Expanding Footprint in Southeast Asia: Two New IVD Products Officially Registered in Vietnam
We are proud to announce a significant milestone in our global overseas expansion journey: two core in vitro diagnostic (IVD) products have successfully obtained official registration and full market approval in Vietnam. The newly certified product lineup includes the Diagnostic Kit for IgM Antibody to Enterovirus 71 (Colloidal Gold) and Diagnostic Kit for IgM Antibody to C. pneumoniae (Colloidal Gold). With valid national registration credentials, the two products are fully authorized for formal commercial sales, clinical testing and public health screening across Vietnam, further consolidating our strategic footprint in Southeast Asia's rapidly developing in vitro diagnostic market.
Vietnam implements rigorous and standardized supervision on imported medical devices and IVD products, complying with Decree 98/2021/ND-CP and unified ASEAN IVDD regional regulatory guidelines. The successful full-process registration approval fully proves that our products have passed strict official reviews in terms of product safety, detection accuracy, batch stability and clinical applicability. It fully demonstrates our mature quality control system and outstanding product reliability, qualifying for large-scale clinical promotion and standardized market application in overseas regions.
Developed to target prevalent infectious diseases in tropical and subtropical Southeast Asian regions, the two newly approved kits precisely cater to local primary clinical diagnosis and public health prevention demands. Wizbiotech Enterovirus 71 Antibody Detection Kit provides fast and accurate antibody detection, supporting early screening, infection assessment and effective prevention of EV71-induced hand, foot and mouth disease, a common high-risk pediatric infectious disease in Vietnam. Meanwhile, the Chlamydia Pneumoniae IgM Antibody Detection Kit realizes specific detection of acute respiratory chlamydia infection, helping medical staff quickly identify infection causes and formulate scientific treatment plans for both children and adult patients.
Supported by continuous overseas layout, our business influence in Southeast Asia has achieved steady growth. In addition to the newly approved products in Vietnam, we have established a mature product system in the Malaysian market. Up to now, we have obtained a total of 39 valid IVD product registration certificates in Malaysia, covering diversified detection scenarios such as common infectious diseases and routine physical examination screening. The dual-market certification layout of Vietnam and Malaysia greatly enhances our regional market competitiveness and builds a solid foundation for subsequent localized cooperation, channel expansion and iterative product promotion in Southeast Asia.
In the future, we will continue to focus on R&D innovation and quality optimization of IVD products, continuously launch high-quality and cost-effective diagnostic solutions that adapt to regional medical needs. We will steadily advance global regulatory certification and overseas market penetration, empower the improvement of grassroots medical diagnosis capabilities in Southeast Asia with reliable products and professional services, and create stable and long-term cooperative value for global distributors and medical partners.
