Risk Assessment before Conducting Clinical Trials of Medical Devices
10.12026/j.issn.1001-8565.2023.08.02
- VernacularTitle:医疗器械临床试验开展前的风险评估
- Author:
Qiansu YANG
1
;
Nan BAI
1
;
Jiang CAO
1
;
Juan XU
1
;
Jin WANG
1
Author Information
1. Drug Clinical Research Laboratory, the PLA General Hospital Medical Security Center Pharmacy Department, Beijing 100853, China
- Publication Type:Journal Article
- Keywords:
Medical Device;
Clinical Trial;
Risk Assessment;
Medical Ethics;
Ethical Review
- From:
Chinese Medical Ethics
2023;36(8):834-839
- CountryChina
- Language:Chinese
-
Abstract:
Due to the rapid development of new medical devices and the national policy adjustment of medical device review and approval, the difficulty of clinical trial institution and ethics committee in the risk assessment of medical device clinical trials has greatly increased. By sorting out the legal norms, standards and safety evaluation materials of medical devices, this paper systematically summarized and suggested the existing risks in clinical trials of medical devices from seven aspects, including the collection and utilization of biological sample, site environment safety, information security, product production and inspection, use of device, clinical trial design, and technical capabilities, with a view to providing a reference basis for the sponsors, clinical trial institutions, and ethics committees to scientifically establish a risk assessment system for medical devices before clinical trials, thereby reducing potential risks of compliance and safety during the clinical trial process.
