By December 2025, HOKAPI has completed the IVDR registration process of 3rd wave CLIA reagents.

In addition to the 4 new issued IVDR certificates this time (Gastrin-17, PIVKA-Ⅱ, Vitamin B12, Folate), HOKAPI has acquired a total of 53 IVDR certificates for CLIA reagents. It strengthens our compliance layout for out of China market, laying a solid foundation for global market access.

Newly issued parameters precisely meets the core clinical needs

The 4 parameters IVDR approved are indispensable in clinical testing scenarios, enhancing diagnosis efficiency as well as guarding the health of patients.

Gastrin-17, for accurately identifying gastric dysfunction, providing reliable information for screening of gastritis, gastric ulcers or precancerous lesions.

PIVKAⅡ, carry out dynamic monitoring for confirmed liver cancer patients, assist in judging the disease progression, or the effectiveness of the treatment.

Vitamin B12 & Folate, the indicators determining anemia, achieving rapid and precise quantitative detection. Combined with Ferritin, HOKAPI can provide full anemia panel to support diagnosis of common types of anemia in clinical practice.

IVDR certification milestones

In 2021, a professional team was established, focusing on interpretation of EU regulations and CLIA reagents R&D, laying the foundation for IVDR submission.

In December 2022, the 1^st wave including 13 parameters were IVDR CE certified, achieving a breakthrough from 0 to 1.

In October 2024, the 2^nd wave including 36 parameters were certified, covering multiple panels such as tumor markers, thyroid, cardiac, inflammation, and hormones.

In December 2025, the 3^rd wave of 4 parameters were issued, reaching totally 53 IVDR certificates approved, in which the anemia panel was fully upgraded.

As a "golden key" for in-vitro diagnostic devices enter into many regions including European market, the high standards of the IVDR certification represent a comprehensive recognition of the enterprise's R&D capability, quality management system, the effectiveness and safety of the products.

The successful approval of our IVDR certificates indicates HOKAPI have fully met the high EU regulatory standards, who is willing to deepen its focus on IVD field and meet the global clinical needs.