The First IVDR-Certified Blood Glucose System Manufacturer in Taiwan!

We are thrilled to announce a major milestone for General Life Biotechnology and our valued partners. After two years of dedicated effort, we have successfully obtained full certification under the European Union's stringent In Vitro Diagnostic Regulation (IVDR, EU 2017/746).

This achievement officially makes us the first manufacturer in Taiwan to be IVDR-certified for blood glucose monitoring systems, placing our products at the forefront of global regulatory compliance.

An Unprecedented Success: Our 3-in-1 System's Comprehensive Certification

What makes this achievement particularly significant is the complete, simultaneous certification of our entire 3-in-1 multi-function monitoring system. This includes all three of its core test strips:

• Blood Glucose Test Strips
• Uric Acid Test Strips
• Total Cholesterol Test Strips

By certifying the entire system at once, rather than one component at a time, we have demonstrated a level of product integration and quality assurance that sets a new industry benchmark. This accomplishment is a direct reflection of our robust R&D and quality control processes.

Our Unwavering Commitment to Global Standards

For our partners and their customers, this certification is a guarantee of quality and safety. The IVDR is the new gold standard for medical devices, replacing the previous IVDD directive with much stricter requirements for clinical evidence, risk management, and post-market surveillance. Our compliance assures you that our products meet the highest international standards for performance and reliability.

Looking Ahead: Our Promise to You

This is just the beginning. We are already moving forward with the IVDR certification process for our other product lines and are excited to be developing new, innovative solutions to expand our portfolio.

Our mission is to empower you, our global partners, with a comprehensive and competitive range of diagnostic tools you can trust. We are incredibly proud of what our team has accomplished and deeply grateful for the confidence you place in our products.

If you have any questions about our IVDR-certified system or wish to discuss partnership opportunities, please contact us. We look forward to achieving new successes together.