Following the first batch of 69 products obtained the CE IVDR certificate issued by the EU notified body TÜV SÜD in June last year, Biotest EU IVDR product registration has spread good news again, the company's gastric Helicobacter pylori (H.pylori) series of test reagents, including antigen and antibody detection products, successfully obtained the CE IVDR certificate issued by the authoritative notified body BSI Netherlands. Certificate issued by the authoritative notification organization BSI Netherlands! This indicates that the H. pylori test reagents developed and manufactured by Biotest have complied with the latest EU In Vitro Diagnostic Regulation (IVDR) 2017/746, which meets the criteria for marketing in the EU and the European Free Trade Area (EFTA) countries.
The issuance of the new IVDR certificate demonstrates that Biotest 's registration work for the EU CE marking regulation for in vitro diagnostic medical devices has been recognized by two mainstream Notified Bodies (TÜV Süd and BSI Netherlands). With this, a total of 72 products of Biotest have received CE IVDR certification in the European Union.
The new EU Regulation on CE marking of in vitro diagnostic medical devices (IVDR, EU2017/746) was officially published and came into force on 25 May 2017, and started to be implemented from 26 May 2022 onwards. Since the implementation date, the EU IVDR regulation will replace the former EU In Vitro Diagnostic Medical Devices Directive (IVDD,98/79/EC) to regulate in vitro diagnostic medical devices in the EU market, and the products that have obtained CE marking before 26th May 2022 will gradually complete the switchover during the transition period according to the risk level. The new IVDR regulation product risk level IVD products are divided into four categories, the risk from low to high ranking: Class A, Class B, Class C, Class D, which Class A class sterile, Class B, C, D need to be issued by the EU Notified Body (Notified Body) to enter the EU market. The new IVDR regulation aims to establish a modernized and stricter regulatory framework to better protect public and patient health and safety.
Under the background of the implementation of IVDR regulation, the EU regulatory requirements for in vitro diagnostic medical devices have become more stringent and complex. Biotest always stands at the forefront of the industry, quickly adapts to regulatory changes, drives development with innovation, constantly breaks through technical bottlenecks, ensures that its products comply with international high-level standards, and successfully passes the audits of many notified organizations, which shows the company's perfect quality management system and strong market resilience. In the future, Biotest will continue to uphold the core concepts of innovation, quality and compliance to provide global customers with more high-quality and reliable in vitro diagnostic solutions.
About Us
Founded in 2008, Hangzhou Biotest Biotech Co., Ltd is a national high-tech enterprise which mainly develops and produces rapid diagnostic reagents. The company's leading products include infectious disease test, drug abuse test, tumor marker test, cardiac marker test and reproductive health test series, which are widely used in all levels of hospitals, CDC, blood stations, drug rehabilitation and third-party testing institutions. Biotest focuses on the independent research and development of products and technology accumulation, with a highly innovative and pioneering ability of the R & D team, every year for the enterprise to provide a number of patented technologies, as well as the development of innovative products. Relying on the strong research and development and technology innovation ability, the company is in the leading position in the domestic research in colloidal gold, latex, fluorescence and other labelling technologies, mono/polyclonal antibodies, recombinant antigens, synthetic antigens and other biological raw materials, as well as immunochromatography and other cutting-edge biological fields. Adhering to the principle of quality first, Biotest has obtained a number of quality system certifications, including ISO13485 quality system certification, NMPA quality system certification, and has passed the MDSAP quality system certification recognized by a number of countries, including the United States, Canada, Brazil, Japan, Australia, and so on.
