Dynamiker Biotechnology Secures EU CE IVDR Certification for Six In Vitro Diagnostic Products

MEDICAL DEVICES | IN VITRO DIAGNOSTICS

A Chinese diagnostics company just cleared one of the European Union's toughest regulatory hurdles—and in doing so, may have opened a door that few domestic IVD makers have managed to crack.

Dynamiker Biotechnology (Tianjin) Co., Ltd. announced that six of its in vitro diagnostic test kits have obtained CE IVDR certification under Regulation (EU) 2017/746, the bloc's most stringent medical-device regulatory framework. The certificates were issued by TÜV Rheinland Greater China, the German international testing and certification body.

The six products target invasive fungal diseases and bacterial drug resistance—two of the most pressing challenges in clinical microbiology. They span four technology platforms: dynamic chromogenic assay, enzyme-linked immunosorbent assay (ELISA), colloidal gold immunochromatography, and fluorescent immunochromatography.

A First for China's IVD Industry

What makes this certification notable is its scope. According to Zhang Wenxiang, General Manager of TÜV Rheinland's North China division, this represents the first complete set of CE IVDR certificates for a fungal testing solution issued to a domestic IVD company within the Greater China compliance system.

"The gold content of these certificates is extremely high," Zhang said at the award ceremony. "For the enterprise, the significance is substantial."

The EU's IVDR, which fully replaced the older IVDD directive (98/79/EC), imposes rigorous requirements across quality management systems, analytical and clinical performance evaluation, risk assessment, device traceability, and post-market surveillance. Since its enactment in 2017, the regulation has forced many IVD manufacturers worldwide to undergo costly recertification processes.

Six Products, Four Platforms

The certified products cover a range of clinical needs in infectious disease diagnostics:

For fungal detection: a Fungal (1,3)-β-D-Glucan Assay Kit using the chromogenic method (classified as Class B under IVDR); an Aspergillus Galactomannan Assay Kit using ELISA (Class C); an Aspergillus Galactomannan Assay Kit using fluorescent immunochromatography under the QuicGM™ brand (Class C); an Aspergillus IgG Antibody Assay Kit using ELISA (Class C); and a Cryptococcus Capsular Polysaccharide Detection Kit using colloidal gold (Class C).

For bacterial drug resistance: a Carbapenemase Detection Kit using colloidal gold (Class C).

The product mix signals Dynamiker's strategy of building a multi-technology portfolio rather than betting on a single platform—a approach that could give it flexibility in different market settings, from well-equipped reference laboratories to point-of-care facilities in resource-limited environments.

"Go Global or Exit"

Liu Shigui, Dynamiker's chief scientist, credited the certification process to close collaboration with TÜV Rheinland's team, noting that the certifiers provided "a large amount of professional and valuable input" that helped streamline the company's registration and product validation workflows.

But Liu made clear that the company sees these six products as a starting point, not a finish line. Dynamiker plans to screen additional products based on overseas market demand and continue pursuing international certifications.

Zhang struck a broader note about the stakes for Chinese IVD companies considering expansion abroad. "There's a saying in the industry: go overseas, or exit the game," he said. "There is massive demand in overseas markets. After years of development, the quality and quality-control systems of domestic medical device products have matured, and they have the foundation to go global."

TÜV Rheinland, which has operated in China for decades, has helped numerous domestic medical device companies navigate international regulatory frameworks. Zhang said the organization plans to continue upgrading its professional capabilities across its global network to provide what he called "professional and efficient compliance services."

For Dynamiker—a publicly listed company trading under stock code 920009—the CE IVDR certifications mark a milestone in its transition from a domestic player to a global contender. The real test, however, will be whether the company can convert regulatory clearance into commercial traction in markets where established competitors already hold strong positions.