IVD China last week: Roche, QuidelOrtho, EasyDiagnosis, Dian Diagnostics and Wange Biotechnology

Roche Diagnostics Ranked Among Shanghai's Top 100 Foreign-Invested Enterprises 

In recognition of the outstanding contributions made by foreign-invested enterprises to Shanghai's economic and social development, the "2024 Shanghai Top 100 Foreign-Invested Enterprises" list was released. 

Roche Diagnostics, with its excellent performance in the Chinese market in 2023, was once again ranked among the top 100 in four categories simultaneously, becoming one of 11 enterprises to be listed in all categories at the same time.

QuidelOrtho's First Chinese Device Successfully Launched, Hunan Plant in China Commences Production

Recently, QuidelOrtho delivered the first batch of fully automated biochemistry and immunoassay analyzers from its Changsha plant in Hunan Province, China, marking the completion of its "integrated ecosystem of R&D, production, and sales" in the Chinese market. 

The commissioning of the Changsha plant not only ensures that the quality and performance match those of imported models, but also reduces storage and transportation costs, accelerates delivery, and meets medical testing needs. The delivery of localized instruments will improve the operational efficiency and quality of clinical laboratory departments, while lowering operation and maintenance costs, benefiting more patients. Moreover, primary healthcare institutions will now have access to localized high-end equipment, improving healthcare resource accessibility. QuidelOrtho will continue to promote localized production of innovative in vitro diagnostic products and strengthen local R&D efforts to meet the needs of the Chinese market.

EasyDiagnosis Immunofluorescence Series Products Win IVDR Class C Certificate

Recently, eight products from the EasyDiagnosis Immunofluorescence series obtained the CE Class C certificate under the new IVDR regulation, issued by the international independent third-party testing, inspection, and certification organization, Süddeutsche Wirtschaftsbehandlungsgesellschaft. This makes EasyDiagnosis one of the first manufacturers in China to receive IVDR certification under the new EU regulation for in vitro diagnostic medical devices. Additionally, these are the second batch of EasyDiagnosis products to obtain IVDR certification, following the certification of its blood gas reagent kit in March.

Shanghai Wange Joins Hands with Dian Diagnostics to Forge a New Blueprint for International Biosample Bank Cooperation

On 13th October, Wange Biotechnology welcomed a distinguished group of international visitors—biosample bank leaders from over ten countries, including those from Africa, the United States, and Southeast Asia—to an event at Dian Diagnostics in Hangzhou, China. The meeting focused on various topics, including the standardization of biospecimen banking, the application of cutting-edge instruments and equipment, innovations in data products, the selection and evaluation of consumables, and quality control for laboratories and sample banks.