Dual drivers of the EU IVDR regulatory upgrade and frequent global infectious disease outbreaks are fueling a new golden era for the globalization of China’s POCT (Point-of-Care Testing) industry.

Fully enforced in 2026, the EU IVDR has replaced the outdated IVDD directive with stricter unified standards for clinical validation, EUDAMED UDI registration and technical documentation. It eliminates low-quality non-compliant products and raises the global entry threshold for in vitro diagnostics. For Chinese POCT manufacturers with mature manufacturing systems and proactive IVDR certification layouts, this rigorous regulation has become a core competitive advantage. Mass certified Chinese rapid detection reagents and portable molecular POCT devices have gained universal recognition in the EU, Middle Eastern and Latin American markets, securing broad cross-border market access.

Meanwhile, global public health demands further boost industry growth. The ongoing Central African Ebola outbreak, as well as rising surveillance needs for tuberculosis and zoonotic viruses, have driven the WHO and regional institutions to massively deploy portable, fast and lab-independent POCT testing solutions. Chinese POCT products stand out globally for their reliable performance, cost-effectiveness and convenient on-site operation, perfectly matching the testing pain points of grassroots and resource-limited regions worldwide.

In summary, standardized global regulations and surging overseas market demand have jointly created unprecedented development opportunities for China’s POCT export sector. Keeping pace with global regulatory updates and market trends, Alltest continuously focuses on in-depth technological research and development. Centered on actual customer demands and industry pain points, the company persists in technological innovation and product iteration to deliver high-quality, market-adaptive POCT solutions for global clients.