2021, the 2nd part of the implementation became effective, which were the sections dedicated to Post-Market Surveillance.

One of the changes includes verbiage. Previously the term used was “mandatory problem reporting”. This has been changed to “incident reporting”. Although the spirit of changes like these often change little to their intentions, they easily become ‘buzz words’ that demonstrate to auditors how diligently you are maintaining your quality management system documentation. Therefore when regulations update the terms used within their text, it is also best practice to update the terms referenced within your quality system.

In addition, “Regulatory Agency” was officially defined as, “regulatory agency means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of medical devices within its jurisdiction and that may take enforcement action to ensure that medical devices marketed within its jurisdiction comply with the applicable legal requirements. (organisme de réglementation)”. So, if an auditor sees you still using ‘mandatory problem reporting’, and you can’t provide a definition for what a regulatory agency is, it will be assumed that you probably aren’t adequately maintaining your quality system.

There is also a requirement to provide a written “Issue-Related Analysis of Safety and Effectiveness” for any changes to benefits and/or risks of devices being sold on the Canadian market. For those out there that use Medical Device Academy’s Quality System Documents in their own QMS, please refer to the template TMP-045 ISSUE-RELATED ANALYSIS OF SAFETY & EFFECTIVENESS from the parent procedure SOP-019 Post-Market Surveillance procedure. This procedure and template have also been explicitly updated to include SOR/2020-262 and is available for sale on our website- https://medicaldeviceacademy.com/post-market-surveillance-procedureform/

Foreign Risk Notification also clarifies that some reporting requirements are specific to devices that are sold in Canada not that the incident or risk must have occurred in the Canadian market. These reporting requirements vary depending on the risk classification that Health Canada has assigned the device and may apply to both manufacturers and importers of the medical device. As a broad example if a manufacturer sold a device both in Canada and the United States of America and reported an incident to the U.S. FDA that occurred within the jurisdiction of the U.S. FDA only, Health Canada would also require notification because that same device is available on the Canadian market.

The authority of the Minister of Health has also been clarified. The Minister has the authority to suspend distribution and establishment licenses for noncompliance.

Link to Health Canada Website here if they ever update it, last update was 12/13/21!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Additional Resources-

Health Canada Regulations Amending the Food and Drug Regulations and the Medical Device Regulations (Post-Market Surveillance of Medical Devices): SOR/2020-262