What are Mira's certifications and regulatory approvals? (FDA, CLIA, Health Canada, etc.)Updated 2 months ago

Mira meets rigorous international quality and regulatory standards for medical devices.

United States

Mira is an FDA-registered Class I medical device. It is designed for at-home use and does not require CLIA certification, as it is not a laboratory-based test.

While Mira is not “FDA-cleared” (a designation reserved for higher-risk diagnostic devices), it is compliant with FDA regulations for low-risk wellness and fertility monitoring tools. The technology used in Mira has been clinically validated and supported by peer-reviewed research.

Canada
Mira is licensed by Health Canada as a Class II In Vitro Diagnostic (IVD) medical device, confirming that it meets Canadian regulatory requirements for safety, effectiveness, and quality.

Quality & International Compliance
Mira meets the highest standards for medical devices: 

• ISO 13485 Certified: Ensuring top-tier medical device quality & compliance.
• MDSAP compliant: Meeting regulatory requirements across the US, Canada, and Australia.

Quanovate Tech, Inc. has been registered by Intertek, an MDSAP-recognized auditing organization, as conforming to the requirements of: 
ISO 13485:2016
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1(excluding Part 1.6)
Canada: Medical Devices Regulations – Part 1- SOR 98/282
United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)