Canadian regulatory news for medical devices and IVDs
In case you missed it, the Canadian Medical Devices Regulations were quietly updated in December 2020. The new regulations aim to enhance post-market safety and require manufacturers to submit a safety report. synthesis, which is similar to the periodic post-marketing benefit-risk ratio. Assessment Report (RPEAR) required for pharmaceutical products in Canada. This new requirement comes into effect on December 18, 2021.
If you are marketing products in Canada, it is important to know that you can lose your license if you do not comply. Health Canada is also historically very rigid when it comes to timelines, so don’t expect an extension unless you get the regulator’s approval.
What are the current requirements?
Manufacturers of medical devices currently have limited requirements for regular reporting after a product has been placed on the market. Recalls, serious events, vigilance events and certain other types of information must be reported, and manufacturers must respond to requests from Health Canada.
What are the new requirements?
The amendments to the Medical Devices Regulations published in the Canada Gazette, Part II (GCII) in 2020 are:
- Preparation, retention and submission of summary reports for Class II, III and IV devices under sections 61.4, 61.5 and 61.6
- Completion of safety and efficacy analyzes related to issues under Articles 25.6 and 39
SUBMIT SUMMARY REPORTS
Much like the Periodic Security Update Report (PSUR) in the EU, a synthesis report is intended to provide an overview of what is happening with the device in the market and its impact on the benefits or advantages. risks of using this device. Summary reports must be submitted every two years for Class II devices and annually for Class III and IV devices. Manufacturers should report any adverse events that have occurred with the device and anything that has been reported by the importer or distributor. Customer complaints should also be included from within Canada and wherever else the device is sold. One possible outcome is that manufacturers may have to change labeling or warnings as a result of the report.
CREATE PROBLEM-RELATED ANALYZES
These reports are usually triggered by Health Canada if there has been an incident, a customer complaint, or any other reason to suspect that the device may not meet requirements for safety and efficacy. The report should include:
- Device complaints and incident reports
- Clinical data and other evidence
- Exhibition data or sales data
- Trends in device malfunctions, quality issues, and results of other analyzes
- A conclusion
Typically, problem reports should be submitted within 30 days, and sometimes less if there are concerns about a serious risk.
What should manufacturers do before December 18, 2021?
As of this date, your quality management system must meet the new requirements for summary reports and analyzes related to problems. Health Canada has not said that the first reports must be completed, but the law takes effect on that date, and manufacturers should be prepared to at least comply with a plan that sets a timeline for completion. You absolutely must plan to have summary reports for Class III and IV devices by December 2022.
For manufacturers who also sell in the EU, you are largely in compliance with Canadian regulations if you meet all the requirements of the PMS plan and PSUR required by the EU MDR. In fact, if you have an EU MDR PSUR and add Canadian sales and information, you can use just one report to satisfy both regions. Manufacturers who sell only in Canada may have work to do to prepare for the new requirements.
How do PSURs and Synthesis Reports compare?
Canada has acknowledged that it will accept a report from another region as long as you meet the specific Canadian requirements, so you can change your PSUR for Health Canada. However, it is important to be aware of these differences regarding the summary report if you take this approach. Important distinctions include:
- Events and sales should be presented by region
- Sale and incident rates must be included for Canada
- The document must refer to the Health Canada regulations
- Records must be kept for seven years
Problem-related analysis is generally not included in the PSUR and requires a more focused response.
What are some practical tips for manufacturers selling IVDs and MDs in Canada?
Whether you have a PSUR that you can adapt or need to start from scratch, follow these tips for a more efficient submission process.
KIT OF EQUIPMENT FOR EFFICIENCY
Health Canada allows you to consolidate devices into a single summary report, so take advantage of this efficiency when needed. Keep your groups aligned with product families and be aware of your product lifecycles. Avoid bundling products that will be taken off the market.
UNDERSTANDING YOUR SALES DATA
Understand how your sales are reported on the business side. Sometimes the way they are credited in different regions is different from the way you group them together in your report.
PAY ATTENTION TO ADMINISTRATIVE DETAILS
Have good control over product names (aliases) and be consistent with other documents. It might sound simple, but it can trip people up as the devices sometimes have different names in different regions.
UNDERSTANDING YOUR ADVERSE EVENT DATA
Be aware of how you group adverse events and make sure the terminology is aligned, as this could affect the way you conduct your data analysis. For example, if the patient complaint data refers to “inflamed red skin” but the clinical data indicates “infection”, the data analysis could be inaccurate if the terminology is not reconciled.
DO NOT DELAY
Start soon and try to create a summary report. It will take longer than you think to create it (even with the PSUR).
PREPARE THE RESULTS
Be prepared to follow up on any issues discovered while preparing a summary report. Make sure you have mechanisms in place to make changes if necessary, including labeling, registration, instructions for use, etc.
What resources can manufacturers use for advice?
The best reference resource is the Canadian guidance document “Advice on summary reports and analyzes related to medical device issues.“Manufacturers should also stay tuned for EU PSUR advice, as they could provide relevant advice as well.
If your team is having difficulty with PSURs in the EU or Synthesis Reports in Canada, RQM + is here to help. Contact us today to find out more and consult our Knowledge center for more content from our experts.