[Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items].
change of licensing item
countermeasure
medical device
technical evaluation
Journal
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
ISSN: 1671-7104
Titre abrégé: Zhongguo Yi Liao Qi Xie Za Zhi
Pays: China
ID NLM: 9426153
Informations de publication
Date de publication:
30 Jul 2019
30 Jul 2019
Historique:
entrez:
29
8
2019
pubmed:
29
8
2019
medline:
17
10
2019
Statut:
ppublish
Résumé
Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.
Identifiants
pubmed: 31460726
doi: 10.3969/j.issn.1671-7104.2019.04.017
doi:
Types de publication
Journal Article
Review
Langues
chi
Sous-ensembles de citation
IM