The European Commission (EC) has proposed an extension of the transition period for the IVDR, aiming to maintain the availability of essential healthcare products and ensure patient care.

The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.

ARUP Laboratories said Friday its companion diagnostic to help identify which patients are eligible for treatment with a gene therapy for hemophilia A received CE marking under the European Union's In Vitro Diagnostics Regulation (IVDR).

EliTechGroup announced on Thursday that it has received certification under Europe's In Vitro Diagnostic Regulations for multiple infectious disease tests.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.