What It Takes: How the Arc4Health Became a Certified Class IIa Medical Device
When it comes to health technology, trust is everything. That’s why we’re proud that the Arc4Health is not just an innovative wellness tool – but a certified Class IIa medical device under Medical Device Directive, and now recognised by the TGA in Australia. But what does that really mean? What goes on behind the scenes to achieve such a designation?
In this blog post, we take you inside the rigorous journey of certification and what it takes to meet the standards of a regulated medical device.
🔬 Understanding the Classification: What Is a Class IIa Medical Device?
Medical devices are classified based on the level of risk they pose to the user. Class IIa refers to medium-risk medical devices – more regulated than Class I (low risk), but not as intensive as Class III (high risk).
Class IIa includes products like infusion pumps, surgical clamps, and devices like Arc4Health, which deliver microcurrent therapy to support the body’s natural healing processes.
📝 The Path to Certification: A Rigorous Process
To be certified as a Class IIa medical device under the Medical Device Directive, a product must go through a comprehensive process to prove its safety, performance, and clinical efficacy.
Here’s what that process looks like:
1. Clinical Evidence & Efficacy
Arc4Health had to demonstrate that it works as intended – safely and effectively. This involves:
- Clinical data and literature reviews
- Documented user trials and real-world case studies
- Evidence of electrical safety, biocompatibility, and long-term usage
2. Quality Management System (QMS)
We maintain a robust Quality Management System certified in line with the ISO 13485 standard, which governs how the device is designed, manufactured, tested, and tracked. Every step is documented and auditable.
3. Technical Documentation
A comprehensive technical file must be submitted to a Notified Body (an independent regulatory organisation). This file includes:
- Design specifications
- Risk analysis
- Manufacturing processes
- Labelling and instructions for use
- Post-market surveillance plans
4. Risk Assessment & Compliance
The Arc4Health underwent thorough risk assessments to ensure it poses no harm to users under normal conditions. All identified risks must be mitigated and well-documented.
5. Post-Market Surveillance
Certification doesn’t end once the product hits the shelves. We are obligated to monitor performance continuously, report any adverse events, and submit data to maintain compliance. This ensures long-term safety and confidence in the product.
It is also subject to annual audits by our Notified Body, both announced and unannounced.
🫵 Why This Matters to You
The Class IIa certification is more than a regulatory checkbox – it’s your assurance that Arc4Health has been tested, scrutinised, and held to high medical standards. This means:
- It’s safe for home use.
- It has been clinically validated for its intended purposes.
- It’s manufactured under strict quality controls.
Whether you’re using Arc4Health for injury recovery, inflammation, or long-term conditions, you can feel confident knowing that it’s supported by robust science and held to the highest safety standards.
💭 Final Thoughts
Certifying Arc4Health as a Class IIa medical device is a significant achievement – and one that reflects our commitment to your wellbeing. We believe in transparency, innovation, and empowering people with safe, effective tools to support their health.
Got more questions about the certification or how Arc4Health works? We’re always here to help. Just drop us a message or check our FAQs.
