Cardihab achieves TGA Class IIa and ISO certification

Cardihab Digital therapeutic has been proudly registered with the Australian Register of Therapeutic Goods (ARTG) as a Class I medical device since December 2020. In response to the up regulation of Software as a Medical Device (SaMD) products to class IIa or higher depending on the intended use, we are proud to announce we have achieved our Class IIa registration and the associated certification to ISO 13485:2016 as well.

These milestones aren’t just regulatory checkboxes. They are a signal of our commitment to quality digital health solutions, patient safety and evidence-based innovation. They demonstrate that Cardihab’s solutions meet the rigorous standards set by the regulatory authority for quality, safety, and clinical effectiveness. For healthcare providers and partners, this means:

Confidence through compliance - Cardihab has passed a rigorous, multi-year assessment by the Therapeutic Goods Administration (TGA), ensuring our solution meets strict medical device standards.
Assurance of quality systems - ISO 13485 certification confirms our Quality Management System is aligned with global best practice for medical devices.

Achieving ISO 13485 certification and Class IIa designation is a significant undertaking. This requirement from the TGA signals to the healthcare industry that digital health solutions can and must meet the same rigorous standards as traditional medical devices.

“At Cardihab, we have been long-term advocates for the regulation of SaMD as we see compliance with quality standards and clinical evidence as essential for building trust in digital health solutions and delivering quality outcomes for patients and healthcare professionals. Regulatory compliance should not be seen as an opt in or opt out choice that technology companies can make - it’s a commercialisation requirement for all applicable solutions.”

Helen Souris, CEO, Cardihab

This achievement reinforces our commitment to helping health services deliver clinically validated care models. It’s another step forward in our mission to improve patient outcomes and empower clinicians with tools they can trust.

Thank you to our clients, partners, and team for supporting us on this journey. Together, we’re building a stronger future for cardiac care and digital therapeutics in Australia.

Cardihab Pty Ltd - Self-care monitoring web-based application software (520745)