suncitygroup太阳新城(中国)集团官方网站

Clinical trials of medical devices

Medical device clinical trial refers to the process of trial or verification of the safety and effectiveness of the registered medical device under normal use conditions by medical institutions that have obtained the qualification for clinical trial of medical devices (hereinafter referred to as medical institutions) in accordance with regulations. The purpose of medical device clinical trial is to evaluate whether the tested product has the expected safety and efficacy

Classification of clinical trials

Clinical trials of medical devices are divided into clinical trials and clinical validation. For medical devices that have not yet appeared on the market and whose safety and effectiveness need to be confirmed, clinical trial study of medical devices should be carried out before approval of the market. For medical devices with similar products on the market whose safety and effectiveness need to be further confirmed, clinical validation study of medical devices shall be conducted before approval of marketing.

Clinical trials of medical devices

Classification of clinical trials

International Projects

China Project

About Us

Database

400-0569-812

Database

400-0569-812