Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China

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) ha...

Descripción completa

Detalles Bibliográficos
Autores principales: Li, Hongran, Jiao, Tong, Wang, Peirong, An, Juanjuan, Deng, Gang, Sun, Lei, Dong, Jinchun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Newlands Press Ltd 2021
Materias:
Regulatory
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597659/
https://www.ncbi.nlm.nih.gov/pubmed/34779648
http://dx.doi.org/10.4155/bio-2021-0166
_version_ 1784600645960990720
author Li, Hongran
Jiao, Tong
Wang, Peirong
An, Juanjuan
Deng, Gang
Sun, Lei
Dong, Jinchun
author_facet Li, Hongran
Jiao, Tong
Wang, Peirong
An, Juanjuan
Deng, Gang
Sun, Lei
Dong, Jinchun
author_sort Li, Hongran
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8597659
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Newlands Press Ltd
record_format MEDLINE/PubMed
spelling pubmed-85976592021-11-19 Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China Li, Hongran Jiao, Tong Wang, Peirong An, Juanjuan Deng, Gang Sun, Lei Dong, Jinchun Bioanalysis Regulatory 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. Newlands Press Ltd 2021-11-15 2021-10 /pmc/articles/PMC8597659/ /pubmed/34779648 http://dx.doi.org/10.4155/bio-2021-0166 Text en © 2021 Newlands Press https://creativecommons.org/licenses/by/4.0/This work is licensed under the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/)
spellingShingle Regulatory
Li, Hongran
Jiao, Tong
Wang, Peirong
An, Juanjuan
Deng, Gang
Sun, Lei
Dong, Jinchun
Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title_full Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title_fullStr Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title_full_unstemmed Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title_short Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China
title_sort key points of technical review for the registration of sars-cov-2 nucleic acid tests in china
topic Regulatory
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597659/
https://www.ncbi.nlm.nih.gov/pubmed/34779648
http://dx.doi.org/10.4155/bio-2021-0166
work_keys_str_mv AT lihongran keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT jiaotong keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT wangpeirong keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT anjuanjuan keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT denggang keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT sunlei keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina
AT dongjinchun keypointsoftechnicalreviewfortheregistrationofsarscov2nucleicacidtestsinchina

Ejemplares similares