中国新型冠状病毒(SARS-CoV-2)核酸检测试剂注册技术审评要点
Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China.
机构信息
Center for Medical Device Evaluation, NMPA, 50 Qixiang Road, Haidian District, Beijing, 100081, China.
出版信息
Bioanalysis. 2021 Dec;13(23):1731-1741. doi: 10.4155/bio-2021-0166. Epub 2021 Nov 15.
Abstract
In response to the outbreak of COVID-19, in accordance with the principles of 'unified command, early involvement, prompt review and scientific approval' as well as the requirements of ensuring product safety, effectiveness and controllable quality, the Center for Medical Device Evaluation (CMDE) has issued (Key Points) to provide the requirements of tests. Because of the sustainability of the pandemic, more efforts and attempts are needed for SARS-CoV-2 detection and control. This article interprets the Key Points issued by the CMDE and provides certain refinements to wider audiences.
摘要
针对 COVID-19 疫情，根据“统一指挥、早期介入、快速评审、科学审批”的原则以及确保产品安全性、有效性和质量可控性的要求，医疗器械技术审评中心（CMDE）发布了（要点），以提供测试要求。由于大流行的持续性，需要对 SARS-CoV-2 的检测和控制进行更多的努力和尝试。本文解读了 CMDE 发布的要点，并为更广泛的受众提供了一定的改进。
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