Whole-process quality-based strategies for good clinical practice when using oral medical devices / 口腔疾病防治

ABSTRACT

@#Clinical trials are the key step in verifying the effectiveness, safety and usability of novel oral medical devices. With improvements in invention capability, the number of clinical trials of medical devices has steadily increased domestically, indicating the need for new requirements for quality management. Here, on the basis of summarizing the characteristics of clinical trials for oral medical devices in China, we proposed a whole-process quality-control model for good clinical practice (WQGCP). This model clarified the management specifications for oral medical device clinical trials in the new era. It indicates that the clinical trial design is the breakthrough point, while whole-process risk control is the key point. This suggests the need for the establishment of a quality management cooperation system, evaluation and postevaluation systems and the training of high-level personnel who conduct clinical trials. It also provides suggestions to promote the participation of oral clinicians in high-quality research and invention of novel clinical medical devices with the aim of accelerating the development of oral medical devices in China.