Regulatory Clearances & Certifications

At IBD Medical, we recognise that trust, safety, and quality are essential for individuals managing diabetes. Every Glucology® product is developed with the highest commitment to regulatory compliance and international standards.

Our range of devices and accessories carries recognised approvals and clearances across multiple regions, ensuring they meet strict safety and performance requirements.

✅ FDA Clearances (United States)

The following Glucology® products have been granted FDA clearance for distribution in the United States:

• Sharp Bin Containers – for safe and compliant disposal of sharps.

• Insulin Cooling Bags – tested to ensure reliable cooling and medicine protection.

• CGM Patches – hypoallergenic and skin-safe patches designed for secure device adhesion.

• Insulin Pump Belts – medically approved for safe use in managing insulin pumps.

• Diacare Socks – designed with copper and diabetic-friendly materials to help protect sensitive feet.

In addition, our Glucochews are manufactured in an FDA-approved facility, ensuring pharmaceutical-grade quality and consistency.

✅ TGA Registrations (Australia)

In Australia, all medical devices must be registered with the Therapeutic Goods Administration (TGA). Our TGA-registered products include:

• Lancets

• Lancing Devices

• Glucology Skin Cleaning Wipes

• Blood Glucose Monitors

• Blood Glucose Test Strips

This registration ensures our devices meet Australia’s high standards of safety, quality, and performance.

✅ CE Mark (European Union & UK)

Many Glucology® products also carry the CE Mark, demonstrating compliance with the essential health, safety, and performance requirements of the European Union and the United Kingdom. This clearance ensures our products can be marketed and trusted across Europe and other CE-recognising regions.

🌍 Global Certifications

In addition to FDA, TGA, and CE approvals, many of our products hold further international certifications and test reports, demonstrating compliance with global safety and quality standards. Certificates are available on request for healthcare professionals and partners.

Our Commitment

Every step of our design, testing, and manufacturing process is guided by our mission to ease the burden of managing diabetes. By securing these clearances and certifications, we give our community confidence that every Glucology® product is safe, reliable, and backed by science.