June 28, 2021
Health Canada CMDR Updates 2021
Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021:
- Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to them upon request regarding device risks/problems, etc. Generally, this won’t require any changes in our QMSs, but we can certainly add QMS coverage voluntarily to assure the organization is ready to cooperate in the event such Health Canada demands are made.
- Effective 23 June 2021, Canada’s Mandatory Problem Reporting requirements change in three ways and we need to have our Mandatory Problem Reporting procedures revised accordingly:
- Canadian “Mandatory Problem” reporting is now Canadian “Incident” reporting.
- Foreign incident reporting is now limited to Class I devices; yet
- Class II, III, and IV foreign incident reporting has been replaced with a new process called “Foreign Risk Notification”.
- Effective 23 December 2021, Health Canada will require a certain type of post-market surveillance and a report called a “Summary Report” which may in certain circumstances require submission to Health Canada within 72 hours. An associated seven-year record keeping requirement is included. Corresponding procedures should be integrated into our QMS procedures for PMS. I found that Canada’s new PMS requirements can be met by leveraging certain PMS tasks already being done for the EU MDR, and then adding a few tweaks. I also recommend a designated “Summary Report” template be used for the Canadian Summary report, as the particular conclusions and analyses required for Canada are unique compared to the EU MDR’s PMSR and PSUR.
- The aforesaid changes were brought about via a SOR/2020-262 which conveys the series of regulatory amendments for SOR/98-282 (as well as for the Food and Drug Regulations C.R.C., c. 870). The SOR/98-282 changes that took effect on 23 June 2021 are expected to be incorporated into the Justice Laws website version within a couple weeks. The SOR/98-282 changes that will take effect 23 December 2021 will likewise be integrated in due course thereafter. The title of SOR/98-282 (Medical Devices Regulations) will remain unchanged.
A good place to document consideration of applicable new or revised regulations is during management review. For example, consideration of such regulatory changes is required as a management review input under ISO 13485 clause 5.6.2(l); a similar approach can certainly be applied even if it is not an ISO 13485 QMS. It would be sufficient to record a high-level summary of such changes, and then a general implementation plan/timeline. This would also be a good place to state the aforesaid relationship between SOR/2020-262 and SOR/98-282.