捷報(bào)頻傳！國(guó)內(nèi)首張小型化學(xué)發(fā)光平臺(tái)適配試劑CE IVDR證書花落熱景生物
2024-06-17
近日，熱景生物成功獲得了歐盟體外診斷醫(yī)療器械法規(guī)（IVDR）下的CE認(rèn)證，躋身國(guó)內(nèi)少數(shù)率先獲得該標(biāo)準(zhǔn)認(rèn)證的IVD廠商之列。這也是國(guó)內(nèi)單人份化學(xué)發(fā)光類產(chǎn)品獲得的首張CE IVDR證書,由歐洲最有聲望的認(rèn)證機(jī)構(gòu)之一英國(guó)標(biāo)準(zhǔn)協(xié)會(huì)（BSI）頒發(fā)。這一里程碑式成就，不僅標(biāo)志著熱景生物的產(chǎn)品符合歐盟新法規(guī)的要求，獲得了國(guó)際高法規(guī)要求市場(chǎng)的準(zhǔn)入許可，更彰顯了我國(guó)診斷試劑行業(yè)不斷提升的國(guó)際競(jìng)爭(zhēng)力。
熱景生物首批獲得CE IVDR認(rèn)證的產(chǎn)品涵蓋了心肌、炎癥、激素、腫瘤等多個(gè)重要臨床檢測(cè)領(lǐng)域中的14個(gè)關(guān)鍵診斷指標(biāo)。這些產(chǎn)品的成功認(rèn)證得益于熱景生物在研發(fā)、生產(chǎn)、質(zhì)量控制等方面，與國(guó)際高水平標(biāo)準(zhǔn)接軌的不懈追求，也印證了熱景生物創(chuàng)新診斷產(chǎn)品在全球市場(chǎng)領(lǐng)先的品牌認(rèn)可度。
創(chuàng)新診斷，價(jià)值檢驗(yàn)。展望未來(lái)，熱景生物將繼續(xù)秉承“發(fā)展生物科技，造福人類健康”的使命，堅(jiān)持守正創(chuàng)新，持續(xù)提升產(chǎn)品競(jìng)爭(zhēng)力，為廣大患者和醫(yī)療機(jī)構(gòu)提供更多優(yōu)質(zhì)診斷試劑和解決方案，推動(dòng)我國(guó)診斷試劑行業(yè)邁向更高峰，為全球醫(yī)療事業(yè)貢獻(xiàn)中國(guó)力量。讓我們共同期待，我國(guó)診斷試劑行業(yè)在國(guó)際舞臺(tái)上綻放更加耀眼的光芒，為全球大眾健康福祉帶來(lái)更大貢獻(xiàn)！
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.
