捷报频传！国内首张小型化学发光平台适配试剂CE IVDR证书花落热景生物
2024-06-17
近日，热景生物成功获得了欧盟体外诊断医疗器械法规（IVDR）下的CE认证，跻身国内少数率先获得该标准认证的IVD厂商之列。这也是国内单人份化学发光类产品获得的首张CE IVDR证书,由欧洲最有声望的认证机构之一英国标准协会（BSI）颁发。这一里程碑式成就，不仅标志着热景生物的产品符合欧盟新法规的要求，获得了国际高法规要求市场的准入许可，更彰显了我国诊断试剂行业不断提升的国际竞争力。
热景生物首批获得CE IVDR认证的产品涵盖了心肌、炎症、激素、肿瘤等多个重要临床检测领域中的14个关键诊断指标。这些产品的成功认证得益于热景生物在研发、生产、质量控制等方面，与国际高水平标准接轨的不懈追求，也印证了热景生物创新诊断产品在全球市场领先的品牌认可度。
创新诊断，价值检验。展望未来，热景生物将继续秉承“发展生物科技，造福人类健康”的使命，坚持守正创新，持续提升产品竞争力，为广大患者和医疗机构提供更多优质诊断试剂和解决方案，推动我国诊断试剂行业迈向更高峰，为全球医疗事业贡献中国力量。让我们共同期待，我国诊断试剂行业在国际舞台上绽放更加耀眼的光芒，为全球大众健康福祉带来更大贡献！
Recently, Hotgen receives its first CE IVDR Certificate for chemiluminescent immunoassays (CLIA) from BSI, one of the most reputable notified bodies for CE certifications of medical devices. This is also the first CE IVDR certificate granted to Chinese mono-test CLIA products. This certificate covers 14 Hotgen mono-test CLIA reagents concerning cardiac, hormones, inflammation, cancer and other important physiological markers, involving both class B and C reagents.
The Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices is the new EU legislation for in-vitro diagnostic (IVD) medical devices. On May 26th, 2022, the Regulation (EU) 2017/746 (IVDR) fully applies across the European Union region. The 14 newly certified products are evidences of Hotgen’s unwavering commitment to safety, quality, and effectiveness of diagnostic products, as well as loyalty to the demand of healthcare professionals and patients.
As the first CE IVDR certificate granted to a Chinese mono-test CLIA manufacturer, this certificate marks a new step in Hotgen’s endeavor to the international market. Hotgen’s mono-test CLIA solution involves innovative designs such as mono-test cartridges and durable device platforms. It has been widely recognized and accepted by over 10,000 medical institutions worldwide, as a choice of diagnostic products with precision, economy, and flexibility.
Holding the mission of “Developing biotechnology, Benefiting human health”, Hotgen will continue researching, registering, and supplying high-quality precision diagnostic products worldwide. We are fully confident in having more Hotgen products registered and recognized in the EU and around the world in near future.
