Recently, ZHUHAI LIVZON DIAGNOSTICS INC. (LivzonDx) has passed the audit and certification of the Medical Device Single Audit Program (MDSAP), and obtained the MDSAP quality system certificate issued by TÜV SÜD America Inc., an internationally renowned certification body, on November 3, 2023.

        This certification will help LivzonDx further expand global markets. We will deliver internationally competitive products while practicing our quality policy: Customer-Oriented, Continuous Improvement, Collaborative Progress, Dedicated & Efficient Operation.

About MDSAP

        The MDSAP is a unified audit program recognized and adopted by regulatory authorities of five jurisdictions: the US (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW). Built upon ISO 13485, MDSAP integrates regulatory requirements of the five participating regions. It establishes a single standardized audit process that fulfills all local regulatory audit criteria, making quality system audits more comprehensive, consistent and efficient.

LivzonDx's Quality Management System

        Quality First, Pursuit of Perfection. LivzonDx has built a full-cycle quality management system covering R&D, manufacturing, sales and post-market surveillance. The system complies with China's pharmaceutical and medical device regulations, as well as standards and rules enforced by the EU, the US, Japan, South Korea, Chinese Taiwan, Southeast Asian countries and other regions. The system runs continuously and effectively to guarantee safe and efficacious products.

        The newly obtained MDSAP certification strengthens LivzonDx's competitive edge in overseas markets and streamlines product registration access globally. It effectively cuts repetitive audit costs and optimizes corporate management efficiency. This milestone positively fuels our overseas market expansion and accelerates LivzonDx's global development roadmap.