CHISON Achieves Full EU MDR Certification

CHISON has secured EU MDR  (Medical Device Regulation, EU 2017/745) certification for its complete range of full-digital color ultrasound systems, becoming one of the few manufacturers globally to successfully transition its entire product line under the rigorous new MDR standards.

The EU MDR  replacing MDD（93/42/EEC） since 2021, sets the global benchmark for medical device regulation with stricter risk management, clinical evidence requirements, and post-market surveillance - raising both safety standards and compliance challenges.

With full-range MDR certification—from compact handhelds to premium cart-based systems—CHISON is strategically positioned to accelerate our 'Global Excellence' initiative. 

This milestone establishes a new foundation for advancing smarter, more precise, and universally accessible ultrasound technologies. By empowering healthcare providers with AI-enhanced, regulation-compliant solutions, we are transforming patient care worldwide through next-generation diagnostic excellence.