Good News! The first 69 products of Biotest obtained the EU IVDR certificate

Recently, Hangzhou Biotest Biotech obtained the CE certificate (IVDR) issued by TÜV SÜD, an authoritative EU notified body, under the IVDR regulation, which covers the first batch of 69 products of the company. The first batch of certified products mainly focus on the field of drug abuse testing, and also cover some items in the fields of infectious disease testing, women's health testing and tumor marker testing. The issuance of this batch of certificates makes Biotest one of the first manufacturers in China to have a more complete range of EU IVDR certified drug abuse testing products.

CE certification is a pass for products to enter the market circulation in the EU and European Free Trade Area countries, representing that the product complies with the EU laws, regulations and standards related to the product, and is a commitment of the enterprise to consumers, which can increase the trust of consumers in the product and at the same time reduce the risk of selling in the European market.

The new EU In Vitro Diagnostic Medical Devices CE Certification Regulation (IVDR, EU2017/746) was officially published and came into force on May 25, 2017 and will be implemented from May 26, 2022. 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 products that have obtained CE certification before May 26, 2022 will be gradually switched over during the transition period according to the risk level. The new IVDR regulation classifies IVD products into four categories, with risk ranked from low to high: Class A, Class B, Class C and Class D. Class A is sterile, while Class B, C and D require the EU Notification Body (Notify Body) to issue certificates before the products can enter the EU market. The new IVDR regulation aims to establish a modern and stricter regulatory framework in order to better protect the health and safety of the public and patients. Compared with the IVDD Directive, the IVDR Regulation imposes stricter requirements on manufacturers' quality systems and on the safety, efficacy and post-market surveillance of products, and requires products to meet traceability from production to endpoint.

The acquisition of the IVDR certificate for quality management system and IVDR certificates for several products is another milestone breakthrough since the company was listed on the Science and Technology Board and obtained the Medical Device Single Audit Procedure (MDSAP) certificate, which is of great significance in practicing the company's quality policy and differentiated product development strategy. The acquisition of the new IVDR certificate marks, on one hand, that Biotest has become a medical device manufacturer that meets the requirements of the new EU in vitro diagnostic medical device regulations for IVDR CE certification, laying a solid foundation for the subsequent switchover of the company's other products to EU certification. On the other hand, it is also a recognition of the hard work of all IVDR project participants in the past year, and inspires Biotest people to complete the IVDR registration of subsequent products faster and with higher quality.

The new IVDR quality management system certificate and IVDR product certification have also brought positive impact in marketing. The new IVDR certification will not only promote the sales growth of related products in the EU region, but also help the registration and certification of related products in non-EU regions. With this IVDR certification, Biotest will accelerate the improvement of the global layout of its product line and bring more convenient and instant diagnostic services to people around the world.

About Biotest

Founded in 2008, Hangzhou Biotest Biotech Co., Ltd. is a national high-tech enterprise that mainly develops and produces rapid diagnostic reagents. Our leading products include infectious disease testing, drug abuse testing, tumor marker testing, cardiac marker testing and reproductive health testing series, which are widely used in hospitals, CDCs, blood stations, drug treatment bans and third-party testing institutions at all levels. Biotest focuses on independent research and development of products and technology accumulation, and has a highly innovative and pioneering R&D team, which provides many patented technologies and innovative product development for enterprises every year. Relying on strong research and development and technological innovation capabilities, the company is in the leading position in the research of cutting-edge biological fields such as colloidal gold, latex, fluorescence and other labeling technologies, mono/polyclonal antibodies, genetic recombinant antigens, synthetic antigens and other biological raw materials technologies, as well as immunochromatographic technologies. Adhering to the principle of quality first, Biotest has obtained several quality system certifications, including ISO13485 quality system certification, NMPA quality system certification, and MDSAP quality system certification recognized by many countries, including the United States, Canada, Brazil, Japan, Australia, etc.