Key takeaways from Canada's Annual Regulatory and Quality MedTech Conference (23-24 April 2024)

Hello everyone,

I am once more struck by the relaxed atmosphere, the partnership between industry and regulators and shared interest to address the needs of a small market while considering global implications.

1. US FDA + Health Canada: a mature regulatory collaboration model

The reliance efforts between both departments are so undeniable, it got me wondering if we are not going towards a Medical Device free movement zone.

Although not a single submission yet, the shared eSTAR platform is certainly gaining traction bringing both jurisdictions even closer. I was also surprised to learn that the Canadian REP (Regulatory Enrollment Process) website will be hosted on FDA servers.

It is important to note that although eSTAR and REP can work together, they are independent from each other. eSTAR is a submission builder, while REP replaces the licence application process. Health Canada reassured industry that the timelines to launch each one will not influence the other, including the awaited final eSTAR ToC which is expected to be released soon after IMDRF’s ToC guidance is published.

Please note, Health Canada will be running REP demo days in August 2024, but the program will only be mandatory in 2026.

I was also pleasantly surprised to learn that the US FDA was the one to invite Health Canada to co-Chair the SaMD IMDRF working group. What a great opportunity for both countries to learn from each others’ differences in scale, industry maturity level and tools available to regulate this very important segment of medical devices.

2. Significant change to the significant change guidance

Another vividly discussed topic, particularly the “retiring" of decision flowcharts found not compliant with the Canadian government written communication policies; too simplistic, and in some cases misleading. Health Canada confirmed that the guidance was almost entirely rewritten with a new section on ultrasound devices aligning the definition of significant change for these devices with that of the US FDA. This is expected to significantly reduce the number of regulatory amendments required to implement changes in these devices.

3. Please (Health Canada) implement UDI regulation!

An excellent presentation by Becton Dickinson's UDI Program Director, Dennis Black, focused on explaining the global state of UDI implementation, and the crucial understanding that UDI is not only a regulatory requirement but a tool of import to all industry functions from Sales & MKT to Supply Chain with a deep impact on Quality Management Systems and regulatory compliance all the way to recalls and post-market surveillance effectiveness.

UDI is a “long-term project” for Health Canada, this is regrettable given the tangible impact it can have on patient safety and the recent post-market compliance enforcement issues. Health Canada did confirm however their intent to align with global requirements. It remains to be seen how the federal organization plans to track UDI compliance at the provincial level.

4. IMDRF, MDSAP, GMDN, QSMR and the harmonization dream

It was interesting to hear Health Canada’s input on the impact of the FDA leaving GHWP (Global Harmonization Working Party) and IMDRF’s shift from being a regulators’ only forum to actively recruiting industry associations.

I have repeatedly written about the growing influence of the MDSAP program from shortening approval times in Brazil to reducing direct audit surveillance by the FDA. The program is finally “graduating” from FDA’s website, Australia’s TGA has in fact taken on the task to build a new website for the program which speaks of the intent to give the program a brand that reflects its global reach and ambitions.

Industry moaned the lengthy process to get MDSAP certifications, 6 to 12 months from application submission to assigning auditors to certificate issuance. Health Canada being the only member of the program requiring a certificate where others rely on auditing the audit report.

With membership applications on the rise, the program is actively recruiting members while being cognizant of the limited Auditing Organizations capacity and working to develop these in parallel.

The age-old question was back on stage again, why is the MDSAP program mandatory in Canada? Why?

The answer is pretty simple indeed. Prior to the MDSAP program, Canada had CAMDCAS which allowed Health Canada to require additional regulatory requirements on top of the ISO 13485 certification. Other jurisdictions thought it was a great idea and came up with MDSAP to allow for certification against the ISO standard while accounting for local requirements.

In short, nothing changed in the QMS requirements to market medical devices in Canada, the real question is why other jurisdictions did not make MDSAP mandatory? Particularly, when considering the increasing need for reliance and the positive impact MDSAP had on trust building between participating jurisdictions paving the way for harmonization.

As for “MDSAP is too hard to obtain” myth, once more data showed that the top ten deficiencies raised during MDSAP audits were all ISO 13485 (and not local requirements) related.

QMS certificate scope not matching actual activities or device type, risk classification and significant change remain Health Canada’s highest cause of issuing AIs (Additional Information requests) during the licence application review process. Work is being done at the Medical Devices Directorate to align certificate scopes with GMDN (Global Medical Device Nomenclature). The aim is to reach a precise enough scope, not so precise that it is down to the sub-model, to reduce disagreements between AOs and Health Canada.

Last year, Health Canada mentioned their plans to revise the risk classification of medical devices and retire the keyword index document. The new device classification will also rely on the GMDN code while significant changes are expected to drop following the release of the new significant change guidance.

The QSR is to be retired on its 50th day. The US FDA will not provide QMSR certificates, nor accept MDSAP or ISO certificates for QMSR compliance equivalence. Instead, the agency plans to audit MDSAP audit reports and is likely to implement the MDSAP audit model.

5. Alberta’s monumental changes to the healthcare system

The Albertan government will be getting rid of the Alberta Health Services to reduce cost (highest in Canada), decentralize and reduce pressure on acute care.

The new structure will have Primary care, Continuing Care, Mental Health and Addiction and Acute Care organizations all report directly into the Ministry of Health.

6. Bill C-244 amendment to the Copyright Act

This bill clears the way to the Right-to-repair including for medical devices which are federally regulated products while “servicing” is not. Concerned with the impact of this amendment on product safety and effectiveness, MedTech Canada together with its members has been advocating for the creation of a quality system framework that enables Vanessa’s law to work as intended.

7. Conclusion

Although a small size market, Canadian #MedTech is growing faster than initially projected. Health Canada’s strong relationship with the US FDA and commitment to global harmonization place the country at the forefront of important regulatory conversations.

While Europe is toying with an EU-MDRexit, the US FDA, Health Canada, the UK, Switzerland, and Australia are joining efforts to strengthen regulatory reliance through MDSAP, shared submission platforms like the eSTAR and deepen the collaboration between industry and regulators through IMDRF.

Finally, Health Canada will continue to focus on developing agile regulations while addressing new priorities such as private labelling. Unfortunately, my question on Health Canada’s plans for combination devices remained unanswered due to lack of time but there does not appear to be any work done on that front yet.