Five China IVD Companies Obtained EU Quality Management System Certificate (IVDR)

As a "visa" for products to enter the European market, CE certification is a mandatory requirement for product access in the EU market. From May 26, 2022, the European Union will begin to implement the In Vitro Diagnostic Medical Device Regulation EU 2017/746 (IVDR).

In the transitional stage from IVDD to IVDR, some outstanding China IVD companies have taken the lead in obtaining IVDR certificates. They are Snibe Diagnostic, Mindray, Wondfo, YHLO, and Antobio.

In December 2020, Shenzhen New Industries Biomedical Engineering Co., Ltd. announced that its agonist and tumor marker products has obtained the first IVDR CE certificate in the field of chemiluminescence in China.

In January 2021, Mindray's biochemical project β2-microglobulin (β2-mG) determination kit obtained the first biochemical project IVDR CE certificate issued by TüV in China.

In August 2021, Guangzhou Wondfo Biotech Co., Ltd. obtained the first IVDR quality management system certificate in the field of POCT in China. The glycosylated hemoglobin test kit and C-reactive protein test kit became the first group of NP products (NearPatient Testing) that obtained IVDR CE certification in China.

In October 2021, 14 products including Anti-TPO and PCT of YHLO’s luminescence project won the IVDR CE certificate issued by BSI.

In December 2021, AntoBio Diagnostics Co., Ltd. announced that its thyroid functional magnetic particle chemiluminescence series reagent has obtained the EU IVDR CE certification.