Research on the enhancement of the PRER efficacy for medical device under reforming supervision
10.3969/j.issn.1672-8270.2025.10.014
- VernacularTitle:监管变革下医疗器械定期风险评价报告效能提升调查研究
- Author:
Dong LI
1
;
Min ZHAO
;
Yao LI
;
Qiping WANG
;
Yan ZHAO
Author Information
1. 国家药品监督管理局药品评价中心 国家药品监督管理局药物警戒研究与评价重点实验室 北京 100076
- Publication Type:Journal Article
- Keywords:
Medical device;
Adverse events;
Risk management;
Periodic risk evaluation report(PRER);
Periodic safety update report(PSUR)
- From:
China Medical Equipment
2025;22(10):73-78
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the implementation status of periodic risk evaluation reports(PRER)for medical devices in China,so as to provide references for adapting the development of vigilance system for medical device,and improving the PRER system.Methods:A questionnaire was self-designed,which was online distributed to registrants and filing persons for medical devices,domestic agent for imported medical devices,and the relevant persons of monitoring agencies for adverse events of medical device at all grades through monitoring agencies of each provincial grade in China,so as to understand the evaluation and suggestion of the relevant agencies of medical devices for the PRER work.Combined with review status and special inspection results of all monitoring agencies for PRER,and compared with guidelines of the European Union's Periodic Safety Update Reports(PSURs),the existing issues in the PRER for medical devices in China were analyzed at present.Results:A total of 4,377 valid questionnaires were returned,the respondents by 64.95%acknowledged that PRER can aid stakeholders to identify products'risks.Additionally,the respondents by 41.28%acknowledged that the medical devices of Class I and renewal registrations need be simplify in the PRER,and the respondents by 57.69%considered the frequency of writing and submitting reports should be adjusted.Conclusion:This article combined with the requirements of pilot work of vigilance for medical device,and recommended to strengthen risk analysis in PRER,and streamline reporting formats,and improve the top-level design of safety supervision after medical devices enter the market in China.These measures will promote the supervision and management system of China for medical device to integrate with international standards,and enhance the international competitiveness of the domestically medical device industry.
