关键词: 医疗器械, 临床试验, 监管, 对策

Abstract:

In recent years, China's clinical trial supervision of medical device has achieved certain results. However, there are still some problems in the supervision of medical device clinical trials. For example, there are a large number of medical device products for clinical trials, regulatory responsibilities are not clear, clinical trials lack technical guidance, and clinical trial sponsor, investigator, CRO lack Compliance awareness. This paper analyzes the problems found in the supervision level of medical devices clinical trials in China, and gives some suggestions to solve the problems based on the supervision subjects, which has certain guiding significance for the relevant parties of medical instrument registration.

Key words: medical device, clinical trial, supervision, countermeasure