Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics' chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally.

CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation's implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU market. Compared to the IVDD directive, the IVDR regulation imposes stricter requirements on manufacturers' quality systems, as well as the safety, effectiveness, and post-market surveillance of products, demanding traceability from production to the end-user.

Addressing challenges faced by some overseas medical institutions, such as limited space, manpower shortages, and unstable sample volumes, Fosun Diagnostics' F-i1000 fully automated chemiluminescence immunoassay analyzer features a compact size, high efficiency per unit area, versatility, stability, and high sensitivity. It is equipped with over 60 detection reagents for markers such as tumors, inflammation, gastric function, thyroid function, sex hormones, liver fibrosis, and glucose metabolism, forming a comprehensive chemiluminescence solution. This meets the high requirements for quality and Turnaround Time (TAT) in the testing of clinical characteristic projects, contributing to the efficient and rational operation of laboratories.

As a rising star, Fosun Diagnostics has consistently increased its investment in the chemiluminescence field and has made significant progress in the past six months. In August, the F-i1000 was successfully installed in a tertiary hospital in Guizhou, gaining high recognition from in-house clinical laboratory physicians for its stability, practicality, and precision. In November, three chemiluminescence reagent products—human growth hormone (hGH), progastrin-releasing peptide (ProGRP), and sex hormone-binding globulin (SHBG)—obtained China Medical Device Registration Certificates, further enriching the company's menu of immunological reagents. In December, the company launched a heavyweight new product, a set of five detection reagents for cardiac biomarkers, providing the advantages of stability, accuracy, and speed to ensure precise clinical decision-making. The successful certification of the F-i1000 this time has laid a solid foundation for the company to accelerate its expansion into the international immunodiagnostics market. Currently, Fosun Diagnostics has obtained CE certification for more than 60 chemiluminescence products. In the future, the company will continue to advance the conversion of CE certification for over 100 immunodiagnostic products, providing more valuable solutions to meet the needs of domestic and international markets.

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