Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device.
10.3969/j.issn.1671-7104.2023.01.015
- Author:
Lixian CAI
1
;
Limei CHANG
1
;
Yaohua LI
1
;
Ming ZHU
1
;
Hui ZHANG
1
Author Information
1. Hainan Center for Drug and Medical Device Evaluation and Service, Haikou, 570216.
- Publication Type:Journal Article
- Keywords:
Boao Lecheng;
clinical evaluation;
real-world data;
real-world study
- MeSH:
Device Approval;
Marketing;
Research Design
- From:
Chinese Journal of Medical Instrumentation
2023;47(1):83-88
- CountryChina
- Language:Chinese
-
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.
