Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 83-88, 2023.
Article
Dans Chinois
| WPRIM
| ID: wpr-971309
ABSTRACT
The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Plan de recherche
/
Agrément de dispositif
/
Marketing
langue:
Chinois
Texte intégral:
Chinese Journal of Medical Instrumentation
Année:
2023
Type:
Article
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