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  • Snibe receives the 1st IVDR CE certificate of CLIA product in Asia

    Release Date:2020-12-16

    On December 15, 2020, Snibe's MAGLUMI? TSH assay and MAGLUMI?  CA 19-9 assay were certified the IVDR CE Certification by TüV SüD Product Service GmbH an EU Notified Body, making Snibe one of the first IVDR CE-certified manufacturers for CLIA products in Asia.

    Snibe IVDR Certification

    Compared with the exiting In Vitro Diagnostic Directive (IVDD, 98/79/EC), the new EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) has added more stringent requirements, although the IVDR and IVDD share the same basic regulatory process. There are two main changes. One is a wider classification range that products in Class B/C/D will also need to be involved by independent conformity assessment bodies (Notified Bodies). The other is a significant alteration in the certification process of technical document review, clinical evaluation, and post-market supervision. It therefore means tightened quality requirements are built for IVD products across the EU market.

    Base on this situation, Snibe has organized a special group for IVDR Certification to ensure products quality and quality management systems meet the IVDR requirements. Within many joint efforts from the research and development team, registration team, quality management team and others, Snibe has finally obtained the first IVDR certification (including MAGLUMI?  TSH assay and MAGLUMI?  CA 19-9 assay) in the field of chemiluminescence, which further verifies that the quality of our products reaches international standards.

    Snibe has always been upholding the spirit of quality is life, and has always been strict and even stricter than regulatory requirements to control our products, which is why Snibe become one of the first manufacturers to receive IVDR Certification. In the future, we will continually put our effort into contributing to the cause of human life and health.