Does The Approval Of The Clinical Trial Application Also Approve The Clinical Trial Plan?

The aim of the clinical trial approval for class HI of high- risk medical device is to make a decision on whether to agree to conduct a clinical trial based on the application. The purpose is to protect the rights and interests of the subjects. The review focuses on preclinical research, clinical benefit and risk analysis of the product. The design of clinical schemes may affect the risks and benefits of clinical trials to subjects. Therefore, clinical trial plans are one of the review contents of clinical trial approval applications. However, the clinical trial approval process does not finalize the clinical trial plan submitted by the administrative counterpart. The administrative counterpart can refer to the communication with the review and approval personnel during the clinical device approval and registration process of the medical device, and modify and improve the clinical trial plan in accordance with the requirements of the GCP. The technical review agency will give a comprehensive evaluation of the safety and effectiveness of the product in the subsequent review and approval process.