MedTech Regulatory & Quality Resource Hub

Supporting Dual Regulatory Pathways for Continuous Hormone Monitoring IVDs

Scaling 3D Printed Medical Devices for Global Health Impact

Fast-Track Regulatory Approval for a Visual Acuity App in Canada

Streamlining MDSAP Certification — Example of a Laser Therapy Ophthalmic Device

VR-Based Medical Device Case Study

2025 Wrap-up : Health Canada and other Jazz

As 2025 winds down, I wanted to share a summary of the key moments in the Canadian regulatory landscape and a couple thoughts on the US and EU.

Leaning into Interpretive Flexibility: Reflections from the 2025 Health Canada MedTech Conference (9-12 June 2025)

This phrase—delivered by one of Health Canada | Santé Canada’s senior regulators during Medtech Canada’s annual regulatory and quality conference in Ottawa last week—captured the tone...

Precision Regulating – Health Canada’s New Approach

The Regulatory Rapporteur 2025 first edition starts with changes at home, an exhaustive update on the Canadian Medical Devices Regulations SOR/98-282.

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

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.