Big news for anyone tracking their hormones in Canada. Mira has received its official Health Canada Medical Device Licence — and here's why that matters.
We have big news to share
As of May 2026, Mira has been officially licensed by Health Canada as a Class II In Vitro Diagnostic (IVD) medical device. This means the Mira Hormone Monitor and Wands have met Canadian regulatory requirements for safety, effectiveness, and quality.
In plain terms: Mira isn't just a wellness gadget. It's a regulated medical device you can trust.
What Is the Mira Hormone Monitor?
If you're new here – welcome. Mira is a at-home hormone monitor designed for anyone who wants real, quantitative data about their reproductive health.
Unlike traditional ovulation tests that give you a "peak" or "not peak" result, Mira measures your actual hormone levels – LH, E3G, PdG, and FSH – and tracks them over time through the Mira app.
Who is it for?
- People trying to conceive who want precise ovulation tracking
- Those managing conditions like PCOS or irregular cycles
- Anyone who wants a deeper understanding of their hormonal health across their cycle
- People who want to understand how their hormones are changing with age – whether they're noticing early shifts, navigating perimenopause, or tracking through menopause
Mira is trusted by over 300,000 women worldwide – and now, it carries the official licensing to back that trust in Canada.
What Does "Licensed by Health Canada" Actually Mean?
Health Canada is Canada's federal health authority. When a medical device receives a Health Canada Medical Device Licence, it means the product has been:
- Reviewed for safety, quality, and intended use
- Assessed to confirm manufacturing and quality systems meet regulatory standards
- Authorized for sale in Canada as a medical device
This is the same regulatory body that oversees pharmaceuticals, vaccines, and medical equipment used in hospitals. Getting a Class II Medical Device Licence is not a rubber stamp – it's a meaningful signal that the product works as intended and has been built responsibly.
Why Does This Matter to You?
The fertility tracking space is crowded, and not every device on the market is held to the same standard. Now, as a Canadian customer, you can choose Mira with the added confidence that it's been reviewed and licensed by an independent federal authority.
Whether you're just starting your fertility journey or you've been tracking for years, that matters. It means the data you're getting from your Mira is coming from a device that meets the bar for a regulated medical product — not just a consumer wellness app.
Available Now in Canada
Mira is available for Canadians through miracare.com. The Mira Hormone Monitor: Ultra4 Kit includes the hormone monitor, 4-in-1 wands, and access to the full Mira app experience.
Mira is licensed by Health Canada as a Class II In Vitro Diagnostic medical device.
