Key Points of Technical Review for the Registration of Sars-Cov-2 Nucleic Acid Tests in China | Zendy

Hongran Li | Zendy; Tong Jiao | Zendy; Peirong Wang | Zendy; Juanjuan An | Zendy; Gang Deng | Zendy; Lei Sun | Zendy; Jinchun Dong | Zendy

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Key Points of Technical Review for the Registration of Sars-Cov-2 Nucleic Acid Tests in China

Author(s) -

Hongran Li,

Tong Jiao,

Peirong Wang,

Juanjuan An,

Gang Deng,

Lei Sun,

Jinchun Dong

Publication year - 2021

Publication title -

bioanalysis

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.566

H-Index - 58

eISSN - 1757-6199

pISSN - 1757-6180

DOI - 10.4155/bio-2021-0166

Subject(s) - key (lock) , covid-19 , risk analysis (engineering) , computer science , pandemic , product (mathematics) , quality (philosophy) , computer security , business , medicine , outbreak , virology , pathology , philosophy , geometry , disease , mathematics , epistemology , infectious disease (medical specialty)

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 of Technical Review for the Registration of SARS-CoV-2 Nucleic Acid Tests ( 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.

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