Major Regulatory Achievement
AOJ Medical recently achieved a significant milestone. We received the CE (MDR) certificate in October 2022. This certification complies with the new European Medical Device Regulation. Specifically, it covers our entire professional product line. Consequently, AOJ Medical joins the first batch of certified Chinese manufacturers. TÜV SÜD issued this prestigious certificate to our team.
Scope of Certified Products
The certificate includes our non-invasive blood pressure monitors(NIBP). Furthermore, it covers our high-accuracy pulse oximeters. We also secured certification for our digital thermometers. These products now meet the strictest European safety standards. Therefore, we can freely supply these devices across the EU. This “VISA” ensures our products reach more global patients.
Commitment to Stricter Standards
The MDR framework replaces the old MDD directive. It establishes a more robust legislative framework for health. For instance, it requires stricter product risk management. Moreover, it demands higher clinical evaluation standards. AOJ Medical consistently invests in R&D and quality compliance. Therefore, we successfully met these challenging regulatory requirements. Our quality management system ensures total product effectiveness.
Supporting Global Market Growth
We prioritize global certifications for all our devices. This success strengthens our position as a medical device manufacturer. Additionally, we focus deeply on product quality and safety. We will continue helping customers develop the EU market. Specifically, we provide reliable supply chain services worldwide. In conclusion, AOJ Medical remains your trusted partner for innovation.