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[Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use].
Li, Zhe; Jiang, Haixin; Wang, Jingke; Shen, Jiefang.
Affiliation
  • Li Z; General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
  • Jiang H; General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
  • Wang J; General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
  • Shen J; General Enforcement Team of Shanghai Food and Drug Administration, Shanghai, 200233.
Zhongguo Yi Liao Qi Xie Za Zhi ; 42(1): 62-63, 2018 Jan 30.
Article in Zh | MEDLINE | ID: mdl-29862751
ABSTRACT
According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Government Regulation / Indicators and Reagents Type of study: Diagnostic_studies / Etiology_studies / Risk_factors_studies Language: Zh Journal: Zhongguo Yi Liao Qi Xie Za Zhi Year: 2018 Document type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Government Regulation / Indicators and Reagents Type of study: Diagnostic_studies / Etiology_studies / Risk_factors_studies Language: Zh Journal: Zhongguo Yi Liao Qi Xie Za Zhi Year: 2018 Document type: Article